There was a lot of growth in the precision medicine field in the past year, and some experts believe the FDA's decision to hold off on regulating LDTs could spur more innovation.
CMS revoked the Medicare billing privileges of Alere's diabetes unit, Arriva Medical, claiming it had submitted claims for deceased patients.
After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.
Mertz outlined the lab industry group's policy positions after FDA's decision to delay final guidance on regulation of lab tests and upcoming implementation of a payment law.
The certification ensures that the biobank has the authority to handle and test human samples for the Cancer MoonShot 2020 initiative.
Tests sold by Veracyte, CareDx, Biodesix, Genomic Health, BioTheranostics, and fetal aneuploidy trisomy risk testing will see improved rates from earlier proposals.
CMS final pricing for a number of CPT codes brings positive news for various gene sequencing procedures and multi-analyte algorithm assays.
The bill comes amid questions about the efficacy of Epigenomics' Epi proColon, the only blood-based cancer screening test approved in the US.
In a final policy on comprehensive genomic profiling, Palmetto said that approved registries will have to commit to sharing data, among other requirements.
The committee questioned stakeholders about the impact of FDA oversight of LDTs, and whether there was any consensus about how to move forward on a divisive topic.