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FDA Clears Roche Cobas C. Diff Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance to a Clostridium difficile test from Roche, the firm announced today.

The test detects the C. diff toxin B gene from stool samples. It runs on Roche's cobas 4800 system, which combines automated sample preparation with real-time PCR amplification and detection for mixed batch testing.

"The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow when compared to other molecular methods," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care."

The test adds to the US infectious disease menu on the cobas 4800, which also includes assays for Chlamydia trachomatis/Neisseria gonorrhoeae and human papilloma virus. A test for Staphylococcus aureus and methicillin-sensitive S. aureus was FDA cleared this year.

The cobas 4800 platform also runs an assay for the BRAF V600 mutation, which is cleared as a companion diagnostic for the melanoma drugZelboraf (vemurafenib), and an EGFR test that is acompanion diagnostic for Tarceva (erlotinib). A KRAS mutation assay on the 4800 was cleared earlier this month.