FDA Grants 510(k) Clearance & CLIA Waiver for Point-of-Care Flu Test

The US Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver for Mesa Biotech Inc.’s point-of-care (POC) Accula Flu A/Flu B test; this will be the company’s first available test in the US market.

Mesa Biotech’s single-use Flu A/Flu B Test Cassette, “hermetically seals after sample addition and prior to nucleic acid amplification to ensure test accuracy.” According to the company, each cassette includes nasal swabs, a nasal swab buffer, and disposable pipettes, which are all needed to run the test. The cassettes contain stabilized dried reagents, which “eliminate the need for refrigerated storage and transportation.”

This announcement comes as much of the United States is experiencing widespread flu activity in what the Centers for Disease Control and Prevention (CDC) reports is the country’s its most severe flu season since the 2009 influenza A (H1N1) pandemic.

“By definition, POCT are not performed in a central laboratory setting. Therefore, the ideal POCT must be simple to perform by individuals providing patient care, and have low probability of yielding incorrect results,” Kenneth Smith writes in a recent American Society for Microbiology blog.

At the time of posting—October 23, 2017—there were only 8 CLIA-waived influenza POCT. Mesa Biotech’s is the newest addition.

Diagnosing influenza can pose a challenge for physicians, as many of the initial symptoms are comparable to individuals suffering from upper respiratory virus infections. According to Mesa Biotech, the existing point-of-care immunodiagnostic tests “perform poorly, despite their ease-of-use,” thus, “molecular testing is recommended instead.” The need for rapid diagnostics is evident, as antiviral medications are only effective when taken within 48 hours of symptom onset, according the company.

“The Flu A/Flu B product is the first test cassette on our PCR testing platform to receive FDA clearance. This announcement follows our CE Mark certification and launch of our Flu A/Flu B test last month in Europe,” Mesa Biotech’s co-founder and CEO Dr. Hong commented in the press release. “This is an outstanding validation of our testing platform and we remain focused on additional product development and commercialization of our expandable PCR system.”