COVID-19 PORTFOLIO

GlaxoSmithKline United Kingdom

Description:
Sotrovimab is a neutralizing monoclonal antibody against SARS-CoV-2 for the treatment of mild-to-moderate COVID-19 in non-hospitalized adult and pediatric (12 years and older and at least 40 kg) patients at high risk for severe COVID-19.

Unique Impact:
Sotrovimab maintains in vitro activity against most circulating variants of concern, with the exception of BA.2, for treating mild-to moderate COVID-19 in high risk patients to prevent hospitalization and death. Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.

Status: No Longer Authorized

Cost Share: No

Aptitude Medical Systems, Inc USA

Description:
The Metrix COVID/Flu Test is a rapid molecular test for detection and differentiation of SARS-CoV-2, influenza A and B from saliva and nasal swab samples and provides results in 15-30 minutes at home.

Unique Impact:
Should saliva samples prove effective for influenza testing, the proposed test would uniquely use saliva in an at-home test setting, increasing test comfort and expanding test access by offering patients more sample options.

Cost Share: No

Aptitude Medical Systems, Inc USA

Description:
Aptitude’s Metrix COVID-19 Test is a rapid molecular test for sensitive and specific detection of SARS-CoV-2 from saliva and nasal swab samples in 15-30 minutes at home.

Unique Impact:
The proposed tests would use saliva or nasal samples in an at-home test setting, increasing test comfort and expanding test access by offering patients more sample options.

Merck USA

Description:
LAGEVRIO (molnupiravir) is an oral antiviral for the treatment of mild to moderate COVID-19 in adults with positive SARS-CoV-2 test results who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate. It inhibits viral replication by inducing genetic copying errors during viral replication (mutagenesis).

Unique Impact:
LAGEVRIO (molnupiravir) is the second FDA emergency use authorized oral antiviral for treatment of COVID-19. It is an orally available antiviral agent that can be administered to non-hospitalized adult patients and has the potential to mitigate disease progression.

Status: EUA Issued

Cost Share: No

Pfizer Inc. USA

Description:
PAXLOVID is a SARS-CoV-2 main protease (Mpro, or 3CL) inhibitor nirmatrelvir antiviral therapy combined with ritonavir; it was developed to be administered orally so that it can be prescribed at the first sign of infection. Nirmatrelvir is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate, and is co-administratered with a low dose of ritonavir.

Unique Impact:
PAXLOVID is the first protease inhibitor to treat COVID-19 procured by the USG. In addition to ease of administration that simplifies outpatient treatment, oral antiviral medications increase access to treatments within the community. PAXLOVID is highly effective against SARS-CoV-2 and nirmatrelvir has shown consistent in vitro antiviral activity against current variants of concern. It also has activity against other coronaviruses in the laboratory. The mechanism of action has potential to treat future coronavirus outbreaks/pandemics.

Status: EUA and Approved

Cost Share: No

DiaSorin Molecular LLC USA

Description:
The LIAISON NES will be a small, lightweight, CLIA-waived POC instrument capable of running an RT-PCR assay in 15 minutes to detect SARS-CoV-2 and influenza A&B viruses from swab samples.

Unique Impact:
The LIAISON NES is designed to unlock the massive potential beyond the clinical lab, including pharmacies to support infectious disease detection and control. The small, lightweight, CLIA-waived device is designed to be plug and play with less than one minute hands-on time. The instrument will deliver lab quality results in about 15 minutes from a swab sample.

Cost Share: No

BioFire Defense, LLC USA

Description:
The BioFire Emerging CoV panel is a nucleic acid amplification test panel for use on the easy-to-use FilmArray 2.0 and FilmArray Torch platforms. The Emerging CoV Panel will include pan-coronavirus assays to detect known, novel and emerging coronaviruses in nasopharyngeal swab specimens.

Unique Impact:
Early detection of an emergent coronavirus, before it reaches pandemic level, could allow for containment of infected patients and virus and could provide the scientific community time to develop effective medical countermeasures resulting in less social, economic and security disruptions.

Cost Share: No

Diazyme Laboratories, Inc. USA

Description:
Diazyme’s SARS-CoV-2 Neutralizing Antibody CLIA Kit is a fast, high-throughput and fully automated assay that directly detects total SARS-CoV-2 neutralizing antibodies (nAb).

Unique Impact:
Diazyme will develop a fast and high-throughput SARS-CoV-2 test that specifically measures total neutralizing antibodies to the SARS-CoV-2 virus.

Cost Share: No

Moderna US, Inc. USA

Description:
Moderna COVID-19 vaccine booster candidate, mRNA-1273.222, is a bivalent vaccine candidate containing Spikevax plus the Omicron BA.4/5 strain mRNA.

Unique Impact:
The Moderna COVID-19 vaccine booster candidate, mRNA-1273.222, targets the Omicron variants by adding the Omicron BA.4/5 spike protein component to Spikevax, creating a two component (bivalent) vaccine. If authorized, this booster vaccine will be indicated for active immunization to prevent COVID-19.

Updates:
Purchase of 66M doses of Moderna’s COVID-19 booster vaccine, targeting circulating Omicron variants.

Cost Share: No

Eli Lilly and Company USA

Description:
Bebtelovimab is a novel monoclonal antibody authorized for treatment of mild to moderate COVID-19 in adults and pediatric patients (at least 12 years old and weighing at least 40 kg) who are at high risk for progression to severe COVID-19, and for whom alternative COVID-19 FDA-approved or authorized treatment options are not accessible or clinically appropriate.

Unique Impact:
Bebtelovimab is a new monoclonal antibody therapeutic. Data suggests that the product has activity against known variants of concern, including Omicron and its subvariants.

Status: No Longer Authorized

Cost Share: No

Pfizer Inc. USA

Description:
Pfizer will conduct large-scale manufacturing and fill-finish of its COVID-19 mRNA vaccine, developed in collaboration with BioNTech, for distribution in the US after Emergency Use Authorization and/or licensure is granted by the FDA.

Unique Impact:
Pfizer’s COVID-19 vaccine is an mRNA vaccine that is delivered in lipid nanoparticles. RNA delivered by these protein-free lipid nanoparticles is believed to eliminate the risk of anti-vector immunity while boosting the level and duration of immune responses. Additionally, the use of mRNA technology potentially allows for rapid manufacturing scale-up that is critical for prevention of COVID-19.

Status: Licensed

Philips North America USA

Description:
BARDA & Philips Research are collaborating to expand the capability of their compact Philips Lumify, an AI-based multi-functional hand-held ultrasound system, with predictive machine-learning (ML) algorithms, to provide Automatic and Intelligent Quantitative Assessment of Lung Injuries, Diseases and Traumatic Injuries in a Mass-Casualty Incident.

Unique Impact:
A hand-held ultrasound system & new 3D-transducer enhances the capability available to burn, trauma and emergency physicians for faster, better-informed triage for patients with burn & blast injuries. The new technology for imaging lung injury has potential for broad use, from smoke inhalation to pneumonia from viral infections such as COVID-19.

Lumen Bioscience USA

Description:
Spirulina-derived, high affinity, intranasally-administered antibody for treatment or pre-exposure prophylaxis of SARS-CoV-2 infection

Unique Impact:
Passive immunization (i.e., monoclonal antibodies [mAbs]) is a key medical countermeasure for pandemics. However, mAbs require costly and time-intensive manufacturing processes and administration by trained personnel. Lumen Bioscience developed a low-cost, rapid, scalable method of antibody manufacturing that would broaden their pandemic utility.

Cost Share: Yes

AstraZeneca USA

Description:
Support development of a monoclonal antibody combination (tixagevimab and cilgavimab) for pre-exposure prophylaxis (prevention) of COVID-19. This award funds late stage clinical trials and large scale manufacturing demonstration of the mAb product as well as distribution.

Unique Impact:
EVUSHELD is the only monoclonal antibody product authorized in the US to prevent COVID-19 by providing protection against SARS-CoV-2 virus before exposure in certain immune compromised populations, including for adult and pediatric patients (aged 12 and over weighing at least 40 kg). EVUSHELD has in vitro activity against the Omicron variant and BA.2 subvariant. The drug product is being developed by AstraZeneca with DARPA and BARDA.

Status: No Longer Authorized

Cost Share: Yes

Detect Inc. USA

Description:
The Detect COVID/Flu test is a rapid molecular test for home use that identifies and distinguishes SARS-CoV-2 and influenza A and B in less than 30 min.

Unique Impact:
The Detect contract will develop a next generation molecular test for COVID-19 and flu using a nasal swab. The multiplex test is rapid and is designed for home use. It includes a reusable base station, a single-use cartridge and a mobile app.

Cue Health Inc. USA

Description:
The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic).

Unique Impact:
This test is capable of detecting SARS-CoV-2 in less than 25 minutes using a simple nasal swab. The test is part of the Cue Health Monitoring System, which is designed to be a portable device that can perform a molecular test and connect patients to a mobile health platform. The FDA's De Novo classification of the test can empower individuals with accurate, accessible, and actionable diagnostic tools for at home detection of COVID-19.

Status: Cleared

Eli Lilly and Company USA

Description:
Bamlanivimab and etesevimab, administered together, are monoclonal antibodies for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, including neonates (babies 4 weeks old or younger), with positive SARS-CoV-2 test results, who are at high risk for progression to severe COVID-19, including hospitalization or death.

Unique Impact:
Bamlanivimab and etesevimab are neutralizing monoclonal antibodies that bind to distinct but overlapping epitopes within the receptor binding domain of the spike protein of SARS-CoV-2. In clinical studies, bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death when compared to placebo.

Updates:
Distribution is currently paused.

Status: No Longer Authorized

Cost Share: No

BD (Becton Dickinson and Company) USA

Description:
A molecular test that detects and distinguishes SARS-CoV-2, Influenza A and B, and RSV. This is a medium-throughput test for use in acute-care settings.

Unique Impact:
The BD contract will develop an integrated suite of FDA-cleared COVID-19 combination tests for use at all levels of the U.S. health care system to detect SARS-CoV-2, other respiratory pathogens, and novel or emerging coronaviruses in order to inform appropriate patient management and future pandemic response.

BD (Becton Dickinson and Company) USA

Description:
A molecular test that detects and distinguishes SARS-CoV-2, Influenza A and B, and RSV. This is a high-throughput test for use in core and reference laboratories.

Unique Impact:
The BD contract will develop an integrated suite of FDA-cleared COVID-19 combination tests for use at all levels of the U.S. health care system to detect SARS-CoV-2, other respiratory pathogens, and novel or emerging coronaviruses in order to inform appropriate patient management and future pandemic response.

BD (Becton Dickinson and Company) USA

Description:
A molecular test that detects and distinguishes SARS-CoV-2, Influenza A and B, RSV, SARS-1, MERS, seasonal coronaviruses, and novel or emerging coronaviruses. This is a medium-throughput test for use in acute-care settings.

Unique Impact:
The BD contract will develop an integrated suite of FDA-cleared COVID-19 combination tests for use at all levels of the U.S. health care system to detect SARS-CoV-2, other respiratory pathogens, and novel or emerging coronaviruses in order to inform appropriate patient management and future pandemic response.

BD (Becton Dickinson and Company) USA

Description:
A molecular test that detects and distinguishes SARS-CoV-2, Influenza A and B, RSV, SARS-1, MERS, seasonal coronaviruses, and novel or emerging coronaviruses. This is a high-throughput test for use in core and reference laboratories.

Unique Impact:
The BD contract will develop an integrated suite of FDA-cleared COVID-19 combination tests for use at all levels of the U.S. health care system to detect SARS-CoV-2, other respiratory pathogens, and novel or emerging coronaviruses in order to inform appropriate patient management and future pandemic response.

BD (Becton Dickinson and Company) USA

Description:
An FDA-cleared, rapid antigen test that detects and distinguishes SARS-CoV-2, Influenza A, and Influenza B in point-of-care settings.

Unique Impact:
The BD contract will develop an integrated suite of FDA-cleared COVID-19 combination tests for use at all levels of the U.S. health care system to detect SARS-CoV-2, other respiratory pathogens, and novel or emerging coronaviruses in order to inform appropriate patient management and future pandemic response.

OraSure Technologies, Inc USA

Description:
ELISA based Coronavirus Antibody Test and non-invasive collection device for the detection of anti-SARS-CoV-2 antibodies in oral fluid specimens. Sample collection can be obtained at home, promoting social distancing and reducing risk to health workers.

Unique Impact:
Currently there are no oral fluid based COVID antibody tests available with automated assays. Availability of a non-invasive COVID test will allow a large number of individuals to be screened using self-collection, which makes the OraSure device ideal to reach people in non-professional settings.

Cost Share: Yes

OraSure Technologies, Inc USA

Description:
InteliSwab™ COVID-19 Tests are rapid, antigen tests used at the point-of-care and in-home. Testing is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 30 minutes – with no instruments, batteries, smartphone or laboratory analysis.

Unique Impact:
The OTC home test for use without a prescription in individuals 15 years or older (with or without symptoms) when tested twice over two or three days with at least 24 and no more than 36 hours between tests.

Status: EUA Issued

Cost Share: Yes

OraSure Technologies, Inc USA

Description:
InteliSwab™ COVID-19 Tests are rapid, antigen tests used at the point-of-care and in-home. Testing is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 30 minutes – with no instruments, batteries, smartphone or laboratory analysis.

Unique Impact:
The prescription home test is authorized for prescription home use with self-collection (unobserved) of anterior nasal samples from individuals 18 years or older or adult collected samples from individuals age 15 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven (7) days of symptom onset.

Status: EUA Issued

Cost Share: Yes

OraSure Technologies, Inc USA

Description:
InteliSwab™ COVID-19 Tests are rapid, antigen tests used at the point-of-care and in-home. Testing is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and see their result on the test stick in 30 minutes – with no instruments, batteries, smartphone or laboratory analysis.

Unique Impact:
The Professional Test, which is packaged in bulk configurations, is authorized for use at the point of care in certain healthcare settings, for individuals 15 years or older who are suspected of COVID-19 by their healthcare provider within 7 days of symptom onset or for individuals without symptoms when tested twice over two or three days.

Status: EUA Issued

Cost Share: Yes

Regeneron Pharmaceuticals, Inc USA

Description:
REGEN-COV (casirivimab and imdevimab) is a combination of two monoclonal antibodies that was designed to block infectivity of SARS-CoV-2. Administered for the treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years of age and at least 40 kg), with positive SARS-CoV-2 test results who are at high risk for progression to severe COVID-19, including hospitalization or death.

Unique Impact:
A novel therapeutic antibody cocktail for COVID-19 developed under the existing BARDA Regeneron OTA collaboration, leveraging Regeneron's monoclonal antibody discovery platform called VelocImmune, part of the company's proprietary VelociSuite technology. Due the high frequency of the Omicron variant and subvariants and REGEN-COV’s lack of in vitro activity against them, REGEN-COV is not currently authorized in any U.S. region.

Status: No Longer Authorized

Sanofi Pasteur and GSK USA

Description:
Recombinant SARS-CoV-2 spike protein with transmembrane region deleted produced using Sanofi’s FDA-licensed seasonal influenza vaccine Flublok® facilities, adjuvanted with GSK's AS03

Unique Impact:
Protein Sciences (acquired by Sanofi in 2017) baculovirus expression vector system (BEVS) allows flexibility and scalability, which are cornerstones of rapid response to an emerging infectious disease.

Status: Phase 3

Nexelis USA

Description:
The USG has a need for additional laboratory capacity to analyse serum samples from multiple COVID-19 Phase III vaccine clinical trials. Serum samples are tested to ascertain the ability of the vaccine to induce an immune response. Serological analyses of COVID-19 vaccine trial specimens will be performed by meso scale discovery (MSD)-electrochemiluminescence (ECL) immunoassay that allows for simultaneous measurement of multiple SARS-CoV-2 proteins in the same well. The contractor will test samples to support development of COVID-19 vaccines towards approval.

Cepheid USA

Description:
This test detects viral nucleic acid and differentiates COVID-19, Flu A, and Flu B during the 2020-21 Flu season. The test operates on Cepheid’s widely-placed family of GeneXpert DX, Infinity, and Xpress instruments in both laboratory and point-of-care settings. Cepheid developed this test in partnership with BARDA and the Department of Defense.

Unique Impact:
The test detects and differentiates COVID-19 from Flu in a single sample from an individual with symptoms of respiratory illness, enabling proper patient management and containment of COVID-19 during the 2020-21 Flu season. The test provides results within 25 minutes for SARS-CoV-2 and 36 minutes for influenza positive results.

Status: EUA Issued

Cost Share: Yes

Cepheid USA

Description:
The Xpert Pan-Coronavirus test will detect and differentiate the seven known coronaviruses that infect humans, including SARS-CoV-2, and will detect novel and emerging coronaviruses. The test will operate in laboratory and point-of-care settings on Cepheid’s GeneXpert System.

Unique Impact:
The Xpert Pan-Coronavirus test will enable detection and differentiation of the seven known human coronaviruses. The test will also enable detection of novel and emerging coronaviruses that spill over into the human population that may lead to the next pandemic. Rapid detection of novel and emerging coronaviruses will allow more rapid response to contain the virus and limit potential impact.

Cepheid USA

Description:
The Xpert Xpress SARS-CoV-2 test is a molecular diagnostic that detects viral nucleic acid in respiratory samples. The test operates on Cepheid’s family of GeneXpert DX, Infinity, and Xpress instruments in both laboratory and point-of-care settings. Cepheid developed this test in partnership with BARDA and the Department of Defense.

Unique Impact:
The Xpert Xpress SARS-CoV-2 test operates on the entire family of Cepheid instruments widely placed across the U.S. in laboratories and at the point-of-care. The test provides results in under 30 minutes for positive results.

Status: EUA Issued

Technical Resources International, Inc. (TRI) USA

Description:
BARDA and NCATS will evaluate multiple therapeutic agents for the treatment of moderately or severely ill hospitalized patients infected with SARS-CoV-2 in the ACTIV-1 master protocol. This protocol will study Remicade, Abatacept, and Cenicriviroc as add-on therapies to remdesivir plus the current standard of care (SoC).

LightDeck Diagnostics USA

Description:
The LightDeck® COVID-19 Antigen Test is a high-performance, ultra-rapid point-of-care test to assess infection with the SARS-CoV-2 virus.

Unique Impact:
Development of a rapid point-of-care SARS-CoV-2 antigen test that can detect infection with SARS-CoV-2 in 6 minutes or less, and could allow on-site screening of people in non-clinical settings such as nursing homes, schools, essential workplaces, and other community testing sites.

LightDeck Diagnostics USA

Description:
The LightDeck COVID-19 Total Antibody Test is being developed as a point-of-care test for seroprevalence studies to assess exposure and potential immunity to the SARS-CoV-2 virus.

Unique Impact:
LightDeck’s COVID-19 Total Antibody Test measures total antibody to SARS-CoV-2. This 5 minute test potentially could be used to measure antibody levels in recovered patients for plasma donation in a convenient point-of-care venue.

Cost Share: Yes

ModernaTX, Inc. USA

Description:
FDA-approved mRNA COVID-19 vaccine that is indicated for active immunization to prevent COVID-19 in individuals 18 years of age or older.

Unique Impact:
Spikevax is the second fully approved COVID-19 vaccine. FDA-approved Spikevax (COVID-19 Vaccine, mRNA) and the EUA-authorized Moderna COVID-19 vaccine have the same formulation and can be used interchangeably.

Status: Licensed

Dascena Inc. USA

Description:
Dascena’s EUA-approved COViage™ software is a machine learning algorithm that analyzes patient data from electronic health records (EHR) systems and gives the healthcare professional advanced notification of COVID-19 patients at risk for unstable blood pressure or respiratory decline requiring ventilation.

Unique Impact:
COViage™, an EUA authorized machine learning algorithm can provide early warning of potential critical conditions in COVID-19 patients, enabling escalated care to improve patient management and outcomes. This effort will further support 510(k) regulatory activities and demonstrate scalable deployment and implement of infection of severity algorithms during a pandemic.

Status: EUA Issued

Cost Share: Yes

DiaSorin Inc. USA

Description:
LIAISON SARS-CoV-2 TrimericS IgG assay is a chemiluminescent immunoassay for the semiquantitative detection of the IgG class of antibodies against SARS-CoV-2, the virus that causes COVID-19 disease, in serum and plasma specimens.

Unique Impact:
LIAISON SARS-CoV-2 TrimericS IgG assay is being developed to overcome the limitations of the existing EUA LIAISON SARS-CoV-2 S1/S2 IgG assay to assist with determining exposure and immune status.

Status: EUA Issued

DiaSorin Inc. USA

Description:
An enhanced serology test to detect IgM antibodies against SARS-CoV-2 in human serum or plasma, using chemiluminescent immunoassay technology on the fully automated LIAISON® XL platform.

Unique Impact:
DiaSorin's serology test detects IgM antibodies against SARS-CoV-2 in human serum or plasma, using chemiluminescent immunoassay technology on the fully automated LIAISON XL platform to assist with monitoring the immune status of individuals.

Status: EUA Issued

Cost Share: Yes

DiaSorin Inc. USA

Description:
Serology (antibody) test for COVID-19 on the LIAISON XL platform. This new COVID-19 test is a fully automated, chemiluminescent immunoassay for the qualitative detection of IgG class antibodies against the SARS-CoV-2 virus.

Unique Impact:
Serology test for COVID-19 on the LIAISON XL platform. This COVID-19 test is a fully automated, chemiluminescent immunoassay for the qualitative detection of IgG antibodies that respond to the SARS-CoV-2 virus. This test will assist to identify and monitor the immune status of individuals response to SARS-CoV-2.

Status: EUA Issued

Cost Share: Yes

Boca Biolistics USA

Description:
Boca Biolistics will provide aliquots of serum or plasma that have been collected from people exposed to novel SARS-CoV-2 variants, in order to support nonclinical testing to better understand the impact of SARS-CoV-2 mutations against medical countermeasure efficacy. The samples are derived from Boca Biolistics’ inventory of clinical samples, which were collected from SARS-CoV-2-exposed individuals from a wide geographic distribution. The viral variants of exposure have been confirmed by Next Generation Sequencing (NGS), the data of which will be provided alongside the samples.

San Diego Blood Bank USA

Description:
San Diego Blood Bank will collect plasma from subjects who have not been infected with the SARS-CoV-2 virus and who have been vaccinated with COVID-19 vaccines that have been made available for distribution under EUA. This plasma, alongside key subject data will be used to support a newly-established interagency COVID-19 serum biorepository.

AgileMD USA

Description:
eCART is a clinical decision support (CDS) tool that combines a real-time, machine learning algorithm with electronic health record data to identify the need for mechanical ventilation or hemodynamic support for COVID-19 patients.

Unique Impact:
Successful deployment of this CDS will help save COVID-19 patient lives and reduce patient costs by reducing the need and duration for mechanical ventilation or hemodynamic support in critically ill patients.

Cost Share: Yes

Siemens Healthineers USA

Description:
The SARS-CoV-2 Antigen (CoV2Ag) test is a chemiluminescent immunoassay intended for qualitative detection of SARS-CoV-2 viral antigens in nasal swabs and saliva using the ADVIA Centaur® XP and XPT systems.

Unique Impact:
Siemens has over 2,000 fully automated immunoassay analyzers in hospitals and mid-to-high volume reference laboratories across all 50 states. These analyzers include the ADVIA Centaur® XP & XPT, which can test up to 240 samples/hour with a result in 18 minutes.

Siemens Healthineers USA

Description:
The SARS-CoV-2 Antigen (CoV2Ag) test is a chemiluminescent immunoassay intended for qualitative detection of SARS-CoV-2 viral antigens in nasal swabs and saliva using the Atellica® IM platforms.

Unique Impact:
Siemens has over 2,000 fully automated immunoassay analyzers in hospitals and mid-to-high volume reference laboratories across all 50 states. These analyzers include the Atellica® IM, which can run up to 440 tests/hour with a result in 10 minutes.

Siemens Healthineers USA

Description:
The SARS-CoV-2 Total (COV2T) is a chemiluminescent immunoassay intended for the semi-quantitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 virus in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM platforms.

Unique Impact:
Siemens has over 2,000 fully automated immunoassay analyzers in hospitals and mid-to-high volume reference laboratories across all 50 states. The analyzers include the Atellica® IM, which can run up to 440 tests/hour with result in 10 minutes.

Status: EUA Issued

QuidelOrtho Corporation USA

Description:
The VITROS® SARS-CoV-2 Antigen test is intended for the in vitro qualitative detection of antigen from SARS-CoV-2 in nasopharyngeal (NP) swabs from individuals with known or suspected exposure to SARS-CoV-2, or who are displaying symptoms suggestive of viral infection.

Unique Impact:
The antigen tests are run on the high-throughput, random access, fully automated VITROS® Systems. Ortho Clinical Diagnostics has already installed these analyzers in more than 1,000 hospitals and labs across the U.S. VITROS® Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.

Status: EUA Issued

QuidelOrtho Corporation USA

Description:
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG (VITROS Anti-SARS-CoV-2 IgG) test is a chemiluminescent immunoassay test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Unique Impact:
The VITROS Anti-SARS-CoV-2 IgG test is the first in vitro diagnostic COVID-19 antibody assay for the qualitative detection of IgG SARS-CoV-2 antibodies in human blood to be granted De Novo classification by the U.S. FDA. The test can assess immune response to SARS-CoV-2 over time, which can help researchers, healthcare workers, and patients understand and manage this disease.

Status: Cleared

QuidelOrtho Corporation USA

Description:
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Test (VITROS Anti-SARS-CoV-2 Total) is a chemiluminescent immunoassay intended for the qualitative detection of total SARS-CoV-2 antibodies in human serum and plasma (K2-EDTA, K3-EDTA and lithium heparin) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Unique Impact:
The VITROS Anti-SARS-CoV-2 Total test is the first in vitro diagnostic COVID-19 antibody assay for the qualitative detection of total SARS-CoV-2 antibodies in human blood to be granted De Novo classification by the U.S. FDA. The test can assess immune response to SARS-CoV-2 over time, which can help researchers, healthcare workers, and patients understand and manage this disease.

Status: Cleared

Siemens Healthineers USA

Description:
The SARS-CoV-2 Total (COV2T) is a chemiluminescent immunoassay intended for the semi-quantitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 virus in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP and XPT systems.

Unique Impact:
Siemens has over 2,000 fully automated immunoassay analyzers in hospitals and mid-to-high volume reference laboratories across all 50 states. These analyzers include the ADVIA Centaur® XP & XPT analyzers, which can test up to 240 samples/hour with result in 18 minutes.

Status: EUA Issued

PeraHealth Inc. USA

Description:
The Rothman Index Risk Triage Tool, a mobile and desktop application for use in the Emergency Department, leverages the FDA-cleared Rothman Index, a machine-learning derived algorithm that provides physicians an estimate of health deterioration and mortality risk. The application will aid in the triage and admission of general medical patients as well as patients with suspected or confirmed COVID-19.

Unique Impact:
The Rothman Index Risk Triage Tool will rapidly assess patient risk for deterioration or mortality to aid hospital admission triage and improve clinical management. This effort will explore the end-user feedback from implementation and demonstrate scaling readiness. In addition, a version of the app will be developed as a non-COVID-19 triage tool for continued, post-pandemic impact.

Cost Share: Yes

Janssen Pharmaceuticals, Inc. USA

Description:
Support development to licensure of a vaccine to combat COVID-19 using Janssen’s established Adenovirus 26 platform, plus demonstration of Janssen's capacity to perform large scale manufacturing domestically of up to 100 million doses of its SARS-CoV-2 vaccine, Ad26.COV2.S

Unique Impact:
Janssen has significant nonclinical and clinical experience and investment in the Ad26-based vaccine technology platform and will have significant domestic and global vaccine manufacturing capability, to maximize the probability of a successful vaccine and rapid deployment within the US and globally.

Updates:
Successful development of the prototype will demonstrate Janssen’s ability to rapidly stand up and seamlessly transition to large scale manufacturing to meet surge requirements, and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed under EUA or FDA licensure.

Status: EUA Issued

DiaSorin SpA Italy

Description:
DiaSorin intends to develop, validate, manufacture, market, and obtain regulatory authorization in the United States and worldwide for a new, fully automated, chemiluminescent, immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasal swab or nasopharyngeal swab.

Unique Impact:
The LIAISON SARS-CoV-2 antigen assay will overcome the limitations of existing assays with regards to ease of sample collection by expanding the types of samples that can be tested for diagnosis of acute COVID-19 disease.

Status: EUA Issued

The Broad Institute USA

Description:
The Broad Institute is testing samples to understand how much antibody is in each unit of convalescent plasma being given to patients in the Mayo Clinic Expanded Access Program. Antibodies are believed to be the therapeutic component of plasma, by direct viral targeting.

Luminex Corporation USA

Description:
Luminex Corporation is developing a new sample-to-answer ARIES® Flu A/B & RSV+SARS-CoV-2 panel for the detection of respiratory pathogens from nasopharyngeal swabs. It will be based on TaqMan chemistry and offer independent results for all four (4) targets on the panel.

Unique Impact:
Combining assays for Flu A/Flu B/RSV and SARS-CoV-2 into a single panel will allow health care providers to distinguish SARS-CoV-2 from other common respiratory pathogens and facilitate proper treatment

Luminex Corporation USA

Description:
NxTAG® Respiratory Pathogen Panel v2 + SARS-CoV-2, for use on the Luminex MAGPIX® instrument, is a multiplex RT-PCR test intended for the simultaneous detection and differentiation of nucleic acid from multiple viral and bacterial respiratory organisms, in nasopharyngeal swabs.

Unique Impact:
NxTAG® Respiratory Pathogen Panel v2 + SARS-CoV-2, is a molecular multiplex test offerings detection of 19 viral pathogens in a single well, enabling thorough respiratory health analysis. 96 samples can be processed in less then 3 hours post-extraction in the laboratory.

Luminex Corporation USA

Description:
Luminex is modifying the xMAP® SARS-CoV-2 Multi-Antigen IgG test, which is a multiplex, microsphere-based, highly sensitive and specific assay to provide a comprehensive view of neutralizing antibody response.

Unique Impact:
The assay uses three different viral antigens to detect antibodies associated with prior infection or vaccination to SARS-CoV-2. It also provides an assessment of antibody neutralizing activity– providing more actionable results. This new high-throughput assay adds advanced serology testing capability using equipment already installed in US healthcare facilities.

Cost Share: Yes

Luminex Corporation USA

Description:
The ARIES® SARS-CoV-2 assay is a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease, in respiratory specimens. This assay is developed for use on Luminex IVD ARIES® molecular diagnostic system.

Unique Impact:
The ARIES® SARS-CoV-2 assay is developed for use on the Luminex IVD ARIES system, which is a fully automated, high-throughput molecular diagnostic platform with over 300 instruments installed in the U.S.

Status: EUA Issued

Cost Share: Yes

Luminex Corporation USA

Description:
The NxTAG® CoV Extended Panel, for use on Luminex’s MAGPIX® instrument, is a RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider.

Unique Impact:
The NxTAG® CoV Extended Panel is a molecular lab test that supports the high-throughput detection of SARS‑CoV‑2 in nasopharyngeal swab (NPS) samples. The NxTAG CoV panel detects three separate gene targets to ensure accurate, reliable results.

Status: EUA Issued

Cost Share: Yes

Cantor BioConnect USA

Description:
Purchase of convalescent Serum for Serological Testing.

Visby Medical Inc. USA

Description:
The Visby Medical Flu & COVID-19 Personal PCR test is a single-use, all-in-one test that fits in the palm of your hand. It has a fast sample-to-result time of <30min and can detect and distinguish between Influenza A and B, and SARS-CoV-2.

Unique Impact:
This diagnostic test funded by BARDA will expand on Visby’s COVID-19 test, which already received EUA under RADx support, to develop a multiplexed Flu A, Flu B and COVID-19 respiratory test through EUA and ultimately 510(k) clearance. The test requires no additional instrument and is designed for both Point-of-Care and Over-the-Counter use.

Status: EUA Issued

Cost Share: Yes

Battelle Memorial Institute USA

Description:
Battelle Memorial Institute will provide high-throughput SARS-CoV-2 assay development and testing of human serum samples, in order to support USG need for additional laboratory capacity to analyse serum samples from multiple COVID-19 Phase III vaccine clinical trials. Contract options will enable testing of serum samples using a SARS-CoV-2 Spike pseudotyped virus-neutralization (VN) assay. Sample testing results will support the development of COVID-19 vaccines towards regulatory approval.

Coram/CVS Specialty Infusion Services USA

Description:
As part of the Interagency COVID-19 Response team, Coram/CVS will conduct a pilot program to administer 1000 doses of Bamlanivimab to COVID-19 positive patients under the product’s current EUA. This allows home infusion of patients with mild/moderate disease severity who are at high-risk of hospitalization to help prevent disease progress and additional strain on hospitals.

Hologic, Inc. USA

Description:
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A virus (Flu A), influenza B virus (Flu B), and RSV. Nucleic acids are isolated and purified from nasopharyngeal (NP) specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. The Hologic® RespDirect™ Collection Kit is intended to be used for the collection of NP swab specimens (collected by a healthcare professional) for testing with Hologic respiratory assays that are indicated/cleared for use with the RespDirect Collection Kit.

Unique Impact:
This assay detects and differentiates SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV), which exhibit similar symptoms. The test aids clinicians in determining which virus patients have to make more informed decisions about treatment. The Hologic RespDirect Collection Kit enables labs to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, saving time, reducing potential for error, exposure to viruses, and more.

Status: Cleared

Hologic, Inc. USA

Description:
The Aptima SARS-CoV-2/Flu assay is used for simultaneous detection and differentiation of RNA from the SARS-CoV-2, influenza A and influenza B viruses from a single sample.

Unique Impact:
The Aptima® SARS-CoV-2/Flu Assay runs on Hologic’s fully automated Panther® Systems, which can provide initial results in approximately three hours and process more than 1,000 tests in 24 hours.

Status: EUA Issued

Hologic, Inc. USA

Description:
The Aptima® SARS-CoV-2 assay is a molecular in vitro diagnostic test that detect SARS-CoV-2, the virus that causes COVID-19 disease, in respiratory specimens.

Unique Impact:
Aptima® SARS-CoV-2 assay is being developed for use on the Hologic Panther® System which is a fully automated, high-throughput molecular diagnostic platform with over 1,100 instruments installed in the U.S.

Status: EUA Issued

Hologic, Inc. USA

Description:
The Panther Fusion® SARS-CoV-2 assay is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 virus in respiratory specimens.

Unique Impact:
The Panther Fusion® SARS-CoV-2 assay runs on the Panther Fusion Systems. This molecular diagnostic platform can process 1,000 tests in 24 hours and can deliver test results in 3 hours, greatly expanding US capacity to detect the SARS-CoV-2 virus.

Status: EUA Issued

America's Blood Centers USA

Description:
Collection of convalescent plasma for potential therapeutic use in COVID-19 illness.

American Red Cross USA

Description:
Collection of convalescent plasma for potential therapeutic use in COVID-19 illness.

DiaSorin Molecular LLC USA

Description:
The DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct is a real-time RT-PCR assay intended for use on the LIAISON MDX instrument for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus in nasopharyngeal swabs (NPS) from individuals with signs and symptoms of respiratory tract infection. The Simplexa COVID-19 & Flu A/B Direct assay is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A and influenza B infection. The Simplexa COVID-19 & Flu A/B Direct assay is intended for use by qualified & trained clinical laboratory personnel specifically instructed & trained in the techniques of real-time PCR & in vitro diagnostic procedures.

Unique Impact:
Respiratory infections can often present similar symptoms. The DiaSorin Molecular Simplexa COVID-19 & Flu A/B Direct real-time RT-PCR assay can aid in distinguishing between respiratory infections. Adaptable, highly sensitive and specific diagnostic testing technologies are needed to quickly detect the respiratory pathogen, inform earlier treatment, improve equitable diagnostic access, reduce burdens on the health care system, and help mitigate the impacts of outbreaks.

Status: Cleared

DiaSorin Molecular LLC USA

Description:
The LIAISON® MDX real time PCR platform is a fully automated sample to answer system that can be used for random access testing, with a throughput capacity of up to 96 samples per hour. The platforms have been placed in the US and globally, including multiple placements in hospitals and large reference laboratories.

Unique Impact:
To date, the COVID-19 pandemic has caused more than half a billion cases worldwide and over six million deaths, according to the World Health Organization. It is important to ensure COVID-19 testing capacity at hospitals and commercial facilities across the nation after the FDA Emergency Use Authorization period has ended, to maintain vigilance post-pandemic against SARS-CoV-2 infections. The Simplexa™ COVID-19 Direct assay will ensure a high standard of diagnostic testing in order to help mitigate future potential impacts of this virus.

Status: Cleared

Cost Share: Yes

Chembio Diagnostics Inc. USA

Description:
The DPP Respiratory Antigen Panel test simultaneously detects and differentiates viral antigens of Influenza A, Influenza B, and SARS-CoV-2 in respiratory samples. If approved, this test could provide results within 20 minutes at the point-of-care.

Unique Impact:
The DPP Respiratory Antigen Panel test rapidly detects and differentiates flu from COVID-19 in individuals with symptoms of respiratory illness. This test enables timely patient management and containment of COVID-19, especially in decentralized environments.

Chembio Diagnostics Inc. USA

Description:
The Dual Path Platform (DPP) SARS-CoV-2 Antigen test detects viral antigen in respiratory samples. The test is based on Chembio’s patented lateral-flow-based DPP technology and DPP Micro Reader that are cleared for use with other infectious diseases.

Unique Impact:
The DPP SARS-CoV-2 Antigen test is an easy-to-use, rapid test that provides results in approximately 20 minutes. The test can enable rapid screening of individuals with symptoms of COVID-19 at the point-of-care.

Cost Share: Yes

Quantum Leap Healthcare Collaborative USA

Description:
The Quantum Leap Heathcare Collaborative (QLHC) platform trial accelerates clinical evaluation of COVID-19 therapeutic agents in hospitalized patients. The prototype demonstration includes expansion of the study to include additional sites and testing of up to 10 agents selected in collaboration between QLHC and USG.

Controlant Global Iceland

Description:
Controlant will provide real-time vaccine temperature monitoring services for Pfizer’s COVID-19 Vaccine. In the event of a temperature excursion while the vaccine is en route or at the jurisdiction sites, Controlant will alert and provide additional instructions to users at the individual sites.

PPD Development LP USA

Description:
The USG has a need for additional laboratory capacity to analyze serum samples from multiple COVID-19 Phase III vaccine clinical trials. Serum samples will be tested using an assay developed by the Interagency COVID-19 Response team's supported laboratories with reagent kits sourced from Meso Scale Discovery (MSD). The assay will be transferred to PPD and the contractor will test samples to support development of COVID-19 vaccines towards regulatory approval.

Mesa Biotech, Inc. USA

Description:
The Accula® Flu/SARS-CoV-2 Integrated Test will provide molecular test results in approximately 30 minutes. It will use the same Accula® instrument already FDA 510(k) cleared and in use for FDA 510(k) cleared and CLIA-waived Accula® Flu A/Flu B tests as well as the FDA EUA CLIA-waived Accula® SARS-CoV-2 test.

Unique Impact:
Combining assays for Flu A/Flu B and SARS-CoV-2 into a single 30 minute test, and with over 3900 Accula® docks installed nation-wide, will allow health care providers to rapidly distinguish influenza from SARS-CoV-2 and facilitate proper treatment.

Mesa Biotech, Inc. USA

Description:
Development of the Accula COVID-19 point-of-care test to request Emergency Use Authorization (EUA) from the FDA within two months of the award.

Unique Impact:
The Accula COVID-19 test is a rapid molecular (RT-PCR), visually-read test that detects SARS-CoV-2 RNA in combined throat and nasal swab samples in 30 minutes. Platform is small, portable, and battery-operated and is suitable for use in point-of-care settings.

Status: EUA Issued

Cost Share: Yes

Humanigen USA

Description:
Lenzilumab is a Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19. BARDA will provide technical assistance on a Phase 3 clinical trial underway.

Unique Impact:
Lenzilumab has the potential to reduce hospital stays and the need for ventilators due to COVID-19 disease.

Status: Phase 3

InBios International, Inc. USA

Description:
SCoV-2 Ab Detect™ Rapid Test, is a lateral flow serodiagnostic test that uses fingerprick blood, to identify persons with SARS-CoV-2. This point-of-care assay will detect SARS-CoV-2 reactive antibodies as host biomarkers.

Unique Impact:
Funding will be used for the development of a rapid point-of-care SARS-CoV-2 antibody test that can detect infection with SARS-CoV-2 allowing fast screening of people in non-clinical settings.

Status: EUA Issued

Cost Share: Yes

InBios International, Inc. USA

Description:
SCoV-2 Ag Detect Rapid Test is a lateral flow immunoassay that uses direct nasal swab specimens to detect SARS-COV-2 antigen. This point-of-care assay is simple to use and provides results in less than 30 minutes.

Unique Impact:
This test has received EUA for qualitative detection of SARS-CoV-2 Nucleoprotein from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Status: EUA Issued

AstraZeneca USA

Description:
The AZD1222 vaccine consists of the replication-deficient simian adenovirus vector ChAdOx1, containing the structural surface glycoprotein (Spike protein) antigen of the SARS CoV-2 (nCoV-19)

Unique Impact:
The late stage clinical testing of the vaccine candidate in parallel with developing large scale manufacturing is intended to help enable the Operation Warp Speed goal of making doses available by the end of 2020 and additional doses by the end of 1Q2021.

Status: Phase 3

Cost Share: Yes

Labcorp's Monogram Biosciences Inc. USA

Description:
Labcorp’s Monogram Biosciences Inc., will provide high-throughput SARS-CoV-2 assay development and testing of human serum samples, in order to support USG need for additional laboratory capacity to analyse serum samples from multiple COVID-19 Phase III vaccine clinical trials. Serum samples will be tested using a SARS-CoV-2 Spike pseudotyped virus-neutralization assay (VN test). Sample testing will support the development of COVID-19 vaccines towards approval.

Beckman Coulter USA

Description:
Beckman Coulter seeks to validate its existing FDA cleared Monocyte Distribution Width (MDW) hematology-based biomarker, currently used to detect adult sepsis,for rapid detection of MIS-C, a severe COVID-19 complication in children.

Unique Impact:
The detection of MIS-C is complex and time-consuming. Current laboratory tests are non-specific, and no MIS-C diagnostic assay exists. This work will support validation of MDW to detect MIS-C, a COVID-19 complication in children by expanding the indication of a FDA cleared sepsis detection biomarker.

Cost Share: Yes

Current Health Scotland

Description:
A FDA-cleared Artificial Intelligence-powered continuous remote patient monitoring platform that utilizes a wearable vital-signs sensor, integrates with other devices and includes symptom chatbot and video visit functionality. The platform continuously collects respiratory rate, oxygen saturation, mobility, pulse rate and body temperature data.

Unique Impact:
Current Health’s platform gives healthcare providers the ability to monitor and manage their patients’ health. Through the establishment of digital biomarker-based algorithms to monitor COVID-19 patients, the platform is expected to detect deterioration of health and predict disease severity to include the need for hospitalization and ICU-level support.

Cost Share: Yes

98point6 USA

Description:
The 98point6 primary care platform combines a telehealth service with AI and machine learning to provide a comprehensive program of diagnosis, assessment, triage, reporting and tracking of SARS-CoV-2 infections to a national population of patients.

Unique Impact:
The ability to assess data daily across a national population allows real-time comparison of geographic patterns of infection. By combining ease of access and little to no cost per visit, 98point6 encourages patients to seek care at the earliest stages of illness.

Cost Share: Yes

NOWDiagnostics Inc. USA

Description:
The ADEXUSDx® COVID-19 serology test is a rapid point-of-care lateral flow assay for detection of antibodies to SARS-CoV-2 in blood that utilizes the NOWDiagnostics® ADEXUSDx® device platform. This platform is already commercialized for other tests, including an FDA cleared professional use pregnancy test that is CE marked for self-testing.

Unique Impact:
The ADEXUSDx® device platform allows direct application of a finger stick blood sample from the lance site to the test device without the need of an intermediate sample transfer step; removing the need for additional supplies that may be in short supply. The samples do not have to be sent to an off-site laboratory for analysis.

Status: EUA Issued

Cost Share: Yes

University of Connecticut USA

Description:
An easy-to-use vaccine-delivery microneedle (MN) patch (i.e., Micro Array Patch) that will contain the spike protein (the S-protein on the shell of COVID-19 virus) and be programmed to automatically deliver this S-protein (as an antigen against COVID-19) into the skin.

Unique Impact:
This technology has the potential for mass distribution of self-administered immunizations that rival or potentially surpass the effectiveness of an immunization delivered via traditional needle and syringe.

Cost Share: Yes

Vaxess Technologies, Inc. USA

Description:
MIMIX Vaccine Patch Development and Scaling of shelf-stable, self-applied, single-dose Micro Array Patch (MAP) technology

Unique Impact:
This technology could open the profound potential for large-scale distribution of self-administered immunizations that rival or potentially surpass the effectiveness of an immunization delivered via traditional needle and syringe.

Cost Share: Yes

Mt. Sinai USA

Description:
Mt Sinai is studying the amount of antibody or “titer” in plasma present in convalescent plasma being used in the Mayo Clinic expanded access protocol. Antibodies are believed to be the therapeutic component of plasma, by direct viral targeting.

Esperovax, Inc. USA

Description:
An oral immunization for COVID-19 involving delivery of enveloped virus like particles (eVLPs) by capsule to the gut that will induce immune protection against disease.

Unique Impact:
This technology aims to provide a cost-effective technological innovation that improves immunization uptake, coverage, compliance and preparedness, with the potential for self-administration

Cost Share: Yes

Verndari, Inc. USA

Description:
SARS-CoV-2 Recombinant Spike Receptor Binding Domain protein administered via Micro Array Patch (MAP) Technology

Unique Impact:
This technology aims to provide a cost-effective technological innovation that improves immunization uptake, coverage, compliance and preparedness, with the potential for self-administration.

Cost Share: Yes

Novavax Inc. USA

Description:
Manufacture and delivery of SARS-CoV-2 vaccine doses, NVX-CoV2373, which is suitable for use in humans under a sufficiently informed deployment strategy, and the advanced positioning of a stockpile of critical long lead raw materials for the Matrix-M adjuvant. The NVX-CoV-2373 vaccine is comprised of the Matrix-M™ adjuvant, and antigen (SARS-CoV-2 spike protein).

Unique Impact:
Successful development of the prototype will demonstrate Novavax’s ability to rapidly stand up and seamlessly transition to large scale manufacturing to meet surge requirements, and demonstrate capability to stockpile and distribute large quantities of the vaccine to respond when needed under EUA or FDA licensure.

Status: Phase 3

Sonica Health USA

Description:
Sonica Health developed the ADAM Monitoring System for COVID-19. The soft, conformable, wireless device softly adheres to the suprasternal notch at the base of the throat for continuous monitoring. This project establishes the sensor’s ability to identify early respiratory infections, including COVID-19, in a high-risk clinical population.

Unique Impact:
Individuals infected with SARS-CoV-2 and similar viruses typically only seek diagnostic tests once they begin exhibiting symptoms. Sonica aims to disrupt this health-care paradigm by detecting infection in individuals before the onset of noticeable symptoms.

Cost Share: Yes

Empatica, Inc. USA

Description:
Aura is an early warning platform for COVID-19 infection. This diagnostics platform enables continuous and real-time insight into infection likelihood before symptoms present, through the use of a wearable device and an algorithm that can continuously monitor physiological health markers and produce an output.

Unique Impact:
Individuals infected with SARS-CoV-2 and similar viruses usually seek diagnostic tests once they begin exhibiting symptoms, often after an infected person is contagious. Empatica aims to prevent spread by detecting infection in individuals before the onset of symptoms, allowing early intervention through self-quarantine, treatment, and care.

Cost Share: Yes

Immunexpress Inc. USA

Description:
SeptiCyte® RAPID is a host response gene expression, blood-based diagnostic for rapid identification of sepsis that will be evaluated to triage COVID-19 patients for severe outcomes (sepsis) in the ICU and ED. Septicyte Rapid is currently seeking 510(k) clearance but will be further validated for use for COVID-19 patients with viral sepsis.

Unique Impact:
A diagnostic tool, such as SeptiCyte RAPID, can aid in triaging COVID-19 for severe disease outcomes, sepsis. This can assist healthcare providers in determining which patients as identified in the ED and ICU need escalated care for earlier clinical intervention to improve patient outcomes as well as aid in allocating resources.

Cost Share: Yes

Sepsis Alliance USA

Description:
The Sepsis Institute provides educational content to support healthcare providers in the recognition and management of sepsis along the entire continuum of care. Two new webinars will provide sepsis education for healthcare providers caring for COVID-19 patients

Unique Impact:
These webinars will provide educational content to connect messaging that any infectious disease, like that caused by SARS-CoV2 can lead to sepsis and information about COVID-19 sepsis survivors.

Quidel Corporation USA

Description:
Quidel is developing a multiplex viral antigen assay for detection of SARS-CoV-2, RSV, Flu A and Flu B on the Quidel Sofia 2 point-of-care platform.

Unique Impact:
Development of a SARS-CoV-2 antigen detection assay integrated into an existing, widely distributed, multiplex platform for detection of RSV, Flu A and Flu B will be used to detect SARS-CoV-2 infections and discriminate it from other common viral respiratory infections.

Cost Share: Yes

Genentech USA, Inc. USA

Description:
Tocilizumab is a recombinant anti-human monoclonal antibody directed against the interleukin-6 receptor (IL-6R), an important component of the immune response.

Unique Impact:
Tocilizumab acts by blocking the IL-6 receptor and preventing an inflammatory cascade that can lead to severe disease, including in COVID-19. Reducing IL-6 signaling is hypothesized to decrease the duration and/or severity of COVID-19.

Status: Approved

Cost Share: Yes

VitalConnect USA

Description:
Vista Solution is an FDA cleared remote patient monitoring system for use within hospital, nursing home facilities, and homes. Vista Solution is comprised of the VitalPatch biosensor, a tablet where vital signs are viewed and transmitted to a central cloud, a secure cloud, and a central monitoring hub.

Unique Impact:
Vista Solution is used to monitor and care for patients with COVID-19 as well as at-risk nursing home patients to provide an early indication of patient deterioration prior to a patient becoming clinically symptomatic. Changes in heart rate, respiratory rate, blood oxygen saturation, and QT interval changes will be monitored.

Cost Share: Yes

Beckman Coulter USA

Description:
Beckman Coulter, in collaboration with Dascena, Inc., is developing a novel machine-learning-based sepsis detection algorithm for regulatory clearance that combines laboratory test parameter values with electronic health record information to accurately predict and detect sepsis earlier.

Unique Impact:
As part of the partnership with BARDA’s Solving Sepsis program, Beckman Coulter and Dascena will conduct clinical studies for validation of the sepsis prediction algorithm, including studies that enrich for COVID-19 patient subpopulations to ensure that the algorithm is trained and optimized for detecting viral-induced causes of sepsis.

Cost Share: Yes

American Type Culture Collection USA

Description:
COVID-19 Biological Specimen and Investigational Product Storage Facility (BSIP): These services will expedite and facilitate short-term-storage and processing of clinical samples from COVID-19 patients with associated meta-data.

Cerus Corporation USA

Description:
The Cerus INTERCEPT Blood System reduces the risk of transfusion-transmitted infections from bacteria and other blood-borne pathogens

Unique Impact:
INTERCEPT Blood System is already approved to reduce pathogens in plasma and platelets. This addition will test INTERCEPT Blood System against SARS-CoV-2.

Applied Research Associates, Inc. USA

Description:
Filter media purchase for EN-95 S Reusable Re-usable Mask: The media purchased from this contract will produce 30k production prototypes of a novel reusable EN-95S (Half Elastomeric-half N95).

Evidation Health USA

Description:
Evidation seeks to develop a model that can detect whether an individual has likely been infected with COVID-19 and understand an individual’s susceptibility to infection.

Unique Impact:
This effort will track the infection of COVID-19 in high risk individuals and healthcare workers in order to develop an “early warning algorithm” for symptoms of COVID-19 as well as conduct a pilot study for a large-scale COVID19 sentinel network in the US.

Cost Share: Yes

Veterans Medical Research Foundation of San Diego USA

Description:
UCSD will provide clinical samples from convalescent COVID-19 patients to BARDA and its interagency partners to support serological testing.

Tangen Biosciences USA

Description:
Development of a Point of Care SARS-CoV-2 Assay for use with the Tangen GeneSpark Molecular diagnostic system

Unique Impact:
Development of a SARS-CoV-2 detection Assay from clinical respiratory specimens that is quickly deployed and implemented

Cost Share: Yes

ICON Government and Public Health Solutions USA

Description:
ICON will provide clinical samples from convalescent COVID-19 patients to BARDA and its interagency partners to support serological testing.

Cytovale Inc. USA

Description:
Cytovale’s rapid sepsis diagnostic leverages advances in microfluidics, ultra-high speed imaging, and machine learning to rapidly quantify immune cell dysregulation from a blood sample in minutes to predict the likelihood of sepsis.

Unique Impact:
As part of the partnership through BARDA’s Solving Sepsis program for the advanced development of Cytovale’s rapid sepsis diagnostic, the company will perform a pre-analytical and pre-clinical pilot validation of the sepsis diagnostic at emergency department sites with patients suspected of respiratory infections including SARS-CoV-2.

Cost Share: Yes

Nanomix USA

Description:
The Nanomix eLab® COVID-19 Rapid IgG/IgM Antibody Panel is a rapid mobile test to diagnose either present or past COVID-19 infection by detecting IgG and IgM antibodies in blood samples. This assay is being developed for use on the Nanomix eLab® Analyzer.

Unique Impact:
The Nanomix eLab® COVID-19 Rapid IgG/IgM Antibody Panel enables health care providers to test a patient for evidence of current or past infection in as little as 15 minutes. The test is designed for near-patient locations such as hospitals, long-term care facilities, urgent care centers, and doctor’s offices.

Cost Share: Yes

Nanomix USA

Description:
The Nanomix COVID-19 Rapid Antigen Panel is a rapid mobile test to diagnose COVID-19 infections from nasal and throat swabs. This assay detecting SARS-CoV-2 antigen is being developed for use on the Nanomix eLab® Analyzer.

Unique Impact:
The Nanomix COVID-19 Rapid Antigen Panel enables health care providers to test a patient for early evidence of infection in as little as 15 minutes. The test is designed for near-patient locations such as hospitals, long-term care facilities, urgent care centers, and doctor’s offices.

Cost Share: Yes

Vela Diagnostics USA, Inc. USA

Description:
Probe-based reverse transcriptase PCR (RT-PCR) test

Unique Impact:
The ViroKey test is conducted through nasopharyngeal and oropharyngeal swabs. The manual version of this test enables flexible sample processing and quick adoption of the test by all laboratories with existing ABI 7500 Fast Dx instruments

Status: EUA Issued

Cost Share: Yes

Vela Diagnostics USA, Inc. USA

Description:
Probe-based reverse transcriptase PCR (RT-PCR) test

Unique Impact:
The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of Vela Diagnostics' Sentosa® SX101 and the Sentosa® SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run, with reduced hands-on time.

Status: EUA Issued

Cost Share: Yes

New York University Langone Health – Vaccine Research Center USA

Description:
NYU will provide clinical samples from COVID-19 patients (acute and convalescent) to BARDA and its industry partners to support the development of medical countermeasures for COVID-19.

GenMark Diagnostics, Inc. USA

Description:
The Respiratory Pathogen v2 (RP2) Panel diagnostic test is an expanded version of GenMarks’s FDA cleared ePlex Respiratory Pathogen (RP) Panel and includes assays for the simultaneous detection of SARS-CoV-2 and other respiratory pathogens from nasopharyngeal swabs.

Unique Impact:
BARDA's cost-share funding allowed GenMark to rapidly develop the in-vitro diagnostic RP2 test and receive EUA for use on ePlex® machines in hospitals and clinics across the US. This new GenMark RP2 test merged their FDA cleared ePlex Respiratory Pathogen (RP) Panel test with their SARS-CoV-2 specific test, which previously received EUA.

Status: EUA Issued

Cost Share: Yes

Qiagen, LLC USA

Description:
The test is designed to detect the virus that causes COVID-19 in addition to 20 other pathogens that cause respiratory infections in respiratory specimens.

Unique Impact:
This test is a multiplexed nucleic acid real-time PCR test intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus. This lab-based test uses nasopharyngeal swabs (NPS) collected from patients suspected of COVID-19 by their healthcare provider.

Status: EUA Issued

Janssen Research & Development, LLC USA

Description:
Janssen, in collaboration with Rega Institute of Medical Research, will screen libraries to identify therapeutic compounds with antiviral activity against 2019-nCoV.

Unique Impact:
Library screening of compounds with some safety and clinical trial data, to accelerate evaluation of potential candidates that may contribute to providing immediate relief to the current outbreak.

Cost Share: Yes

Merck Sharp & Dohme Corp. USA

Description:
MK-7110 (formerly CD24Fc) is a first-in-class biologic that fortifies an innate immune checkpoint for inflammation caused by tissue injury. MK-7110 targets multiple key aspects of severe and critical COVID-19 pathogenesis including lung damage, cytokine production, blood clotting, and loss of key cells that support the immune response to SARS-CoV-2.

Unique Impact:
MK-7110 is unique in its ability to accelerate recovery while reducing disease progression in severe and critical hospitalized COVID-19 patients, with the potential to substantially reduce mortality. MK-7110 may emerge as an effective host response modulator that works either alone or in combination with other approved therapeutics.

null

Eli Lilly and Company USA

Description:
Bamlanivimab (LY-CoV555) is a monoclonal antibody with potent neutralizing activity against SARS-CoV2 and demonstrated ability to reduce the risk of hospitalization when administered to infected patients.

Unique Impact:
There are currently no approved therapeutics for treating non-hospitalized COVID-19 patients. Bamlanivimab was demonstrated to reduce hospitalization of SARS-CoV-2 infected patients by 72% in preliminary clinical studies.

null

Genentech USA, Inc. USA

Description:
ST2 is the receptor for IL-33. Inhibition of IL-33 signaling via inhibition of ST2 is predicted to reduce maladaptive hyperinflammatory responses. IL22 is a cytokine that promotes epithelial and endothelial cell repair and may prevent secondary bacterial infections.

Unique Impact:
Currently there are no ongoing clinical trials investigating these targets for the treatment of severe COVID-19 pneumonia. MSTT1041A and UTTR1147A are investigational medicines being developed for the potential treatment of hospitalized patients with severe COVID-19 pneumonia to prevent progression to ARDS and promote convalescence from ARDS.

Status: Phase 2

Cost Share: Yes

null

Merck and IAVI USA

Description:
Recombinant vesicular stomatitis virus (VSV?G)-vectored vaccine expressing the spike protein of SARS-CoV-2.

Unique Impact:
This live, virus-vectored vaccine has the potential to deliver rapid onset to immunity with a single dose. The same vector was used in Merck’s Ebola vaccine (ERVEBO®) which was licensed by the FDA in December 2019.

null

Hememics USA

Description:
HemBox™ is a Bluetooth-connected POC diagnostic device currently in development for 60-second identification of up to 17 pathogens. This test will detect the presence of SARS-CoV-2 antibodies in 1 drop of blood.

Unique Impact:
The HemBox™ POC diagnostic tool offers a real-time tool to quickly and effectively diagnose emerging diseases, like COVID-19. This Bluetooth-connected device can be used in the field in traditional care settings, resulting in a more nimble, accurate, and cost-effective testing for infectious diseases which delivers results in 60 seconds or less.

null

Hememics USA

Description:
HemBox™ is a Bluetooth-connected POC diagnostic device currently in development for 60-second identification of up to 17 pathogens. This test will detect the presence of SARS-CoV-2 antigen in nasal swabs.

Unique Impact:
The HemBox™ POC diagnostic tool offers a real-time tool to quickly and effectively diagnose emerging diseases, like COVID-19. This Bluetooth-connected device can be used in the field in traditional care settings, resulting in a more nimble, accurate, and cost-effective testing for infectious diseases which delivers results in 60 seconds or less.

null

Grifols Shared Services North America, Inc. (Grifols) USA

Description:
Both products originate from plasma donated by individuals who have recovered from COVID-19. This plasma contains antibodies that specifically target the SARS-CoV-2 virus. To produce convalescent plasma, the donated plasma will be pathogen inactivated and made available in units for infusion as an investigational therapeutic. Grifols will also purify and concentrate the virus-targeting antibodies into an investigational therapeutic called hyperimmune globulin.

Unique Impact:
 This concentrated formulation produces a more uniform product, allows for more flexibility in terms of dosing, and simplifies logistics.

Status: Phase 3

null

CIADM at Emergent Biosolutions USA

Description:
HIG is derived from plasma donated by individuals who have recovered from COVID-19. This plasma contains antibodies that target the SARS-CoV-2 virus. Using their established manufacturing process that supports VIGIV, Anthrasil and other FDA approved products, Emergent will purify and concentrate the virus-targeting antibodies into a drug product that can be administered intravenously as a potential therapeutic.

Unique Impact:
This concentrated formulation produces a more consistent product with additional safety manufacturing controls, allows for more flexibility in terms of dosing, and provides a pathway to broaden access and simplify logistics relative to convalescent plasma.

Status: Phase 3

null

SAb Biotherapeutics, Inc. USA

Description:
SAB-185 is a novel high-potency immunotherapy candidate designed to treat COVID-19. The therapy delivers human polyclonal antibodies targeted specifically to the SARS-CoV-2 virus, that are generated, collected and purified using SAB’s proprietary in vivo platform technology, without the need for human donors or serum from recovered coronavirus patients.

Unique Impact:
SAB-185 is a novel polyclonal antibody therapeutic based on a rapid response platform, being developed in partnership with DOD/JPEO based on their existing relationship to SAb.

Status: Phase 3

null

Regeneron Pharmaceuticals, Inc USA

Description:
Kevzara (sarilumab) is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor

Unique Impact:
Conducted under the existing BARDA Regeneron OTA collaboration, a U.S. Phase 2/3 clinical trial will help determine if Kevzara can be used to reduce symptoms of inflammation in hospitalized people with critical or severe COVID-19

Status: Phase 2/3

null