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26th May 2015  Content supplied by: Roche Diagnostics

CLIA Waiver for Roche's cobas Liat PCR System and Strep A assay

Roche has been granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Strep A test for use on the cobas® Liat System. It is the first CLIA-waived PCR test to detect Strep A in throat swab specimens in ~15 minutes. CLIA waiver allows for broad use of the test by healthcare providers in non-traditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.

“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,” said Roland Diggelmann, COO, Roche Diagnostics. “The ~15-minute turnaround time of the cobas Strep A test offers a much improved experience for both the patient and the health care professional when compared to culture testing, which can take several days for a result.”

Using PCR technology, the cobas Strep A test which is CE Marked and FDA cleared, can detect Strep A DNA obtained from throat swab specimens in ~15 minutes with the cobas Liat System. The cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. The analyzer and two initial assays, cobas Influenza A/B* and cobas Strep A, are both CE Marked and FDA cleared. Roche has also submitted the cobas Influenza A/B test for CLIA waiver.



Date Published: 26th May 2015

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