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.

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.

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 ...

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

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.

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.

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.