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Roche C. difficile Assay Among FDA-Cleared Tests in September

NEW YORK (360Dx) – The US Food and Drug Administration cleared Roche's Cobas Cdiff Nucleic acid test last month for the detection of the toxin B (tcdB) gene of toxigenic Clostridium difficile, the agency said on its website.

The test was among several that received 510(k) clearance from the FDA in September, including tests by Radiometer Medical and Sanguina.

Roche's test, which is for use on the company's Liat platform, is an automated qualitative in vitro diagnostic test leveraging real-time PCR to detect the tcdB gene of toxigenic C. difficile in soft or liquid stool specimens obtained from patients suspected of having C. difficile infection. The test is intended as a diagnostic aid in conjunction with clinical and epidemiological risk factors, according to a document filed with the FDA.

The Cobas Cdiff detects tcdB target-specific and IC-specific oligonucleotide sequences. tcdB is a major toxin implicated in C. difficile pathogenesis and allows for the differentiation of toxigenic C. difficile strains from non-toxigenic strains, Roche said in its FDA document. It added that primers and probe oligonucleotide sequences were designed to detect C. difficile-conserved sequences without cross-reacting with other Clostridium genus organisms, or other organisms found in normal gut flora.

The test uses silica magnetic particle-based nucleic acid extraction and TaqMan probe-based real-time PCR amplification and detection. According to Roche, no reagent preparation or additional steps are required other than adding the biological sample in media to the Cobas Cdiff assay tube.

Also in September, Radiometer Medical, part of Danaher, received FDA clearance for its AQT90 Flex analyzer, AQT90 Flex Myo Test kit, and AQT90 Flex CKMB Test kit.

The AQT90 Flex is an immunoassay instrument, which leverages quantitative determination of time-resolved fluorescence to assess the concentrations of clinically relevant biomarkers in whole-blood and plasma specimens to which an anticoagulant has been added. The platform is intended for use in point-of-care and laboratory settings.

The AQT90 Fly Myo Test kit is an IVD assay for quantitatively determining myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 Flex instrument. The assay is for aiding in the diagnosis of heart disease.

The AQT90 Flex CKMB Test kit is an IVD assay for quantitatively determining creatine kinase isoform MB in DETA or lithium heparin whole-blood or plasma specimens on the AQT90 Flex analyzer. It is intended as an aid in diagnosing myocardial infarction.

The FDA also provided 510(k) clearance for Sanguina's AnemoCheck, a semiquantitative colorimetric assay for determining total hemoglobin and calculated hematocrit in whole blood. The rapid diagnostic can be used in the POC, clinical, and doctor office laboratory setting.

Other assays that received FDA clearance last month include Cepheid's Xpert Xpress Strep A test, Hologic's Panther Fusion Flu A/B/RSV assay, and Alere's i Influenza A & B test.