In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
Siemens Healthineers received clearances for an assay used to detect and monitor acute pancreatitis, and for tests and controls used to detect Zika.
At the Henry Ford Health System in Southeast Michigan, bringing on the Roche Cobas Liat for flu testing led to a season of headaches before it started paying off.
In US influenza testing, providers see growth in placements within hospital emergency departments, physicians' offices, urgent care centers, and retail clinics.
At constant exchange rates, diagnostics revenues were up 2 percent, primarily due to the immunodiagnostics business.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
The program started in 2014, originally to increase access to HIV diagnostics, and provides special pricing to qualifying organizations in eligible countries.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
With two FDA-cleared platforms available, the technology is drawing clinicians interested in reaping its near-term benefits while preparing for its future impact.