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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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A letter criticizing actions by the US government and research institutions toward Chinese and Chinese-American scientists has garnered more than a hundred signatories.

NPR reports that researchers in New York are investigating whether it is possible to edit the genomes of human sperm.

In an opinion piece at the Nation, Sarah Lawrence College's Laura Hercher argues that everyone should be able to access prenatal genetic testing.

In Nature this week: ancient DNA uncovers presence of Mediterranean migrants at a Himalayan lake, and more.