The company also said that its FoundationOne test has been accepted for parallel review as part of the Expedited Access Pathway program with the FDA and CMS.
Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.
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.