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Quidel Gets FDA Clearance for Multiplex Strep Assay

NEW YORK (GenomeWeb) — Quidel said today that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct Strep multiplex real-time PCR assay.

The new test detects and differentiates between pyogenic Group A and pyogenic C or G streptococcal throat infections.

Group A Streptococcus are Gram-positive bacteria that reside primarily in the nose, throat, and skin and are responsible for several illnesses such as strep throat, skin infections, or toxic shock syndrome. Meantime, Group C and G Streptococcus are less understood than Group A, although some strains have been increasingly reported to cause infections similar to those caused by GAS. Most are treated with penicillin or other beta-lactams. These non-Group A strains are also found in a significant number of Group A-negative symptomatic patients, and treatment appears to shorten the symptomatic period of disease.

The new assay is part of Quidel's Lyra brand of ready-to-use PCR reagent kits specifically designed to be compatible with a laboratory's existing thermal cycler.