The test has met coverage requirements for use with patients with non-small cell lung cancer with resectable or unresectable disease in the surveillance setting.

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

The Amsterdam-based company recently received IVDR certification for other tests including one for phenylketonuria.

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

The PCR-based point-of-care assays, which return results within 20 minutes, have received regulatory approval from the US Food and Drug Administration earlier this year.

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

NEW YORK – Staff cuts at the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) could hamper the agency's ability to review medical device submissions, including for ...

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 ...