Media Release

Basel, 03 April 2017

Roche launches cobas Liat PCR System with four assays into CE-markets

• First 20 minute real-time PCR nucleic acid test to detect Clostridium difficile, which supports time-sensitive diagnoses in hospitals, urgent care settings and physician offices
• Infections with Clostridium difficile can quickly become life threatening to high-risk patients
• cobas Liat PCR System also includes tests for strep A, influenza A/B and influenza A/B & RSV

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of the cobas® Liat® PCR System with four assays including first 20 minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff). Countries accepting CE mark are the first to receive access to the cobas® Cdiff test, which detects C. diff in stool specimens from symptomatic patients1 and provides rapid and definitive results in under 20 minutes. Timely and accurate diagnosis of this infection is important because it can quickly become life threatening, especially to high-risk patients such as the elderly, immuno-compromised and those undergoing antibiotic treatment.

“Roche is proud to bring the advantages of real-time PCR testing to point-of-care settings with the cobas® Liat® System,” said Roland Diggelmann, CEO of Roche Diagnostics. “The system now includes Europe’s first real-time PCR test for patients suspected of C. diff infection with results in less than 20 minutes. As one of the major causes of healthcare associated infections (HAI), C. diff not only causes significant financial burden on healthcare systems but can also lead to severe complications for the patient if the disease is not caught in time.”

The cobas® Cdiff assay, an automated, in vitro diagnostic, real time PCR test, offers minimal handling steps, a simplified workflow, and access to urgent results. Traditional diagnostic methods may take several hours for results to be delivered to clinicians. The cobas® Cdiff assay’s speed and simplicity make it ideal for STAT and out-of-hours testing, providing results when and where they are needed most.
The benefits of accurate and timely diagnoses for patient care are not unique to HAIs. The cobas® Liat® System brings real-time answers for patients and their caregivers with the assurances of PCR technology in 20 minutes or less for all assays in the portfolio. The expanded menu of assays for use on the cobas® Liat® System includes the respiratory portfolio of cobas® Strep A, cobas® Influenza A/B, cobas® Influenza A/B & RSV. The latest assay, cobas® Cdiff, is the first in the HAI portfolio and will be joined during the second quarter of 2017 by cobas® MRSA/SA for CE marked countries.

About Clostridium difficile

C. difficile is a bacterium which can cause a mild to serious infection of the lower bowels called CDI. Symptoms of CDI range from mild diarrhea to deadly colon inflammation. It is the cause of about 20% of cases of antibiotic-associated diarrhea. The spores of C. difficile are heat resistant and can therefore survive in many environments for long periods of time. Elderly people, young children, and people with weakened immune systems or chronic medical conditions are all at high risk for serious disease. In addition to its impact on individual patients, CDI accounts for a substantial drain on healthcare resources and costs.

About the cobas Liat System

Utilizing PCR technology, the innovative 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 in treatment decisions. The current portfolio of assays include cobas® Cdiff, cobas® Strep A, cobas® Influenza A/B and cobas® Influenza A/B & RSV. Assays for other infectious diseases are in development.

For more information please visit www.cobasliat.com.

The cobas® Liat® System is not commercially available in all markets.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims for improving patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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 http://www.roche.com.

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

References
¹ cobas® Cdiff package insert, Pleasanton, CA, 2017