Representatives from industry, academia, the FDA, and insurance companies gathered for a joint FDA- and American Association for Cancer Research-sponsored workshop.
The Swiss firm also reported an 8 percent year-over-year increase in diagnostics sales in the second quarter at constant exchange rates.
The test is now the first FDA-cleared test for use with the SurePath collection medium and vial for processing cervical cancer screening samples.
The recent approvals underscore the usefulness of procalcitonin as a sepsis biomarker, even as newer molecular approaches to diagnosing the condition hit the market.
The agency has approved the cobas EGFR Mutation Test v2 as a companion diagnostic for Genentech's non-small cell lung cancer drug Tarceva (erlotinib).
The firm received CLIA waiver of a strep A assay on its Liat platform yesterday, and a favorable evaluation of its influenza A/B assay was published last week.
The group hopes its proposed regulatory framework might strike a compromise between different industry stakeholders.
NEW YORK (GenomeWeb) — Researchers at Johns Hopkins University have performed the first validation of the Cepheid Xpert Flu assay in a population of emergency room patients with acute undifferentiated respiratory illness.
Roche's test becomes the second PCR-based MRSA test approved for clinical use in the US, joining Cepheid's Xpert MRSA/SA nasal assay for the GeneXpert PCR platform.