Mesa Biotech, San Diego, has been awarded a $561,000 contract from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) for development of the company’s rapid molecular diagnostic test for the detection of SARS-CoV-2 in ’near-patient’ settings. The Accula SARS-CoV-2 test will be developed for use on the company’s commercially available platform for the Accula Flu A/Flu B and RSV tests, both of which are 510(k)-cleared and CLIA waived.
“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,” says Hong Cai, cofounder and chief executive officer of Mesa Biotech. “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. This accelerated response will enable healthcare providers to rapidly screen, isolate, treat, or dismiss potential carriers of the virus.”
The Accula SARS-CoV-2 test will be a qualitative, visually read test utilizing polymerase chain reaction technology to detect SARS-CoV-2 via throat swab samples. Similar to Mesa Biotech’s existing tests, the Accula SARS-CoV-2 test is designed for use at the point of care (for example, in temporary screening facilities, physician office labs, urgent care clinics, cruise ships, long-term skilled nursing facilities), complementing the central laboratories where current testing is performed. Mesa Biotech’s molecular POC coronavirus test, subject to regulatory approval, will enable laboratory-quality results in approximately 30 minutes.
For more information, visit Mesa Biotech.
