Quidel Gets FDA Clearance For Its Lyra Molecular PCR Assay

(RTTNews) - Quidel Corp. (QDEL) said Tuesday that it has received clearance, via the De Novo Request process, from the United States Food and Drug Administration to market its Lyra Direct Strep Assay, a multiplex real-time PCR assay.

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

Group A Streptococcus are Gram-positive bacteria, mainly residing in the nose, throat and skin; they are responsible for several illnesses, ranging from strep throat or skin infections to severe illnesses.

Lyra Direct Strep Assay accurately identifies pyogenic Group A and pyogenic Group C or G. Non-group A strains, especially Group C&G, are found in a significant number of Group A negative symptomatic patients 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 time-consuming automated extraction. The fast and easy direct-to-amplification procedure allows the assay to generate a result in just over an hour.