Quidel Receives FDA Clearance for Streptococcus Assay

Quidel Corporation announce that it has received clearance, via theDe 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. 

Group A Streptococcus are Gram-positive bacteria, primarily residing in the nose, throat and skin; they are responsible for several illnesses, ranging from strep throat or skin infections to severe illnesses (necrotizing faciitis, or streptococcal toxic shock syndrome).1 Strep throat, or streptococcal pharyngitis, is the most common illness from Group A Streptococcus infections. These bacteria are spread through contact with airborne droplets from an infected person's cough, sneeze or via contaminated items such as eating utensils.2 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.3 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&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.4

Quidel's Direct Strep Assay is part of the exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler. The Lyra reagent kits provide attractive features that include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.

The Lyra Direct Strep Assay kit includes an extraction-free, three-step sample preparation process that does not require time-consuming automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in just over an hour.

"We are pleased to receive FDA clearance for our Lyra Direct Strep Assay," said 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."

Quidel also offers FDA-cleared, molecular diagnostic assays under the Lyra brand for the accurate detection of other infectious diseases, such as those caused by Influenza A and B, Respiratory Syncytial Virus, Human Metapneumovirus, and C. difficile.