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Quidel's Solana Whooping Cough MDx Clears FDA

NEW YORK (GenomeWeb) – A molecular diagnostic assay from Quidel to detect bacterial strains that cause whooping cough has received 510(k) clearance from the US Food and Drug Administration, the firm announced today.

The Solana Bordetella Complete Assay detects and differentiates Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs. The test runs on Quidel's Solana system which uses helicase-dependent amplification and processes up to 12 samples per batched run.

Whooping cough cases are thought to be on the rise because of waning vaccine-induced immunity in adults and declining vaccination of children. Pertussis and parapertussis are not easily distinguished based on symptoms. Parapertussis does tend to cause less severe illness, but it is usually not lab confirmed so its epidemiology is not well understood.

"Although whooping cough cases can be sporadic, outbreaks are often highly contagious, and we believe that this test can provide healthcare workers with the ability to quickly diagnose whooping cough and B. parapertussis," Douglas Bryant, president and CEO of Quidel said in a statement. He added that paring the test with Quidel's Virena data management system will allow clinicians to be able to see real-time positive cases at the local level, "giving them further insights into disease prevalence," and he further noted that the test rounds out the Solana molecular test offering in the respiratory category.

The Solana instrument now offers a comprehensive set of cleared assays, the firm said, allowing labs to quickly process multiple patient samples to diagnose many common diseases. Cleared Solana assays include Influenza A+B, Strep Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas, Group B Strep, and C. difficile.

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