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.

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 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.

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.

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

An initial $1.35 million has been deployed to the University of California, San Francisco, to initiate the program, with additional funding announcements forthcoming.

With the license, MeMed can offer its BV test, which is intended to distinguish between bacterial and viral infections, in Canada.

NEW YORK – MicrosenseDx, a Cambridge, UK-based diagnostics developer, has inked a strategic partnership with France's ProteoGenix to speed up development of a rapid diagnostic test for sepsis.