14 February 2018 - - US-based molecular diagnostic company Mesa Biotech Inc. has received 510(k) clearance and clinical laboratory improvements amendments (CLIA) waiver from the US Food and Drug Administration for its Accula Flu A/Flu B test, the company said.
The company's Flu A/Flu B test cassette will be its first available test in the US market.
The FDA, CDC, and WHO all acknowledge that existing post of care (POC) immunodiagnostic tests perform poorly. Rather, molecular testing is recommended, as influenza is a rapidly evolving virus.
Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnosis is required to direct therapy for these viral infections.
The CLIA-waived Accula Flu A/Flu B test brings PCR testing to the POC providing a qualitative result in approximately 30 minutes to guide same day treatment decisions. The system offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based polymerase chain reaction (PCR) testing.
The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.
Privately held Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests. The company has developed an affordable PCR testing platform designed specifically for point-of-care infectious disease diagnosis.