Bacterial Infection Assay Receives First Simultaneous FDA Clearance and CLIA Waiver

A Group A Streptococcus (GAS) diagnostic test from Quidel Corporation (San Diego, CA, USA) has received the first-ever simultaneous FDA clearance and CLIA waiver via the new, time- and cost-saving Dual Submission Program of the United States Food and Drug Administration (FDA).

Quidel has received 510(k) marketing clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its “Sofia Strep A+ FIA” fluorescent immunoassay (FIA)-based test for rapid detection of infections by GAS bacteria. Sofia is Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure-alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within 5 minutes of patient specimen application.

The FDA’s Dual Submission Program substantially reduces time, effort, and cost as the process previously required two independent, sequential submissions of the 510(k) and CLIA waiver applications. Successful simultaneous passage thus allows the diagnostic industry to pursue its commercial goals sooner and to more quickly bring new products to the marketplace where they can help healthcare professionals better serve their patients. It is anticipated that now Sofia Strep A+ FIA will further expand placement of new Sofia instruments, a process that has accelerated throughout 2014. The CLIA waiver allows Quidel to sell the assay to all CLIA categories of laboratories in the USA, including the CLIA-waived segment comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments.

"We are pleased and very proud to receive the first joint clearance and CLIA waiver designation under the FDA's new Dual Submission Program. We can now provide our CLIA-waived customers with a highly accurate, quick and easy-to-use solution for the diagnosis of Strep A infections in our best-in-class Sofia format," said Douglas Bryant, president and CEO of Quidel, "Our customers love the Sofia platform, and because Strep A is our highest-volume product, we believe that our Sofia Strep A+ FIA has the potential to increase Sofia system installations and utilization well into 2015."

The Sofia Analyzer was 510(k) cleared in 2011, and then Quidel's first Sofia FIA, the Sofia Influenza A+B FIA, received CLIA waiver in 2012. In addition to the Sofia Influenza and Sofia Strep A FIAs, Quidel also provides the CLIA-waived Sofia Respiratory Syncytial Virus (RSV) FIA and the Sofia hCG FIA.

Quidel now provides a broad spectrum of FDA-cleared Strep A diagnostic assays, including: 2 assays on the Sofia platform (one CLIA-waived), 3 different assays on the QuickVue platform (two CLIA-waived), and 2 new molecular assays – AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G).

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Quidel Corporation