Alere Receives 510(k) Clearance for Flu Test

June 16, 2014

Waltham, Mass.-based Alere said Monday that it has received FDA 510(k) clearance for the Alere I Influenza A and B test, the first and only molecular test to detect and distinguish those viruses in less than 15 minutes.

The test involves the extraction and analysis of DNA or RNA strands to detect sequences that are associated with viral and bacterial causes of infections, the company said. The user-friendly platform utilizes isothermal nucleic acid amplification technology that doesn’t require thermo cycling or DNA purification, Alere says. The platform is able to deliver polymerase chain reaction-caliber results more quickly and in a broad range of settings, the company adds.

Clinical performance was demonstrated in a study at eight U.S. l sites during the 2012-13 flu season. The investigators collected 585 nasal swab specimens from patients with flu-like symptoms and evaluated them using Alere I or a viral culture.

The test will be available nationwide, said spokeswoman Jackie Lustig, adding the company anticipates commercial delivery by the beginning of the respiratory season in September. The test was launched in Europe earlier this year.

The company has tests in development for Strep A, C. difficile, respiratory syncytial virus RSV and chlamydia /gonorrhea. — Kellen Owings

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