In 2023 the institute was also deemed an EU reference lab for high-risk IVDs for the detection of hepatitis viruses, retroviruses, and respiratory viruses.

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

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

CBO's recent score tallied temporary PAMA delay as a cost rather than a savings, potentially making future delays less likely ...

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.

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

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

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.

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