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November 13, 2014

FDA grants 510(k) clearance for Roche’s cobas Strep A Test

Swiss global healthcare firm Roche has been granted 510(k) clearance from US Food and Drug Administration (FDA) for cobas Strep A Test, designed to detect group A streptococcus bacterial (Strep A) DNA in throat swab specimens.

Swiss global healthcare firm Roche has been granted 510(k) clearance from US Food and Drug Administration (FDA) for cobas Strep A Test, designed to detect group A streptococcus bacterial (Strep A) DNA in throat swab specimens.

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

The test will help healthcare professionals make treatment decisions in a variety of testing locations, with a result time of 15 minutes.

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

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

Approximately 37% of sore throats among children and 5%-15% in adults are caused by Strep A, while infection is most common between the ages of five and 15.

Roche Diagnostics chief operating officer (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.

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"It also provides a significant improvement over conventional methods such as culture testing, where patients can wait up to two days to receive their result, or rapid antigen testing where confirmation with culture is needed due to significantly lower sensitivity."

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

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

The cobas Liat System was 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.

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