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...]
FDA
FDA Grants Approval for 23andMe DTC Genetic Test
April 10, 2017
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or … [Read more...]
GENETIC TESTING
Studies Address Impact of DTC Genetic Testing
November 21, 2016
Consumers buying direct-to-consumer personal genome tests (DTC-PGT) want to believe good news, according to an article published in the September issue of Nature Biotechnology. While participants' … [Read more...]
DTC
RealTime Laboratories Offering Direct-To-Consumer Mycotoxin Test
August 4, 2016
Texas-based RealTime Laboratories has decided to offer its mycotoxin test directly to consumers. The test is used to determine the level of exposure individuals have had to mold. Some forms of … [Read more...]
DTC
Few DTC Genetic Test Customers Share Results With Health Providers
April 4, 2016
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies While few direct-to-consumer (DTC) genetic testing consumers share their results with a health care provider, most who do are … [Read more...]
DTC
FDA Challenges DTC Genomic Tests from Startup Labs
March 24, 2016
Although the laboratory sector is at loggerheads with the U.S. Food and Drug Administration (FDA) over the regulation of LDTs, that has not prevented the agency from warning two nascent players from … [Read more...]
COMPLIANCE
Marketing of Laboratory Tests to Consumers: Is a Practitioner Order Enough to Avoid FDA Enforcement?
March 21, 2016
Danielle Sloane, Esq., Bass, Berry & Sims Courtney Ginn, Esq., Bass, Berry & Sims Laboratory developed tests (LDTs) are tests designed, manufactured, and used within a single laboratory. … [Read more...]
GENETIC TESTING
New Evidence Addresses Preferences for, Implications of Returning Sequencing Results
March 15, 2016
Clinical uses for comprehensive sequencing, including whole exome sequencing (WES) and whole genome sequencing (WGS) are increasing. Although some recommendations exist for the reporting of secondary … [Read more...]
DTC
FDA Issues Informational Queries to Two Startup Labs
March 8, 2016
Although the laboratory sector is at loggerheads with the U.S. Food and Drug Administration (FDA) over the regulation of LDTs, that has not prevented the agency from warning two nascent players from … [Read more...]
