The company noted that if PAMA cuts go into effect at the beginning of next year as scheduled, they would negatively impact its 2026 revenues by around $100 million.

The California-based firm said that its VeriClear EbV MARV Rapid Antigen Test will be used for the detection and differentiation of Ebola and Marburg virus infections.

The US Food and Drug Administration granted 510(k) marketing clearances for various tests to aid the diagnosis and treatment of infectious diseases, among other products.

As the shutdown drags out, there could be delays in regulatory processes and payments for medical services as well as the ...

Researchers hope to soon commercialize a simple, inexpensive, and accessible screening test that uses taste as a detection ...

Regulatory burdens have raised the capital requirements for early-stage companies, causing many to do what would have been ...

A report that private equity firms and a group of banks were preparing bids for the firm drove up the price of Hologic's stock by as much as 4 percent on Thursday.

NEW YORK – Following a flurry of recent partnership and investment announcements, Hemex Health is transitioning from startup to scale-up phase. The developer of rapid point-of-care testing recently ...

The University of Washington spinout's test is used to detect and analyze protein biomarkers in a low-cost test, with results in 15 minutes.