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Roche Gets FDA Clearance for Strep A MDx Test

NEW YORK (GenomeWeb) – Roche announced today that it has received US Food and Drug Administration clearance for its cobas Strep A test for detecting group A streptococcus bacterial DNA in throat swab specimens.

The test runs on Roche's cobas Liat System, a molecular point-of-care diagnostic system scheduled for launch later this year. The PCR-based test can detect Strep A DNA in 15 minutes when run on the Liat system, Roche said.

Roland Diggelmann, COO of Roche Diagnostics, said in a statement that the test "provides a significant improvement over conventional methods such as culture testing, where patients can wait up to 2 days to receive their result, or rapid antigen testing where confirmation with culture is needed due to significantly lower sensitivity."

Roche gained the Liat (laboratory-in-a-tube) system through its acquisition earlier this year of IQuum. In addition to the system, IQuum had already gained FDA clearance for the Liat Influenza A/B assay, a rapid, near-patient test to detect and differentiate influenza A and B.