FDA Clears Roche's Strep A Infection Test

Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its cobas Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA.

The cobas Strep A uses polymerase chain reaction (PCR) technology to detect Strep A DNA obtained from throat swab specimens. The assay runs on the cobas Liat System, Roche’s molecular point of care diagnostic system that will be launched later in 2014. The cobas Strep A test yields results in 15 minutes.

Streptococcus pyogenes (Strep A) is a ubiquitous pathogen and the culprit behind strep throat, certain skin infections, scarlet fever, and toxic shock syndrome. An estimated 37 percent of sore throats among children and 5 to 15 percent in adults are caused by Strep A. As the pathogen is capable of inducing two nonsuppurative complications, namely acute rheumatic fever and post-streptococcal acute glomerulonephritis, accurate diagnosis is a must in order to administer proper antibiotic therapy.

Roland Diggelmann, COO of Roche Diagnostics, 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.”

Earlier this year, Roche also announced the FDA approval of another test based on its cobas Liat system following the unanimous recommendation of the FDA’s Medical Devices Advisory Committee. The company received approval for its cobas HPV (Human Papillomavirus) Test as a first-line primary screening test for cervical cancer in women 25 years old and above.