From the LaunchPad

Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.

SoundRocket Founder to Speak at FEDCASIC Workshop

SoundRocket Founder to Speak at FEDCASIC Workshop

by | Apr 15, 2019

If you would like to spot some serious survey nerds while enjoying the Cherry Blossoms in Washington, D.C. this year, step on down to the Bureau of Labor Statistics where SoundRocket founder Scott D. Crawford will be presenting at the The Federal Computer Assisted Survey Information Collection (FEDCASIC) Workshop. Scott will be presenting “Best Practices in Consent to Capture Geolocation Data in Self-Administered Web Surveys” in the Wednesday afternoon session on Advances in the Use of Location Data.  

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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…

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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

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…

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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

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…

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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?

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…

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