On January 31, 2020, HHS Secretary Alex Azar declared a nationwide Public Health Emergency in response to the novel coronavirus outbreak. As part of the overarching federal response, BARDA expanded existing partnerships to develop medical countermeasures to enhance health security and protect against 2019 novel coronavirus infections (COVID-19).
Diagnostics
- Cepheid is developing a rapid diagnostic test for COVID-19. The test is developed for use on Cepheid’s GeneXpert diagnostic platform which is used world-wide to test for other infections, such as tuberculosis, HIV, Group A Streptococcus (strep), and influenza. The COVID-19 test can provide results within 45 minutes, and is designed for use in clinical and hospital laboratories.
- DiaSorin Molecular LLC is advancing a molecular diagnostic test for their FDA-cleared LIAISON MDX instrument. This technology uses a sample-to-answer approach with minimal operator input and hundreds of the instruments are in use in large commercial and public health laboratories around the country.
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Hologic, Inc. is developing a molecular diagnostic test for COVID-19 that is being designed for use in conjunction with its approved Panther Fusion system. This technology can be used to process hundreds of tests in 24 hours and can provide results to clinicians in less than three hours. The Panther Fusion system provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory infections.
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Qiagen LLC is developing a test for COVID-19, QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel. The QIAstat-Dx Respiratory Panel is used to run FDA-cleared tests for 21 other respiratory pathogens. The device features easy-to-use molecular testing with novel workflows.
- Mesa Biotech is developing a rapid, point-of-care diagnostic test for 2019 novel coronavirus that is intended for clinical or lab use. The test will use the Accula Dock instrument that has 510(k) clearance and a Clinical Laboratory Improvement Amendment (CLIA)-waiver from FDA.
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Luminex Corporation is working with BARDA on the rapid development of the diagnostic test called the NxTAG CoV Extended Panel for COVID-19. The test uses RNA to detect the presence of the SARS-COV-2 virus and is intended for use with the company’s IVD MAGPIX® molecular diagnostic system. Test results are available in less than four hours. The test received FDA Emergency Use Authorization on March 27, 2020.
- Luminex Corporation is developing a COVID-19 sample-to-answer diagnostic. Luminex has designed an assay that runs on its FDA-cleared ARIES® molecular diagnostic system for presence of COVID-19 by detecting the virus in respiratory swabs. The ARIES System is Luminex’s sample-to-answer, six-color, real-time PCR instrument. ARIES assays require little training, take less than five minutes of hands-on time, and produce results in about two hours.
- Nanomix, Inc. is developing a a rapid mobile diagnostic test to detect presence of current or past COVID-19 infection in patients in as little as 15 minutes. The test detects the presence of SARS-CoV-2 antigen in nasal and throat swabs. As part of the contract, a serological test will also be developed that can detect antibodies of SARS-CoV-2 in the blood, for indication of current or past COVID-19 infection.
- OraSure Technologies Inc. is developing a rapid at-home COVID-19 diagnostic test that could bring testing closre to the patient. OraSure’s rapid, point-of-care test will be available for use both in clinical settings and at home. This test could become the first for use at home in the United States.
- Cue Health is partnering collaborate to accelerate the development, validation, and manufacturing of a portable, molecular diagnostic test capable of detecting SARS-CoV-2, the virus that causes COVID-19, in less than 25 minutes using a simple nasal swab. In this public-private partnership, BARDA will provide approximately $13.6 million and expertise for development, validation and manufacturing of the test.
- GenMark DX is developing an expanded version of GenMarks’s FDA cleared ePlex Respiratory Pathogen (RP) Panel to include assays for the simultaneous detection of SARS-CoV-2 and other respiratory pathogens. ARDA’s support follows a March 19 decision by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the GenMark’s ePlex SARS-CoV-2 test to detect SARS-CoV-2 in samples collected from people suspected of being infected with COVID-19.
Vaccines
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Sanofi Pasteur is developing a novel coronavirus vaccine candidate using its recombinant DNA platform technology that BARDA has previously supported for production of influenza vaccines. This technology produces an exact genetic match to proteins of the coronavirus and is designed for more rapid production than traditional manufacturing methods.
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Janssen Research & Development, part of Johnson & Johnson, is partnering with BARDA to help accelerate an investigational COVID-19 vaccine into clinical evaluation. Janssen will use the same approach used to develop and manufacture its investigational Ebola vaccine, which was supported by BARDA and is being used in the Democratic Republic of the Congo as part of the response to the current Ebola outbreak and to prevent spread of the disease to Rwanda.
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Moderna is partnering with BARDA to speed the development and manufacturing of SARS-CoV-2 mRNA-1273, a
vaccine to prevent COVID-19. BARDA will suppport Phase 2 and 3 clinical trials of the vaccine.
Therapeutics
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Regeneron Pharmaceuticals is developing multiple monoclonal antibodies that, individually or in combination, could be used to treat COVID-19. Under its expanded agreement with BARDA, Regeneron is leveraging its existing monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology, to develop therapeutic products to treat COVID-19 infections. VelociSuite was used to develop a promising investigational three-antibody therapeutic, which was deployed to treat Ebola in the most recent outbreak in the Democratic Republic of the Congo, as well as an investigational therapeutic to treat Middle East Respiratory Syndrome coronavirus (MERS-CoV).
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Janssen Research & Development is developing treatments for COVID-19 infections. BARDA will collaborate with Janssen to screen library of approved therapeutics as well as investigational therapeutics that have completed some clinical trials where basic safety and pharmacology data are available for these compounds. If screening is promising, candidates then could be considered for further, accelerated development, including assessment in additional clinical studies.
- SAb Biotherapeutics is developing a therapeutic, called SAB-185, which is part of a new class of immunotherapies that relies on SAb’s platform technology to produce fully human polyclonal antibodies as the basis for the drug. This technology produces the antibodies without the need for blood donations from people who have recovered from the virus; this approach produces greater quantities of the drug than the traditional human antibody donor methods.
- Grifols Shared Services North America, Inc. is developing Convalescent plasma and hyperimmune globulin products that 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.
- Emergent Biosolutions is developing a plasma-based therapeutic treatment for COVID-19 using Human Immune Globulin (HIG). 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.
- Genentech is accelerating a phase 3 clinical trial of a novel COVID-19 therapeutic treatment potential treatment of patients with severe cases of COVID-19. BARDA expanded an existing partnership with Genentech to accelerate a Phase 3 clinical trial of Actemra® (tocilizumab) as a potential treatment of patients with severe cases of COVID-19. Currently, Actemra® is approved by the U.S. Food and Drug Administration and in more than 100 countries to treat rheumatoid arthritis or other inflammatory conditions.
