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CMS

Genelex is hoping that a recently published randomized-controlled trial will help it get on better footing with Medicare.

'Repeated Violations'

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.

Second Failure

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.

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.

Pages

In Science this week: genetic target for urothelial bladder cancer treatment, and more.

At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.

Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.

Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.