Roche receives FDA CLIA waiver for the cobas® Influenza A/B assay


cobas Influenza A/B, the first molecular PCR test to deliver laboratory quality results in ~ 20 minutes, is now available for use in physician offices

Roche has announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas Influenza A/B test for use on the cobas Liat System. It is the first CLIA-waived test to detect Influenza A and B in throat swab specimens in ~20 minutes. Coupled with the CLIA-waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in non-traditional laboratory sites, including: physician offices, emergency rooms, health department clinics and other healthcare facilities.

“Today’s approval allows the cobas Influenza A/B 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 20-minute turnaround time of the cobas Influenza A/B test offers a much improved experience for both the patient and the healthcare professional when compared to culture testing, which can take several days for a result.”

Influenza A and B viruses are among the leading causes of respiratory infections estimated to affect 5-10% of adults and 20-30% of children every year worldwide. Coupled with the CLIA-waived cobas Strep A test, the cobas Influenza A/B test will provide greater access for patients to receive a faster diagnosis and treatment in a decentralized setting, removing the wait for confirmatory results.

About the cobas Liat System

Utilizing polymerase chain reaction (PCR) technology, 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 CLIA waived.

View the full press release here.

Visit the cobas Liat System page to learn more about the cobas Liat System.