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

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.

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.

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

NEW YORK — Becton Dickinson said on Monday that its partner Certest Biotec has received In Vitro Diagnostic Medical Device Regulation certifications in Europe for two infectious disease assays.

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.

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

NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...

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

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 ...

Under the collaboration, Tampa, Florida-based Detect-Ion and Mayo Clinic Florida will work to identify biomarkers of Pseudomonas aeruginosa — an antibiotic-resistant bacterium that is a key cause of ...