If you’re looking for a last minute gift for friends or family this holiday season, you may be considering direct-to-consumer (DTC) genetic testing kits. These saliva-based at-home DNA tests (offered by companies like 23andMe and Ancestry.com) are available for quick...
The NHGRI’s 10 Bold Predictions: Visions of Genomics & Society in 2030
The NHGRI, as an institute of the NIH (National Institutes of Health), is focused on the role of genomics in human health and disease. Working with key members of the genomics community, the NHGRI recently published its strategic vision in Nature.
With hope and anticipation, the NHGRI boldly predicts that . . .
Customer Trajectory: Michael Linderman
On an early June afternoon, Michael Linderman and I sat in our respective offices, our faces connected as they often are through a Zoom video call. Mine in Michigan, his in Vermont. I was eager to chat—I had only once before known someone to attend Harvey Mudd College, one of the seven contiguous Claremont Colleges huddled together in an otherwise sleepy Los Angeles suburb. I had heard stories from the other Mudd alumni I know about pranks pulled against their Caltech rivals (Google “Caltech Cannon Heist” if you want to learn more), and I wanted to know if Michael had been involved.
Personal Genetic Tests: 12,000 Gallons of Drool
When I am asked often what I do for a living – a recent story I get to say is “We watch people spit, and then ask them about their experience.” That usually draws a raised eyebrow, and often silence as the recipient of that nugget decides how to rearrange those words into something that makes more sense. Generally, they don’t get there without help.
Genomes2People Expands Partnership with SoundRocket to Improve Personal Genome Sequencing Outcomes
After about seven years with Soundrocket, the Genomes2People Research Program has re-upped and expanded the partnership with the help of a new NIH grant for its PeopleSeq Consortium study.
Decoding FDA DTC Policy in the Genetic Testing Space: The Complete Series
Prefer to read all five posts about the recent FDA Pharmacogenetics Test Report activity at once? We have compiled the full week here into this one post…
Decoding FDA DTC Policy: Part 5 – Final Thoughts
Over the course of this week, we have covered a variety of related topics that arose from the recent FDA activity around direct-to-consumer (DTC) genetic testing. Because this is so new, much is yet unknown, so the best we can do today is speculate. However, we thought we would wrap up today with a few parting ideas to consider…
Decoding FDA DTC Policy: Part 4 – The Physician/Genetic Counselor Perspective
The National Society of Genetic Counselor’s position statement on DTC testing from 2015 states that consumers have the right to make an informed decision on DTC genetic testing. As with other DTC tests based on SNP array technology, it is important that companies offering these tests are very clear when discussing their limitations. For instance, the 23andMe Personal Genome Service…
Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots
One day following the Personal Genome Service Pharmacogenetic Reports (PGSPR) approval release, on Thursday, November 1, 2018, Jeffrey Shuren, M.D., J.D. (the Director of the FDA’s Center for Devices and Radiological Health), together with Janet Woodcock, M.D., (the Director of the FDA’s Center for Drug Evaluation and Research) published a statement to warn “consumers about genetic tests that claim to predict patient’s responses to specific medications.” This statement specifically calls out tests…