A prospective study with 15,000 subjects for lung cancer, initiated in 2023, is underway to support the IVD product ...

The Tissue Regeneration & Mechano-Biology Lab, headed by Prof. Wuertz-Kozak ... Our work on role of miR-155-5p in IVD degeneration with a focus on inflammation and mechanosensing was published in Cell ...

PrognomiQ has raised $34 million in a series D round led by Seer, boosting its total funding to over $135 million. The funds ...

“Laboratory developed testing services are not ... of the development and use of some LDTs and in-vitro diagnostics (IVDs) offered as LDTs, the FDA’s proposal to apply its device regulations ...

The FDA's final rule of LDTs includes a four-year phaseout to bring IVDs under its regulation, but there are obstacles.

Early diagnosis through the use of in vitro diagnostics (IVDs) plays a critical role in patient outcomes and in supporting the healthcare system as a whole. IVDs are defined in the new EU IVDR ...

Once the lab uses up the initial GraftAssure marketing samples ... Obtain regulatory clearance for clinical use: Oncocyte is pursuing IVD clearance from the FDA for VitaGraft+, which is based on the ...

He is the founder of China Association of Clinical Laboratory Practice Expo (CACLP), China’s largest professional exhibition in IVD industry.

PrognomiQ will use this round of funding to advance development of an early detection test for lung cancer, which the company ...

"It is specifically designed for use by trained clinical laboratory personnel proficient in PCR techniques and IVD procedures ...

PrognomiQ was recently granted a Clinical Laboratory Improvement Amendment license to support ... in lung cancer that was ...