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FDA Grants CLIA Waiver for Roche Strep A Assay

NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has granted CLIA waiver to Roche's cobas Strep A assay on the cobas Liat system.

Roche acquired the Liat, or lab-in-a-tube, technology a year ago when it bought diagnostics developer Iquum for $275 million upfront and up to $175 million in milestones. The acquisition included an FDA-cleared influenza A/B assay on Liat. Roche has since stated its intention to populate the system with other tests, and officially launched Liat late last year.

The PCR-based group A Streptococcus assay runs in about 15 minutes on the fully automated platform, and is CE marked and FDA cleared.

"Today’s decision allows the cobas Strep A test to be utilized in clinical settings that previously relied on rapid antigen technology, which is less sensitive and often requires confirmatory testing," Roland Diggelmann, COO of Roche Diagnostics, said in a statement, adding that the turnaround time is also an improvement over culture testing.

With CLIA waiver, the test can now be run in low-complexity healthcare settings such as physician's offices and pharmacy clinics.

It is the second point-of-care molecular test ever to be granted CLIA waiver, and the first for Strep A. Alere's point-of-care system runs a CLIA-waived flu assay, and last month the FDA approved a Strep A assay for the platform, which Alere has also submitted for CLIA waiver. Roche, meanwhile, said today that it has submitted its FDA-approved influenza A/B test for CLIA waiver.

Nearly 40 percent of pediatric sore throat cases and up to 15 percent of adult cases are caused by strep infections. Other companies offering nucleic acid amplification tests for strep include Focus Diagnostics, Meridian Bioscience, and Quidel, while firms like Hibergene and Tetracore have assays in development.