While labs overwhelmingly welcomed the ruling, it could make it more difficult for firms that want FDA's imprimatur for LDTs to get such tests reviewed by the agency.

Last week, readers were most interested in a story about a report a possible sale of Qiagen, which sent its stock soaring.

The agreement complements Diasorin's US commercial organization and recently expanded sales force dedicated to the Liaison NES system.

Under the distribution agreement, Gradientech's QuickMIC rapid AST system will be made available to Greek hospitals.

The agency cleared lab-based and point-of-care infectious disease and clinical chemistry tests as well as software for digital pathology.

NEW YORK — Scientific instrument maker Horiba said on Wednesday that it has received CE IVDR certification for its Yumizen H500 CRP benchtop hematology analyzer. The point-of-care system performs ...

NEW YORK — The US Food and Drug Administration has issued warning letters to four direct-to-consumer health testing companies for selling unauthorized blood collection kits for HIV diagnosis.

The US Court of Appeals for the Federal Circuit remanded the case to the Patent Trial and Appeal Board to consider patent validity.

In addition to pushing cuts off until the beginning of 2027, the bill would update the data collection period used to establish the 2027 lab rates from 2019 to 2025.

The agreement will enable Beijing-based RocGene to distribute its qPCR systems, reagents, and consumables in South Korea and to explore additional market strategies.