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CMS gave labs an additional year to gear up for the implementation of the Protecting Access to Medicare Act of 2014 and clarified key programmatic definitions.

Since CMS has yet to issue a final rule, legislators are worried that the agency will "improperly rush" implementation to meet the Jan.1, 2017 deadline.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

Legal heavyweights representing the lab industry group explain their arguments for why FDA lacks authority to regulate lab tests.

In an intellectual exercise, Conley plays devil's advocate to the American Clinical Laboratory Association's legal arguments for why FDA doesn't have authority over lab tests.

At the second day of an LDT workshop, industry players told FDA to provide more guidance and details on regulatory areas that the initial draft guidance doesn't touch on.

Although lab industry players have talked of suing the FDA, it hasn't amounted to much more than just talk until this week, when ACLA announced it had retained two prominent lawyers to advise the group on LDT regulatory matters. President Alan Mertz discussed ACLA's legal options in an interview.


The New York City Police Department will be removing DNA profiles from a local database if they are from people who were never convicted of a crime, the New York Times reports.

Science reports that accusations of sexual assault against a microbiome researcher has also led to questions about his academic certifications.

Wired reports that researchers are analyzing the DNA fish leave behind in water to study their populations.

In Science this week: comprehensive cellular map of the human thymus, evidence of admixture between the ancestors of Neanderthals and Denisovan and a 'superarchaic' population.