Quidel receives FDA clearance for its Lyra molecular PCR assay

April 28, 2014

Quidel Corporation has received clearance, via the De Novo Request process, from the United States Food and Drug Administration (FDA) to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay. This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.

Strep throat, or streptococcal pharyngitis, is the most common illness from Group A Streptococcus infections. Group C and G Streptococcus (GCS and GGS, respectively) bacteria are less understood than Group A bacteria, although some strains of GCS and GGS have been increasingly reported to cause infections similar to those caused by GAS. Most are treated with penicillin or other beta-lactams.

Lyra Direct Strep Assay accurately identifies pyogenic Group A and pyogenic Group C or G. Non-group A strains, especially Group C and G, are found in a significant number of Group A negative symptomatic patients (≥ 20%), and treatment appears to shorten the symptomatic period of the disease. The Lyra Direct Strep Assay kit includes an extraction-free, three-step sample preparation process that does not require automated extraction. This direct-to-amplification procedure allows the assay to generate a result in just over an hour. Lyra molecular PCR reagent kits are designed to be compatible with a laboratory’s existing thermocycler.

“We are pleased to receive FDA clearance for our Lyra Direct Strep Assay,” says Douglas Bryant, president and chief executive officer of Quidel Corporation. “This assay allows hospital laboratories to detect possible Strep infections in patients who have Group Strep A, C, or G infections.”

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