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.

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 ...

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" ...

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.

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.

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.

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

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.