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Roche’s test for flu A/B and RSV waived

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Aug. 16, 2016Roche announced that the Food and Drug Administration has granted 510(k) clearance and a CLIA waiver for the Cobas Influenza A/B and RSV test for use on the Cobas Liat system.

“For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame after symptoms strike,” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. “This can be challenging with current turnaround times for lab-based test results. The Cobas Influenza A/B and RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients.”

The Cobas Influenza A/B and RSV test is the third assay on the Cobas Liat system to receive CLIA waiver, following the Cobas Strep A and Cobas Influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The Cobas Liat Analyser and all three assays are FDA-cleared and CLIA-waived.

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