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.

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

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.