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Roche Point-of-Care Flu/RSV Test Gets 510(k) Clearance, CLIA Waiver

NEW YORK (GenomeWeb) – Roche announced today it has received 510(k) clearance from the US Food and Drug Administration as well as CLIA waiver for a point-of-care molecular test to detect and distinguish influenza A, influenza B, and respiratory syncytial virus.

The 20-minute Cobas Influenza A/B & RSV test runs on Roche's Liat system, a rapid PCR-based platform that currently also runs waived assays for Group A Strep and flu A/B alone.

"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, Roche's head of molecular diagnostics noted in a statement. The Influenza A/B & RSV test has been validated on 40 common flu strains and seven strains of RSV, the firm said.

Roche's flu A/B test was shown last year to impact patient care, while a flu A/B, RSV test from Cepheid was cleared and waived in December.