Roche receives FDA CLIA waiver for the cobas® Liat PCR System and Strep A assay

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cobas Strep A, the first molecular PCR test to deliver laboratory quality results in ~15 minutes, now available for use in physician offices and retail clinics

Roche has announced that the U.S. Food and Drug Administration (FDA) has 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 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.”

Strep A causes about 37% of sore throats among children1 and 5-15% in adults2, and it is most common between the ages of 5 and 153. The cobas Liat PCR System will provide greater access for patients to prompt diagnosis 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 cleared. Roche has also submitted the cobas Influenza A/B test for CLIA waiver.

View the full press release here.

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

*The cobas Influenza A/B test is currently pending CLIA waiver in the United States.

 

 


1 Shaikh N, Leonard E, Martin JM (September 2010). "Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis". Pediatrics 126 (3): e557–64. doi:10.1542/peds.2009-2648.

2 Shulman, ST; Bisno, AL; Clegg, HW; Gerber, MA; Kaplan, EL; Lee, G; Martin, JM; Van Beneden, C (Sep 9, 2012). "Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America.". Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 55 (10): e86–102. doi:10.1093/cid/cis629.

3 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001663