A laboratory-initiated, online effort to reach cancer patients' relatives coupled with discounted genetic tests can increase rates of cascade testing, according to a study published in the January … [Read more...]
PRECISION MEDICINE
General Population Has Interest in Genetic Testing for Skin Cancer Risk
August 1, 2018
There is moderately high interest and follow through among the general population for genetic testing to determine melanoma skin cancer risk, according to a study published in JAMA Dermatology. … [Read more...]
TOP OF THE NEWS
Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing
April 30, 2018
Raw data from direct-to-consumer (DTC) genetic tests have an "alarmingly high" false-positive rate, according to a study published March 22 in Genetics in Medicine. Additionally, the study found that … [Read more...]
GENETIC TESTING
FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer Risk
March 27, 2018
The U.S. Food and Drug Administration (FDA) granted marketing authorization to 23andMe (Mountain View, Calif.) for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2—genetic … [Read more...]
INDUSTRY TRENDS
FDA Continues Easing DTC, Home Use Test Regulations
January 2, 2018
In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled loosened regulations in November that will effectively … [Read more...]
Two App Marketplaces Ramping Up Consumer Genomics Offerings
September 6, 2017
Two personal genome app marketplaces—Sequencing.com (San Francisco, Calif.) and Helix (San Carlos, Calif.)—are now up and running offering consumers a combined total of 55 products for purchase. While … [Read more...]
ENFORCEMENT
FDA Sends 14 Warning Letters Regarding Cancer Products
May 22, 2017
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]
DTC
Testosterone Testing Rises with DTC Ads
May 15, 2017
Televised direct-to-consumer advertising (DTCA) is associated with greater testosterone testing, according to a study published March 21 in the Journal of the American Medical Association. The … [Read more...]
FDA
23andMe Receives FDA Approval for DTC Genetic Test
April 26, 2017
23andMe and the U.S. Food and Drug Administration (FDA) recently announced that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]
FDA
23andMe Wins FDA Approval for DTC Genetic Test
April 25, 2017
23andMe and the U.S. Food and Drug Administration (FDA) announced this month that the agency has allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases … [Read more...]
