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Roche’s cobas Strep A Test obtains FDA 510(k) approval

Switzerland-based Roche has received 510(k) approval from the US Food and Drug Administration (FDA) for its cobas Strep A Test to detect group A streptococcus bacterial (Strep A) DNA in throat swab specimens.


The cobas Strep A test has been developed for use with a molecular point of care diagnostic system, cobas Liat System, which will be launched later this year, said Roche.

The Strep A test will help healthcare professionals in taking treatment decisions in a variety of testing locations, with a time to result of around 15 minutes.

Roche Diagnostics COO Roland Diggelmann said: "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.

"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 cobas Strep A test can detect Strep A DNA obtained from throat swab specimens in 15 minutes with the cobas Liat System, utilizing polymerase chain reaction (PCR) technology.

Roche said that the cobas Strep A test also received CE mark approval.

The cobas Liat System has been designed for on-demand testing in physician clinics, pharmacy, and hospital lab settings. It includes cobas Liat Analyzer and assays such as cobas Influenza A/B and cobas Strep A.

Strep A is the cause of strep throat and certain skin infections, scarlet fever, and toxic shock syndrome.

Image: The administration and R&D buildings, Roche Diagnostics Ltd, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.