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.

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

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.

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.

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

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.