Roche’s 15-Minute Strep A Test Gets FDA Green Light

The FDA has cleared Roche’s cobas Strep A test for use in detecting group A streptococcal DNA in throat swab specimens. The test, which uses polymerase chain reaction technology, is the first test to provide results in just 15 minutes for the common infection, the Swiss drugmaker said.

The cobas Strep A assay will run on the cobas Liat System, a molecular point-of-care diagnostic system to be launched by the end of the year. Roche characterized the Liat platform as a compact, fast and easy-to-use system for on-demand testing in any lab.

Roland Diggelmann, chief operating office of Roche Diagnostics, said the cobas test offers a major improvement over culture testing in diagnosing group A strep, which can take up to two days for results, and rapid antigen testing, where significantly lower sensitivity requires confirmation with culture.

Strep A causes 37 percent of sore throats in children and from up to 15 percent of sore throats in adults. It can also trigger skin infections, scarlet fever and toxic shock syndrome. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.