The chemiluminescence-based immunoassay is used for the direct quantitative measurement of free testosterone in serum or plasma, with results in 48 minutes.
Biomy has developed its DeepPathFinder digital pathology platform to analyze images to classify cell and tissue types in specific regions.
The expanded clearance adds the Ventana DP 600 slide scanner to Roche's previous whole-slide imaging system that was cleared last year.
Labcorp will take over the daily operations of three Inspira Health hospital labs, and it will serve as the primary lab for Inspira's physician network.
Innovaccer on Thursday announced separately that it has closed a $275 million Series F funding round that includes participation from Danaher Ventures and others.
The funding will be used to move the ARGO-HT research platform into an FDA-cleared system to support the development of diagnostic tests.
The TissueCypher assay is designed to identify patients with Barrett's esophagus who are at risk of progressing to esophageal cancer.
Physicians Toxicology Laboratory had been accused of encouraging client healthcare practices to order drug tests for all patients regardless of medical need.
Last week, readers were most interested in a story about the progress made by test developers toward commercializing rapid tests for sepsis.
The firm said that the unsecured $1.5 billion revolving credit facility through 2030 replaces another $1.5 billion credit facility through 2026.
FDA officials said that the draft guidance is meant to address recommendations from two reports on the agency's response to COVID-19.
NEW YORK – After two years of decline in 2022 and 2023, the 360Dx Top 30 rebounded in 2024, rising 4 percent year over year.