During a third phase of the pilot, set to begin in the third quarter of 2027, the EMA will open the program to IVD makers and notified bodies.

NEW YORK — Cancer Check Labs said on Thursday that it has signed an agreement to offer its blood-based cancer screening test through Evexia Diagnostics' ordering platform. The test — called ...

The assay delivers a risk score that can help clinicians to tailor treatment intensity to a patient's risk of disease progression.

The company said that Medicare administrative contractor Novitas is attempting to recoup $10.4 million based on a retrospective review of Resolve MDx claims.

Fla., the bill would require MACs to reach a decision on new LCD requests and LCD reconsideration requests within one year.

NEW YORK – Siemens Healthineers executives on Thursday expanded on previously teased plans to separate the firm's diagnostics business unit following what they called a "harsh dip" in fiscal second ...

The parties aim to incorporate iFast's rapid AST system in clinical settings and develop evidence to support broader adoption by the NHS and other UK healthcare organizations.

The company said the test can measure total testosterone, free testosterone, and sex hormone-binding globulin with an integrated workflow on a single platform.

Labcorp said the deal will streamline test ordering and reduce the time and cost of establishing and maintaining IT interfaces between the firm and its health system customers.

The firm's Lumipulse G pTau 217 Plasma measures phosphorylated tau 217 to assess whether an individual has the amyloid brain pathology characteristic of Alzheimer's disease.

The CDC and certain public health and commercial labs have serology tests for the virus while other labs including the California Department of Public Health have developed molecular tests.

Company executives said that the firm's recent purchases of Saga Diagnostics and PathAI will provide synergies throughout its oncology portfolio.