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Roche POC MDx Flu Test Gets CLIA Waiver

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted CLIA waiver to a point-of-care molecular influenza assay from Roche, the company announced today.

Run on the firm's Cobas Liat platform, the fully-automated test detects and differentiates influenza A and B in about 20 minutes using real-time PCR, Roche said.

“Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results," Roland Diggelmann, COO of Roche Diagnostics, said in a statement. With its quick turnaround time, the Cobas Influenza A/B test, which provides lab-quality PCR results, enables "healthcare providers in all settings to give prompt and confident diagnosis and treatment to patients,” he added.

The flu assay targets highly conserved regions of the flu A and B genomes to cover over 30 strains, and is the second FDA-approved, CLIA-waived test on the Cobas Liat. The test is also CE-marked. Roche's Strep A assay for Liat was CLIA-waived in May.

The Liat platform performs real-time PCR in a tube-based format, using spatial thermal cycling to enable rapid results, as previously reported. Roche recently provided GenomeWeb an update on its Liat menu development pipeline, which includes a combination flu A/B plus respiratory syncytial virus test, an assay targeting both Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), and a test for Clostridium difficile.