Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of the cobas® MRSA/SA nucleic acid test for use on the cobas Liat System for the qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) at the point of care. MRSA and SA are both major sources of healthcare and community-associated infections. In fact, up to 53 million people carry MRSA, one of the most commonly identified antibiotic-resistant pathogens. Surveillance to manage potential MRSA/SA outbreaks has become a requirement in most healthcare facilities.
The cobas MRSA/SA test is designed to support rapid screening and surveillance of MRSA & SA – known causes of healthcare-acquired infections (HAIs), for use in emergency rooms, intensive care units, and STAT lab settings. In contrast to the multiple-day turnaround needed for culture results, Cobas MRSA/SA detects MRSA & SA in under 30 minutes enabling testing to occur prior to admission or surgery to reduce the risk of transmission within the hospital. A highly sensitive and specific assay with expanded strain inclusivity, Cobas MRSA/SA is the fastest CE-IVD cleared test in its class, delivering definitive results when and where they are needed most.
“The suffering and financial burden HAIs cause patients and healthcare systems demand effective surveillance
for infection control and prevention,” said Roland Diggelmann, CEO Roche Diagnostics. “The speed, performance, and simplicity of the cobas MRSA/SA test provide healthcare professionals with a better chance to reduce disease proliferation as well as the opportunity to make timely patient management decisions.” Cobas MRSA/SA is the fifth assay for use on the Cobas Liat PCR System and joins cobas® Cardiff as part of the HAI portfolio. Additional assays, as part of the respiratory menu, include cobas® Strep A, cobas® Influenza A/B, and cobas® Influenza A/B & RSV.
About methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)
Staphylococcus aureus (SA), a gram-positive bacteria and the genetically resistant form, methicillin-resistant Staphylococcus aureus (MRSA), have become the major causes of healthcare- and community-associated infections and have been responsible for bacterial.
outbreaks in healthcare settings worldwide. In Europe, MRSA infections are estimated to affect over 150,000 patients per year, resulting in more than 1 million excess days of hospitalization and 380 million euros in extra in-hospital costs. Surgical site infections, ventilator-assisted pneumonia, and bloodstream infections attributed to MRSA/SA colonized central lines are the most frequent manifestations of the disease. Active surveillance to identify carriers is helping to mitigate the potential consequences of the disease, providing relief to patients and healthcare institutions facing the challenges of escalating 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 30 minutes or less to aid a treatment decision. The current portfolio of assays includes Cobas MRSA/SA, Cobas Cdiff, Cobas Strep A, Cobas Influenza A/B, and Cobas Influenza A/B & RSV. Assays for other infectious diseases are in development.