Basel, 19 May 2015
Roche Receives FDA CLIA Waiver for the cobas Liat PCR System and Strep A assay
- cobas Strep A, the first molecular PCR test to deliver laboratory quality results in ~15 minutes, now available for use in physician offices and pharmacies
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the 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.
About the cobas Strep A test
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.
About the cobas Liat System
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.
*cobas Influenza A/B is not currently CLIA waived in the United States and testing sites outside the clinical laboratory.
The system is not commercially available in all markets.
About 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.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit roche.com.
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1. Shaikh N, Leonard E, Martin JM (September 2010). "Prevalence of streptococcal pharyngitis and streptococcal carriage in children: a meta-analysis". Pediatrics 126 (3): e557–64. doi:10.1542/peds.2009-2648.
2. Shulman, ST; Bisno, AL; Clegg, HW; Gerber, MA; Kaplan, EL; Lee, G; Martin, JM; Van Beneden, C (Sep 9, 2012). "Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America.". Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 55 (10): e86–102. doi:10.1093/cid/cis629.