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FDA Clears Quidel's Solana MDx Platform, Group A Strep Assay

NEW YORK (GenomeWeb) – Quidel said today that the US Food and Drug Administration cleared the firm's Solana molecular platform and associated Group A Streptococcus assay. 

Solana leverages the helicase-dependent amplification technology that also underpins Quidel's AmpliVue molecular technology. Solana can process up to 12 patient samples in a 30-minute run, saving time for healthcare professionals in moderately complex settings, Quidel said. 

The Group A Strep Assay is a rapid qualitative test for detecting ß-hemolytic, Group A Streptococcus nucleic acids isolated from throat swab specimens from patients with symptoms of pharyngitis. It requires no culture confirmation of negative results and no upfront extraction of DNA, Quidel said. 

The Solana instrument and the Group A Strep assay received CE marking during the first quarter.

"We believe that Solana is uniquely positioned in the marketplace because it offers customers the ability to batch the more commonly run assays, provides superb clinical accuracy, and can also serve as an elegant batch method for confirmation of rapid immunoassay result when needed," Quidel President and CEO Douglas Bryant said in a statement.