Decoding FDA DTC Policy: Part 5 - Final Thoughts

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…

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

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 Pharmacogenetic Reports (PGSPR) panel is limited to those SNPs that are detectable by their array and is by no means an exhaustive list of all possible PGSPR variants within the genes investigated on this panel. It should also be noted…

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

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…

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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?

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…

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

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

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)…

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Republish from UNDARK: Where Scientific Mistakes Are Welcome

Republish from UNDARK: Where Scientific Mistakes Are Welcome

This is a first for the Launch Pad blog - a complete republish (with permission) of an article from another source.  The article included below hit on something that I feel strongly about - enough so that just a summary would not do it justice.  

Science is learning and growth in knowledge.  If we got it all "right" the first time, it would be a downright boring process (and not science!).  Science is about making mistakes, learning from them, and gradually (or sometimes not so gradually) improving on a shared general knowledge.

So why is it difficult for a scientist to admit to a mistake publicly?  Maybe we don't give them proper tools to "come clean".  This article introduces us to a group who wants to change that.

Check it out - it's still a messy process... 

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The Science of Direct-to-Consumer Genetic Testing – SoundRocket Partners With Academics and Industry to Understand How Genetic Information is Used

The Science of Direct-to-Consumer Genetic Testing – SoundRocket Partners With Academics and Industry to Understand How Genetic Information is Used

And if you could take a genetic test to determine if you have the gene mutations that could show you have an increased risk of having Alzheimers Disease, would you? As the U.S. FDA has started regulating and approving these tests, SoundRocket asks: are there any potential harms and limitations?

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ICYMI: Five Ways to Use Previously Collected Survey Data to Improve Quality in a Survey

An oldie but a goody!

Care should always be taken to only use previous data when it is methodologically important to do so. Here are the 5 times that reusing data to enhance your survey is actually ok.

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