Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.
When the pandemic began forcing companies to close their physical doors in March 2020, SoundRocket’s Founder and Chief Vision Officer Scott D. Crawford packed up a few belongings and told employees, “Let’s see how this goes. I’m sure we’ll return in a couple of...
More news in the consumer genomics space came this month when direct-to-consumer genetic testing company Ancestry announced they are discontinuing their AncestryHealth business. This move comes just months after receiving FDA approval for a direct-to-consumer...
Helix made headlines when they announced authorization from the U.S. Food & Drug Administration (FDA) for a whole exome sequencing platform, called the Helix Laboratory Platform. In the same breath, they also announced they obtained 510(k) clearance for their new...
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...
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…
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…
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…
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…
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…