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have called on the US Food and Drug Administration to respond to "significant concern" regarding the agency's draft guidance document on research-use-only and investigational-use-only diagnostic products.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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The United Nations is to consider a ban on field testing gene drives at a meeting being held next week, Technology Review reports.

The Associated Press reports that gene-edited food may soon be for sale.

The US Department of Health and Human Services is beginning a series of meetings on human fetal tissue research, Stat News reports.

In Cell this week: epigenetic change linked to glioblastomas, rare and low-frequency variants contributing to multiple sclerosis risk, and more.