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

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...]

23andMe’s Return Signals Expected Growth in DTC Market

In what is being hailed as "a milestone for consumer genetics," personal genomics company 23andMe (Mountain View, Calif.) received U.S. Food and Drug Administration (FDA) approval to launch … [Read more...]

23andMe’s Approval Marks ‘Baby Step’ in DTC

While personal genetics company 23andMe (Mountain View, Calif.) was granted authority by the U.S. Food and Drug Administration (FDA) in late February to market the first direct-to-consumer (DTC) … [Read more...]

DTC Genetic Testing Market Further Consolidates for the Sake of Data

In a surprising move, biotech giant Amgen (Thousand Oaks, Calif.) announced the acquisition of deCODE Genetics (Reykjavik, Iceland) on Dec. 10, further consolidating the direct-to-consumer (DTC) … [Read more...]

Comprehensive Guidance Updated for Genetic Testing in Kids

Updating policies written over the past two decades, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) have issued a comprehensive joint … [Read more...]

No Negative Long-Term Personal Effects Seen With DTC Genetic Testing

More than a third of individuals completing direct-to-consumer (DTC) genetic tests share their results with their own physician within a year, and this sharing is associated with higher screening test … [Read more...]

Regulation of Personal Genomics Again Questioned With FDA’s Warning Letter to 23andMe

The warning letter the U.S. Food and Drug Administration (FDA) sent to 23and-Me (Mountain View, Calif.) has reignited a fierce debate pitting the merits of FDA regulation of personal genomics tests … [Read more...]

23andMe Complies With FDA Directive; Company Halts DTC Health-Related Genomic Analysis

Thirteen days after receipt of a warning letter from the U.S. Food and Drug Administration (FDA), 23andMe (Mountain View, Calif.) announced it will stop offering its health-related genetic tests while … [Read more...]

DTC Testing May Pose Actual Clinical Risk

Misinterpretation of direct-to-consumer (DTC) genetic testing results could pose a clinical risk to individuals, according to a case study published in Clinical Pharmacology & Therapeutics. In the … [Read more...]


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