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.

The PCR test detects and identifies nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory infections or sore throat.

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 – Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use. The single ...

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