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Roche Receives FDA Clearance for Strep A Test

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Roche has 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.