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regulatory approval

The test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.

The New York State Clinical Laboratory Evaluation Program has approved the company's FoundationACT blood-based circulating tumor DNA assay.

UgenTec and R-Biopharm's collaboration will cover the software's development, regulatory approval, and launch.

The belief among genomics experts that one day drugs would be given based on genomic abnormalities that cut across tumor types became reality this week.

The New York State Department of Health had previously provided conditional approval of the microRNA classifier for diagnosing indeterminate thyroid cancer cases.

Researchers saw a small, but significant uptick in self-reported healthy eating and exercise frequency after 23andMe or Pathway Genomics DTC testing.

The re-emergence of direct-to-consumer genetic health risk tests has healthcare providers worried once again about their impact and utility.

Following the premarket authorization of 23andMe's tests, the agency may allow other firms to sell similar tests DTC without having to submit them for review.

Bit Quicker, Actually

An analysis in the New England Journal of Medicine finds that the US Food and Drug Administration reviews new drugs faster than the European Medicines Agency.

A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.

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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.