Genetic Testing

Customer Trajectory: Michael Linderman

Customer Trajectory: Michael Linderman

by | Aug 20, 2019

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.

read more
Personal Genetic Tests: 12,000 Gallons of Drool

Personal Genetic Tests: 12,000 Gallons of Drool

by | Aug 20, 2019

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.

read more
Decoding FDA DTC Policy: Part 5 – Final Thoughts

Decoding FDA DTC Policy: Part 5 – Final Thoughts

by | Nov 16, 2018

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…

read more
Decoding FDA DTC Policy: Part 4 – The Physician/Genetic Counselor Perspective

Decoding FDA DTC Policy: Part 4 – The Physician/Genetic Counselor Perspective

by | Nov 15, 2018

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…

read more
Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

by | Nov 14, 2018

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…

read more
Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

by | Nov 13, 2018

What Are User Comprehension Studies and Why are they Required by the FDA?

Unlike tests that are overseen by health care professionals where a conversation may take place about the meaning of results, direct-to-consumer tests bypass the traditional patient-doctor relationship and deliver results directly to patients (or consumers).  A well-known example of a direct-to-consumer test is a pregnancy test that one may purchase at any pharmacy or similar retail store…

read more
Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

by | Nov 12, 2018

While many of us were heading out to dish out candy (or tricks) to local goblins and superheroes this past Halloween, the FDA rounded out their suite of De Novo reclassification orders on DTC genetic testing.  The latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health Risk (GHR) tests (including a specific case of Genetic Health Risk Report for BRCA1/BRCA2)…

read more