Last week, readers were most interested in a story about the reasons behind the rapid adoption of BioMérieux's SpotFire syndromic qPCR instrument.

Approaches incorporating rapid or digital PCR, CRISPR, syndromic testing, and multimodal systems reached new milestones this year.

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.

NEW YORK – As 2024 closed, the US Food and Drug Administration had — much to the chagrin of clinical labs — at last made good on its decades-long promise to regulate laboratory-developed tests (LDTs), ...

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

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

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.

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.

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.