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...]

FDA

FDA Grants Approval for 23andMe DTC Genetic Test

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

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

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

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

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?

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

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

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...]


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