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.
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.
The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).
The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.
In a speech to Congress, President Donald Trump called the drug approval process at FDA "slow and burdensome."
The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.
According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.
An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.
US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.
In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.