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