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The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
The university health system said that it reduced incorrectly prescribed antiviral prescriptions by almost 11 percent at the sites where it installed the Roche Cobas Liat PCR test platform.
The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).
In response to public comment on draft recommendations published last year, the USPSTF changed course and retained cotesting as an option.
Companies said at AACC that as labs grow larger, they see growth in demand for integrated, modular systems that help customers manage complexity and costs.
Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.
Since introducing new clinical platforms last year, Sciex has launched an automated sample prep system while Thermo Fisher has begun customer beta testing.
Roche Diagnostics CEO said that it seeks to continue generating cash from its current IVD businesses, in part to fund investments in digital diagnostics.
A high-sensitivity cardiac troponin T assay ruled out myocardial infarction in about 55 percent of patients within an hour, according to a new study.