The US Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the Roche's cobas Strep A test for use on the cobas Liat System. It is the first CLIA-waived PCR test to detect Strep A in throat swab specimens in ~15 minutes.
CLIA waiver allows for broad use of the test by healthcare providers in non-traditional laboratory sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
“Today’s decision allows the cobas Strep A test to be utilized in clinical settings that previously relied on rapid antigen technology, which is less sensitive and often requires confirmatory testing,” said Roland Diggelmann, COO, Roche Diagnostics. “The ~15-minute turnaround time of the cobas Strep A test offers a much improved experience for both the patient and the health care professional when compared to culture testing, which can take several days for a result.”
Strep A causes about 37% of sore throats among children1 and 5-15% in adults2, and it is most common between the ages of 5 and 153. The cobas Liat PCR System will provide greater access for patients to prompt diagnosis in a decentralized setting, removing the wait for confirmatory results.
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.
Utilizing polymerase chain reaction (PCR) technology, the cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare professionals to perform molecular testing in a variety of settings with speed, reliability and minimal training. Definitive results are generated in 20 minutes or less to aid a treatment decision. The analyzer and two initial assays, cobas Influenza A/B and cobas Strep A, are both CE Marked and FDA cleared. Roche has also submitted the cobas Influenza A/B test for CLIA waiver.
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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics.