NEW YORK (GenomeWeb) – Roche Diagnostics said on Monday it has received CE mark for its Liat point-of-care platform and an assay for Clostridium difficile, along with three other assays which previously received CE marking. The Liat System complete test menu is now commercially available in countries accepting CE mark.
The Liat system performs real-time PCR in a tube-based format, using spatial thermal cycling to enable results in 20 minutes or less.
The POC tests, which were all previously CE-marked, include the cobas Influenza A/B, cobas Strep A and cobas Influenza A/B & RSV. These assays have also been approved by the US Food and Drug Administration and CLIA waived.
The test for C. diff is also now available in countries accepting the CE mark, bringing the total menu there to four assays. Like other Liat assays, the C. diff test is an automated, in vitro diagnostic, real-time PCR test, that requires minimal handling steps and allows for a simplified workflow. The test uses stool specimens from symptomatic patients, and will be "Europe’s first real-time PCR test for patients suspected of C. diff infection with results in less than 20 minutes," said CEO of Roche Diagnostics, Roland Diggelmann, in a statement.
The C. diff test is also the first in the firm's hospital-acquired infections portfolio for Liat. Roche anticipates an additional HAI test, to detect and distinguish staphylococcus aureus and methicillin-resistant staphylococcus aureus, to be CE marked in the second quarter of this year.