Roche has 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, chief executive officer 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.
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.
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.