The tests are based on a technology that uses Fourier transform infrared spectroscopy and a proprietary technique that analyzes spectrometer test results.
The companies will work together to develop new biomarkers and diagnostic methods for Alzheimer's disease, including ones based on amyloid beta protofibrils.
The agency cleared a broad array of in vitro diagnostic tests, including assays for influenza, whooping cough, sexually transmitted infections, and opioids.
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
The companies initially expect to incorporate a CDx for Incyte's pemigatinib into Foundation Medicine's existing FDA-approved assay, FoundationOne CDx.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.
The BD business, which has annual revenues of about $100 million, offers technical services as well as peptones for cell culture media used in biopharmaceutical applications.
