FDA Warns Exact Sciences that CRC Assay Requires Premarket Approval
 
Exact Sciences said this week that it has received a warning letter from the US Food and Drug Administration notifying the company that its colorectal cancer screening assay will require premarket approval.
 
In the letter, the FDA's Office of In Vitro Diagnostics Device Evaluation and Safety said it believes the company’s DNA-based PreGen-Plus assay is a medical device and therefore requires premarket approval or clearance.

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The US Food and Drug Administration has approved Kite Pharmaceuticals' CAR T-cell therapy for large B-cell lymphomas, the New York Times reports.

Kaiser Health News reports that gene therapies could cost more than a million dollars.

Worcester Polytechnic Institute researchers have received a grant to combine biology and computer science for high school students.

In Nature this week: variants associated with obsessive-compulsive disorder, review of key CRISPR enzymes, and more.