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.
It was a rough year for biotech stocks — the Nasdaq Biotech Index fell 22 percent even as the Dow gained 13 percent and the Nasdaq gained 8 percent.
After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.
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.
The move follows the inclusion of Cologuard in the US Preventive Services Task Force's updated colorectal cancer screening recommendations.
In Science this week: deletion of one microRNA allows pluripotent stem cells to form embryonic and non-embryonic lineages, and more.
Arizona is planning to sue Theranos for "deceptive acts" and misrepresentations of its "capabilities and operation."
If confirmed as Department of Health and Human Services Secretary, Tom Price says he will divest himself of certain holdings, according to Stat News.
Oliver Smithies, who won the Nobel Prize in 2007, has died, the New York Times reports.