A San Diego molecular diagnostic company announced Thursday it has been awarded a contract from the U.S. Department of Health and Human Services to fund development of its coronavirus diagnostic test, which the company says would provide results in about 30 minutes.
Mesa Biotech Inc. will receive both $561,330 in funding and "technical expertise" from the HHS's Biomedical Advanced Research and Development Authority — or BARDA — to complete developmental work needed to obtain Emergency Use Authorization from the U.S. Food and Drug Administration.
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The FDA's emergency authorizations fast-track unapproved medical products for use during a public health emergency.
Mesa says its Accula SARS-CoV-2 test utilizes throat swabs to detect SARS-CoV-2, the virus that causes COVID-19.
"As the coronavirus situation escalates and the demand for testing far exceeds capacity, we are encouraged by the support of HHS in the development of our Accula SARS-CoV-2 Test," said Hong Cai, Mesa Biotech's co- founder and CEO.
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"Our test, which was developed to enable rapid responses to global pandemics, will significantly compress the sample-to-result timeframe with a laboratory-quality test at the point-of-care," Cai said. "This accelerated response will enable health care providers to rapidly screen, isolate, treat or dismiss potential carriers of the virus."
In the past week, three companies with local laboratories received emergency approval from the FDA to supply COVID-19 detection tests, including Hologic Inc. and Quidel Corp. in San Diego, and Thermo Fisher Scientific Inc. in Carlsbad.
Mesa Biotech's diagnostic test is one of four to receive funding from BARDA, according to the agency.
"Diagnostics are a critical need in the overall strategy to fight this newest global public health threat," BARDA Director Rick A. Bright said. "We need increased testing capacity in the U.S. to rapidly identify, isolate and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible."
Currently, no FDA-approved diagnostics, vaccines or treatments for COVID-19 are available.
