Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.

The goal of the proposal is to "streamline and future-proof" the IVDR, particularly to relieve the burden on small- and medium-sized enterprises.

CBO's recent score tallied temporary PAMA delay as a cost rather than a savings, potentially making future delays less likely ...

Altai Capital Management intends to nominate two candidates to its board of directors at an upcoming meeting of shareholders, OraSure said.

Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.

NEW YORK – Roche said Monday that the US Food and Drug Administration has approved the company's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe ...

NEW YORK – Jefferies initiated coverage of women's heath diagnostics firm Sera Prognostics on Monday with a Buy rating and price target of $5. In a note to investors, Jefferies analyst Tycho Peterson ...

Protavio is leading the development of the IVD-grade test kit, while Repado is developing the test's analysis software.

The man unlawfully billed Medicare for hundreds of millions of dollars as part of a cancer genetics and cardiovascular genetics testing scheme, according to the DOJ.

Should the €6.3 million effort prove successful, it could lead to the adoption of Volition's assay for routine clinical use across France.

Last week, readers were most interested in a story about a PCR test from Roche for vaginitis getting CE marking.

The initiative, which was initially launched in 2020, will fund efforts to develop AI tools to improve diagnosis of Lyme disease.