During the year the industry saw continued consolidation, the end of a key advisory body, the rise in DTC testing and advanced diagnostics, and another stab at PAMA reform.

This story has been updated from a previous version to clarify the timeline for growth of the Spotfire installed base. NEW YORK – Nearly three years since BioMérieux launched its smaller, faster take ...

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

NEW YORK – The European Commission on Tuesday proposed a new regulation that would amend the In Vitro Diagnostic Regulation (IVDR) with the goal of "simplifying and reducing the burden of the rules" ...

NEW YORK – An investor holding stake in OraSure Technologies, Altai Capital Management, announced Wednesday that it intends to nominate two candidates to OraSure's board of directors, hinting at a ...

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.

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.