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FDA Clears Quidel's Amplivue Group A Strep Test

NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.

Group A Streptococci reside primarily in the nose, throat, and skin and are responsible for several illnesses, of which streptococcal pharyngitis, or Strep throat, is the most common.

Clearance of the Group A Strep assay follows 510(k) clearance of Quidel's AmpliVue Group B Strep Assay last year and its C. difficile assay in 2012. The company also offers an FDA-cleared assay for HSV1 and HSV2 on the AmpliVue platform.

Like these other AmpliVue assays, the GAS test combines isothermal helicase dependent amplification with the company's lateral flow technology in a hand-held format. According to Quidel, the assay has "superb clinical accuracy" and does not require culture confirmation of negative results, expensive thermocycling equipment, or other upfront testing costs.

"We are very pleased with the rapid pace of our AmpliVue assay development." Douglas Bryant, Quidel's president and CEO, said in a statement. "Our sales force now has a broader suite of fast and accurate molecular assays that offer a compelling value, especially among smaller labs that generally do not test using molecular methods."