Using Arima's technology, NYU researchers were able to identify a novel rearrangement in the PDL-1 gene in a pediatric brain tumor, which led to treatment with immunotherapy.
A divided Congress and the retirement of one of the VALID Act's most prominent supporters in the Senate could make passing the bill a difficult lift.
An agency official said FDA is in the process of advancing plans to regulate laboratory-developed tests through the notice-and-comment rulemaking process.
Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.
Top 10 Articles on 360Dx in 2022
In 2022 readers were most interested in a story about what happened to Cepheid's GeneXpert Omni, a point-of-care platform once touted by the company.