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IVDMIA

During a webinar hosted this week by Genetic Alliance, Paul Radensky, a partner in the law firm McDermott Will & Emery, discussed FDA's regulation of diagnostic tests and noted that ACLA met with FDA Commissioner Margaret Hamburg to discuss a proposal for an inter-agency approach to regulating LDTs.

The IVDMIA is the first FDA-cleared test for ovarian cancer detection in the pre- and post-surgical setting and will be available for physician use in the fourth quarter.

OIVD Director Alberto Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.

Although no specific regulatory efforts were discussed during an online meeting held this week, it was apparent from the comments of agency officials that the issue of direct-to-consumer genetic testing is on the radar of both CMS and FDA.

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The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.