BARDA and Chembio Diagnostics, Inc. of Hauppauge, New York, are collaborating on the development of two COVID-19-related tests that leverage Chembio’s proprietary Dual Path Platform (DPP®) and provide results in under 20 minutes.
The first is the DPP SARS-CoV-2 Antigen test system that rapidly detects SARS-CoV-2 antigen in nasal swabs. This test received initial funding from BARDA in July 2020. Chembio submitted an EUA package on Oct 15, 2020, for the SARS-CoV-2 antigen test. The new collaboration leverages the existing partnership to request 510(k) clearance of this test, as well as to develop and request an EUA on an expanded respiratory panel diagnostic.
The second is the DPP Respiratory Panel antigen test system which simultaneously detects and differentiates between influenza A, influenza B and SARS-CoV-2 using a single nasal or nasopharyngeal sample. BARDA funding should enable the company to seek Emergency Use Authorization (EUA) of the test for use during the 2020-2021 influenza season. If authorized or approved, both tests could be used at point-of-care, enabling timely patient management and support containment of COVID-19.
During current and future influenza seasons, public health professionals and healthcare providers need rapid, point-of-care testing to determine if individuals with symptoms of respiratory illness have flu or COVID-19. Rapid testing enables these professionals to quickly determine the cause of the illness in order to make appropriate and timely treatment decisions, as well as contain continued spread of COVID-19.
Both tests utilize Chembio’s Micro Reader 1 (MR-1) and Micro Reader 2 (MR-2) analyzers. The FDA previously cleared the MR-1 for use with Chembio’s multiplex test for Human Immunodefiency Virus (HIV) and Syphilis, and its test for Zika virus.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
About Chembio Diagnostics, Inc.:
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Chembio (Nasdaq:CEMI) is a leading point-of-care diagnostics company focused on detecting and diagnosing infectious diseases, including COVID-19, sexually transmitted disease, and fever and tropical disease. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.