Roche announced that the US 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.

Utilizing polymerase chain reaction (PCR) technology, the cobas Strep A test can detect Strep A DNA obtained from throat swab specimens in 15 minutes with the cobas Liat System. The cobas Strep A test is CE Marked and FDA cleared.

The Roche cobas Liat is a compact, fast and easy to use molecular diagnostic system designed for on-demand testing in physician clinics, pharmacy, and hospital lab settings. The system includes the cobas Liat Analyzer and growing portfolio of assays, including cobas Influenza A/B and cobas Strep A.

Streptococcus pyogenes (Strep A) is a ubiquitous pathogen that causes a wide range of human infections, including pharyngitis, sinusitis, lymphadenitis, pyoderma, endocarditis, meningitis, septicemia, tonsillitis, impetigo, and upper respiratory tract infections. Strep A is capable of initiating two nonsuppurative complications – acute rheumatic fever and post-streptococcal acute glomerulonephritis – which can have severe negative consequences on the health and well-being of infected patients. Accurate diagnosis of acute infection is necessary to properly treat the disease using appropriate antibiotic therapy. If left untreated, Strep A infections can lead to other serious, sometimes life-threatening conditions, including rheumatic fever, scarlet fever, peritonsillar abscess, necrotizing fasciitis, and streptococcal toxic shock syndrome.