NEW YORK (GenomeWeb) – Mesa Biotech announced today it has received 510(k) clearance and CLIA waiver from the US Food and Drug Administration for a test to detect and distinguish influenza A and B from nasal swab specimens.
The Accula Flu A/Flu B test cassette is the firm's first test to receive FDA clearance, and runs on the firm's Accula Testing System. Originally a spinout of Los Alamos National Laboratory, Mesa has been developing the test system for a number of years and obtained CE mark for the system and flu test last month.
Nucleic acid amplification-based molecular tests tend to perform better than immunoassays for flu testing but can be time consuming, and antiviral medications need to be taken within 48 hours of symptom onset to impact the course of infection. The Accula Flu A/Flu B test "brings PCR testing to the POC," and provides a qualitative result in approximately 30 minutes, Mesa said in a statement.
The system offers the simplicity, convenience, and procedural familiarity of traditional POC rapid immunoassays — using a portable, palm-sized dock and a disposable, assay-specific test cassette — while providing the sensitivity, specificity and information content of laboratory-based PCR testing, according to the company.
The clearance and waiver "is an outstanding validation" of the testing platform, said Hong Cai, cofounder and CEO of Mesa Biotech. "We remain focused on additional product development and commercialization of our expandable PCR system," he added.
The relatively higher cost of CLIA-waived flu tests compared to immunoassays has been considered a barrier to uptake by some. Mesa Biotech has previously described an instrument costing in the hundreds of dollars, with a projected menu including a flu/RSV, Group A Strep, and norovirus.
Mesa Biotech has an agreement with Sekisui Diagnostics for exclusive product distribution rights in the US and Canada. The Accula Flu A/Flu B test will be marketed by Sekisui Diagnostics under the Silaris brand.