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.
The Cobas HPV Test is now approved for use as a primary screening test with BD's SurePath and Hologic's ThinPrep PreservCyt Solution.
Revenues for Roche Diagnostics totaled CHF 6.26 billion for H1, driven primarily by demand for immunodiagnostic solutions.