The UK's Medicines and Healthcare products Regulatory Agency is the first regulatory agency globally to approve PrecivityAD2 as an in vitro diagnostic.

In a separate agreement, Quest will provide lab services for end-stage kidney disease and specialized water testing for Fresenius and its partners.

NEW YORK – What were the articles that gained the most interest from 360Dx readers last week? Here are the top five: ...

The company aims to soon launch two tests to aid the treatment of dermatomycosis and is developing other tests for healthcare ...

NEW YORK — Dutch diagnostics firm MRC Holland said this week that five of its blood-based tests for hereditary breast and ovarian cancer (HBOC) syndrome have received certification under Europe's In ...

CMS officials said they have implemented national controls and sought repayment from dozens of healthcare providers and suppliers.

The companies have been collaborating on the development of Kryptos' molecular tests, and Osang led Kryptos' $10 million financing round in 2024.

The single-use blood lancing device is intended to produce microliter capillary whole-blood samples and provide an alternative to finger-prick blood draws. It produces a blood volume of up to 600 ul ...

NEW YORK – With the launch of two point-of-care molecular assays for sexually transmitted infections, Roche Diagnostics is preparing to enter a new commercial market. The assays run on the firm's ...

In particular, the cuts could hurt the FDA's efforts to scale up its expertise and review capabilities in emerging areas like digital- and AI-based devices.