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 ...

The company has developed a method to detect circulating tumor DNA in surgical drain fluid from postoperative patients to detect molecular residual disease.

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.

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

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

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.