Roche launches PCR molecular diagnostic system for point of care environment

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The cobas® Liat System is the only FDA cleared molecular diagnostic platform to offer real- time PCR results in 20 minutes or less

News provided by

Roche

Dec 16, 2014, 01:00 ET

PLEASANTON, Calif., Dec. 16, 2014 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas^® Liat System—a fast, compact , easy to use, molecular diagnostic platform, designed for on-demand testing in physician clinics, pharmacies and hospital lab settings. The system includes the cobas^® Liat Analyzer and a growing portfolio of assays, including the cobas^® Influenza A/B and cobas^® Strep A nucleic acid tests.

Utilizing Nobel prize winning 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 cobas^® Liat System, enables us to extend the reach of PCR technology," said Paul Brown, Head of Roche Molecular Diagnostics. "This system offers significant benefits in testing time and accuracy, over current methods used to diagnose infectious disease within the physician office or urgent care clinic. It eliminates the need for time-consuming confirmatory testing and can provide critical answers to both the healthcare professional and patient during a consultation."

The portfolio is available in the U.S. and within Europe. The analyzer and two initial assays, cobas^® Influenza A/B and cobas^® Strep A, are both CE Marked and FDA cleared.

*The cobas^® Liat System is not currently CLIA waived in the United States and testing sites outside the clinical laboratory are not available in all markets.

About the cobas^® Liat assays

The cobas^® Strep A and cobas^® Influenza A and B tests offer outstanding sensitivity, aiding healthcare professionals to make immediate, informed treatment decisions in a variety of testing locations. Utilizing polymerase chain reaction (PCR) technology, the cobas^® Influenza A/B test can be used in the differential diagnosis of Influenza A virus and Influenza B virus RNA, or in the detection of Strep A DNA with cobas^® Strep A, in 20 minutes or less. Additionally, the cobas^® Influenza A and B test covers over 30 commonly found strains of Influenza A and B. More information is available at www.cobasliat.com or go.roche.com/cobasliat.

About Influenza A and B (Flu)

Influenza is an acute respiratory illness caused by infection with the Influenza virus. Influenza viruses consist of three types: Influenza A, Influenza B and Influenza C. In the U.S., Influenza A/H1N1, A/H3N2 and Influenza B are the predominant seasonal viruses. Influenza A and B viruses are among the leading causes of respiratory infections, estimated to affect 5-10% of adults and 20-30% of children every year worldwide. Influenza is primarily spread by breathing in infected droplets formed when a person with the flu sneezes, coughs, or talks. Symptoms include fever, cough, headache, fatigue, muscle pain, sore throat, and runny nose. Older people, young children, and people with weakened immune systems or chronic medical conditions can be at high risk for serious disease. Each year, approximately 3 to 5 million people develop severe illness and 250,000 to 500,000 people die from the flu.[1]

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.

About Roche

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 Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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 www.roche.com.

All trademarks used or mentioned in this release are protected by law.

For media inquiries please contact:
Bob Purcell, Roche Molecular Diagnostics
888-545-2443

Claudia Panozzo, Austria
+43 1 277 87 360

Silvia Zucca, Italy
+39 039 2817 612

Francisco Aguilar-Alvarez, Spain
+34 93583 4011

Eudes de Villiers, France
+33 4 76 76 31 26

Banu Kutlu, Turkey
00902123060606

Harald Borrmann, Switzerland
+41 41 799 6253

Kate Hoile, UK
+44 1444 256591

Jan Schreiber, Germany
+49 621 759 5156

Mike Weist, US
+1 317 521 3112

[1] World Health Organization. Influenza (Seasonal) Fact Sheet No 211. http://www.who.int/mediacentre/factsheets/fs211/en/. Accessed 25 Sep 2014.