Diagnostics is already operating somewhat separately from the firm's other two business units under its new organizational structure, company officials said.

Chairman and CEO Adam Schechter said that deals may open up as hospital systems grow concerned about Medicaid cuts and the end of Affordable Care Act subsidies.

Sedia's single-use, qualitative immunoassay, called the Asanté HIV-1/2 Oral Fluid Test, detects antibodies to HIV-1 and HIV-2 using oral fluids in as little as 20 minutes and is intended for use by ...

The bill was one of several discussed during a Thursday hearing by the Health Subcommittee of the House of Representatives' ...

President and CEO Jim Davis said he believes PAMA reform will pass this year but said another temporary delay will likely be needed to postpone cuts slated for February 1.

Last week, readers were most interested in a story about concerns about BillionToOne's Unity NIPT due to false negative results.

The physical and digital biobank supports the integration of artificial intelligence in acute care diagnostics development.

NEW YORK — Point-of-care testing firm Truvian Health said on Monday that nine tests that run on its TruVerus benchtop blood analyzer have received 510(k) clearances from the US Food and Drug ...

For full-year 2025, MDxHealth's preliminary revenues are $109 million, up 21 percent from 90.0 million in 2024. It billed 49,180 tissue-based units, up from 18 percent year over year, and 71,920 ...

The company said its preliminary revenues for the fourth quarter were at least $21 million, and its full-year 2025 revenues are expected to grow to $77 million.

Coupling biomarker-guided screening with a targeted treatment bundle reduced newborn mortality, hospital stays, and other complications over standard care, according to a recent study.

The deal makes Guardant's blood-based colorectal cancer screening test available to active duty US military members.