RUO

Toward the end of 2013, the US Food and Drug Administration surprised many by taking action on a number of divisive and complex areas in the personalized medicine space.

Ambry Genetics and GE Healthcare, who each released a new 26-gene sequencing service last week, have disclosed that both of their new services are based on Illumina's TruSight Tumor panel for somatic variant detection in solid tumors on the MiSeq platform.

Members of a US House of Representatives subcommittee have called on the US Food and Drug Administration to respond to "significant concern" regarding the agency's draft guidance document on research-use-only and investigational-use-only diagnostic products.

This article has been updated to correct a typographical error.

By Turna Ray

Given that RUO/IUO products are being marketed and used by life science players in numerous ways, the FDA's proposed restrictions will not be an easy task for industry to implement or for the agency to enforce.

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A federal grand jury has indicted Elizabeth Holmes and Ramesh Balwani for alleged wire fraud in conjunction with their activities at Theranos.

Nature News reports that some developers are nervous about GitHub's acquisition by Microsoft.

A direct-to-consumer genetic testing company sent out used spit kits, CNBC reports.

In PLOS this week: comparison of commercial bisulfite kits, new method to predict essential proteins, and more