Close Menu

regulatory approval

BioCompute Objects provide a structured language and format for sharing computational protocols and procedures for next-generation sequencing data with regulatory agencies.

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.

Pages

A new study catalogues the genome and evolutionary history of the oak family, UPI reports.

Dog DNA testing is a growing market, but there's still a lot of uncertainty about the accuracy of the results, the Boston Globe says.

A University of South Florida researcher is testing bone fragments to determine if they belong to Amelia Earhart.

In Cell this week: antisense Piwi-interacting RNA responses to endogenous retroviruses, proteomic patterns in hepatocellular carcinoma, and more.