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

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

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.

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 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.

Under the collaboration, Tampa, Florida-based Detect-Ion and Mayo Clinic Florida will work to identify biomarkers of Pseudomonas aeruginosa — an antibiotic-resistant bacterium that is a key cause of ...

The senator is asking stakeholders with relevant experience and knowledge of CPT coding contracts to respond to a questionnaire.

The initiative, which was initially launched in 2020, will fund efforts to develop AI tools to improve diagnosis of Lyme disease.