The oversubscribed round will support final assay development and manufacturing readiness for an early access program launch.

The study included 3,014 patients evaluated based on high-risk screening, symptomatic presentation, or identification of a mass on imaging.

While the effort could bring new requirements to the reimbursement process, it could also make payments more standardized and ...

While the effort could bring new requirements to the reimbursement process, it could also make payments more standardized and predictable.

The FDA clearances address laboratory challenges including staff shortages, limited space, and rising test volumes, the firm said.

Last week, readers were most interested in a story about Roche's molecular respiratory panel receiving CE marking.

Exclusive US distributor Phase Scientific will now roll out the rapid test via an established commercial footprint and other distribution agreements.

The money will be used to procure and administer 20/20 BioLabs' OneTest blood-based MCED assay to more than 1,400 firefighters. The funding comes from Maryland's Professional and Volunteer Firefighter ...

The firm also announced its Q4 and full-year 2025 financial results, reporting that revenues for the year doubled compared to 2024.

Clinical labs are exploring new business opportunities as consumers take more control of their healthcare and bypass their ...

The approval marks the eighth FDA-approved CDx indication for the company's PD-L1 IHC 22C3 pharmDx, Code SK006, test for use with Keytruda.

The firm validated its test for one new indication in 64 patients with a variety of solid tumors, including breast, ovarian, melanoma, and head and neck cancers.