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Mesa Biotech Respiratory Tract Infection Test Gets FDA Clearance, CLIA Waiver

NEW YORK (GenomeWeb) – Mesa Biotech today said that the US Food and Drug Administration has cleared and CLIA-waived the company's Accula RSV respiratory syncytial virus test for diagnostic use in both children and adults.

According to the San Diego-based firm, the nasal swab test combines the superior sensitivity, specificity, and information content of laboratory-based PCR tests and the simplicity, convenience, and procedural familiarity of traditional point-of-care rapid immunoassays.

The test is the second molecular POC diagnostic on Mesa Biotech's Accula platform to receive FDA clearance and CLIA waiver after the firm's Flu A/Flu B test received similar designations earlier this year.

"The addition of [the] Accula RSV test to our Flu A/Flu B test significantly enhances our upper respiratory rapid molecular diagnostic offerings," Mesa Biotech Cofounder and CEO Hong Cai said in a statement. "It is important to have a distinct in-office diagnosis for RSV and flu, especially in young children and the elderly, to provide timely, accurate information to clinicians to ensure appropriate treatment and improved patient management." 

Mesa Biotech and Sekisui Diagnostics reached a deal in December 2017 to distribute Mesa's POC molecular system for the flu A/B test. Sekisui will also exclusively distribute the flu and RSV tests in the US and Canada under the Silaris brand.

This summer, Mesa Biotech said it snagged $23 million in new financing, which it will use to expand its manufacturing capacity and to further develop new assays.