INDUSTRY TRENDS

Laboratory Initiation of Cascade Genetic Testing Spurs Uptake

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

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

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

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

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

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

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

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

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

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...]


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