NEW YORK – Mesa Biotech said on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Accula SARS-CoV-2 test.
The PCR test is designed for the qualitative visual detection of nucleic acid from the SARS-CoV-2 virus in combined throat swab and nasal swab specimens from patients suspected by their healthcare provider of having COVID-19.
The 30-minute assay, read visually, uses the company's Accula system, which is designed for point-of-care use, for example in screening facilities, physician office labs, urgent care centers, or long-term nursing facilities. "Our test will provide a highly accessible means for healthcare professionals to access laboratory-quality results close in their office to aid in the decision to isolate, treat, or dismiss potential carriers of the virus," said Mesa Biotech Cofounder and CEO Hong Cai in a statement.
Mesa Biotech has been working on clinically validating its COVID-19 test for a while. Last week, the San Diego-based company received $561,330 from the Biomedical Advanced Research and Development Authority for the development and commercialization of the test.
The company already sells commercial tests for influenza and RSV that run on its system.