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Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test

NEW YORK ─ Mesa Biotech said on Wednesday it has received US Food and Drug Administration 510(k) clearance and a CLIA waiver for its Accula Strep A molecular test.

The firm said that its visually-read Strep A cassette, which fits in the palm of a hand, has been cleared for the detection of Group A Streptococcus bacterial nucleic acid to diagnose children and adults.

Accula Strep A uses RT-PCR to detect Strep A using throat, nasal, or nasopharyngeal swab samples and provides results in 30 minutes at the point of care, Mesa Biotech added.

"Our Accula testing platform enables healthcare providers to reach a rapid diagnosis and administer the appropriate treatment, thus reducing the amount of time the patient is sick, preventing long-term health problems, and helping prevent the spread of infection," Hong Cai, cofounder and chief technology officer of Mesa Biotech, said in a statement.

Accula Strep A is the third molecular POC diagnostic test on the Mesa Biotech Accula platform to receive FDA clearance and a CLIA waiver, after tests for Flu A/Flu B and RSV.

San Diego-based Mesa received Emergency Use Authorization for its SARS-CoV-2 cassette earlier this year.

In November, the company announced a $13 million award from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for the development of a rapid point-of-care test for SARS-CoV-2 and influenza.