ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.
Centers for Medicare & Medicaid Services pick Seema Verma has been confirmed, the Wall Street Journal reports.
Genelex is hoping that a recently published randomized-controlled trial will help it get on better footing with Medicare.
A federal inspection report obtained by the Wall Street Journal describes deficiencies at Theranos' Arizona lab.
At the Personalized Medicine World Conference, stakeholders and the former FDA commissioner discussed how regulation can advance personalized medicine amid political uncertainty.
Prior to being closed, Theranos' Arizona lab failed an inspection by regulators, according to the Wall Street Journal.
The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs.
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.
An opinion piece in the New York Times urges lawmakers to keep genetic protections in place.
Research funding in Canada is to remain mostly the same, ScienceInsider reports.
In Science this week: random DNA replication errors play role in cancer, and more.
The Bill and Melinda Gates Foundation embarks on an open-access publishing path.