NEW YORK – The US Food and Drug Administration granted 20 in vitro diagnostics-related 510(k) clearances in April for devices and assays, including antimicrobial susceptibility, infectious diseases, ...

NEW YORK – US Congressman Neal Dunn, R-Fla. introduced a bill into the House of Representatives on Tuesday that would update the Clinical Laboratory Improvement Amendments (CLIA) to provide new ...

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

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

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.

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.

NEW YORK – Roche Diagnostics is preparing to launch a new blood-based test for Alzheimer's disease in Europe after announcing this week that it has received CE marking. The Elecsys pTau217 test, a ...

As part of the deal, certain EHE members will be able to book a phlebotomist from Getlabs to go to their home or office to collect a patient sample for testing at Labcorp.

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.

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 ...