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FDA Clears Quidel Rapid MDx Strep Test

NEW YORK (GenomeWeb) – Quidel announced after the close of the market Tuesday that it received 510(k) clearance from the US Food and Drug Administration to market the Solana Strep Complete Assay for rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus).

If throat swab specimens from symptomatic patients are identified as negative by the Solana rapid molecular assay, the specimens do not require additional testing by culture. According to Quidel, this is an industry first for Streptococcus dysgalactiae, which is a species of pyogenic beta-hemolytic Streptococcus C/G isolated from humans.

The assay also requires no upfront extraction of DNA, generates an accurate result in around 25 minutes, and can process up to 12 patient samples in that time, according to Quidel. It accurately differentiates pyogenic Group A from Group C or G, the firm said, adding that Group C and G strains are found in a significant number of symptomatic patients that are Group A-negative.

Group A Streptococcus are Gram-positive bacteria — primarily in the skin, nose, and throat — that cause conditions such as strep throat and skin infections as well as severe illnesses, including necrotizing fasciitis and streptococcal toxic shock syndrome. Strep throat, or streptococcal pharyngitis, is the most common illness from Group A streptococcus infections.

The FDA clearance comes in time for the upcoming respiratory disease season.

"With the Solana system, we've given moderately complex labs what they want: a platform that provides definitive test results quickly, and in a scalable connected format with a low total cost of ownership," Douglas Bryant, president and CEO of Quidel, said in a statement.

The Solana molecular platform employs a helicase-dependent amplification technology, which is part of the firm's AmpliVue molecular product line.

The clearance marks Quidel's fourth molecular diagnostic test to receive 510(k) clearance from the FDA for the Solana platform. The Solana Influenza A and B test received 510(k) clearance in September, the Solana Trichomonas assay was cleared in August, and the Solana Group A Strep assay was cleared in June 2015.