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In some instances, Ventana said, a retrospective review and retesting of clinical cases using the affected dispensers would be necessary.
The test uses the same blood draw of a routine health exam and was designed to be unaffected biotin, a vitamin supplement that may skew some lab test results.
Qiagen's partnership and merger agreement with NeuMoDx may help it compete with high-volume molecular testing vendors such as Abbott, Hologic, and Roche.
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.