In its Q3 2022 filing with the US Securities and Exchange Commission, Lucira noted that some of the delays were the result of a lack of clinical data. The firm at one point had to amend its ...

NEW YORK – After acquiring Lucira Health in a bankruptcy auction in 2023, Pfizer has decided to shut down the business, a Pfizer spokesperson told GenomeWeb.

CAP suggested in a letter to HHS that FDA regulation of LDTs conflicts with President Trump's Jan. 31 executive order instructing agencies to reduce regulations.

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.

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

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.

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

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

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 ...

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.