Roche receives FDA clearance for strep A test on cobas Liat System

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA in throat swab specimens. The cobas Strep A test runs on the cobas Liat System, a molecular point of care diagnostic system, which will be launched later this year. With a time to result of just 15 minutes, the cobas Strep A test achieves outstanding sensitivity aiding healthcare professionals to make immediate, informed treatment decisions in a variety of testing locations.

Strep A is the cause of strep throat, as well as certain skin infections, scarlet fever, and toxic shock syndrome. About 37% of sore throats among children¹ and 5-15% in adults² are caused by Strep A and infection is most common between the ages of 5 and 15³.

“The cobas Strep A test is easy to use and provides accurate results to support a treatment decision in just 15 minutes, much faster than current technologies,” said Roland Diggelmann, COO of Roche Diagnostics. “It also 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.”

The new cobas Strep A test adds to the growing portfolio of assays designed for use with the cobas Liat System, enabling healthcare professionals to perform molecular PCR testing in a variety of settings with speed, accuracy, reliability and minimal training. The analyzer and two initial assays (cobas Influenza A/B and cobas Strep A) are both CE Marked and FDA cleared. Roche expects to begin sales of the system and assays later this year.

*The cobas Liat System is not currently CLIA Waived in the United States

References

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