Robinson Bradshaw

Topic: Genetic Future

Looking Ahead After the FDA’s DTC Meeting

Day one of the FDA’s two-day public meeting on the future of clinical DTC genetic testing is in the books. Those unable to attend in person were, unfortunately, forced to resort to Twitter coverage of the proceedings as the government declined to provide a live webcast. (I’m told there will not be a recorded webcast […]

Clearing a Path for DTC Oversight

In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, […]

Getting Our Act Together for the Second Decade of Human Genomics

[Editor’s Note: This post originally appeared at Daniel MacArthur’s blog Genetic Future, which is part of Wired Science Blogs.] We have recently summarized efforts by two state legislatures to design regulatory schemes addressing issues raised by the proliferation of genetic information about individuals. New York’s effort addresses questions of insurance coverage for genetic testing. Massachusetts’ […]

Welcome to Genomes Unzipped

I’m pleased to announce the beta launch of a new community resource for personal genomics, Genomes Unzipped. I’ve been working with a group of colleagues on this project for quite a while now. Some of the group members will be familiar to regular readers of the Genomics Law Report, including Daniel MacArthur from Genetic Future, […]

Consumer Genetics Needs More Transparency, Not Excessive Regulation

Editor’s Note: Daniel MacArthur, a researcher at the Wellcome Trust Sanger Institute in Cambridge, UK, and the author of Genetic Future, co-wrote this post, which originally appeared in Xconomy. Are you ready for consumer genetics? Is your government? Recent announcements of federal investigations into the budding direct-to-consumer (DTC) genetic testing industry suggest that authorities are […]

What Five FDA Letters Mean for the Future of DTC Genetic Testing

The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the […]

Why 23andMe’s Sample Swap is Actually an Argument In Favor of DTC Genetic Testing

Direct-to-consumer (DTC) genetic testing company 23andMe made news this week thanks to a lab mix-up that left up to 96 customers reviewing genetic data that was not their own. Full details of the mix-up, and analysis of 23andMe’s response, are available from Daniel MacArthur at Genetic Future and Turna Ray at Pharmacogenomics Reporter. 23andMe’s sample swap follows […]

Choosing to use genetic testing is an option. Ignorance isn’t.

Last week I posted a response to a column in the Sunday Times by Camilla Long, “Long’s Op-Ed on Personal Genomics Comes Up Short.” Readers of that piece may be interested in a further response (“Choosing to use genetic testing is an option. Ignorance isn’t“), which I wrote with Daniel MacArthur of Genetic Future, published today […]

Personal Genomics: A Participatory Activity

Last week the GLR covered deCODEme’s announcement that it was offering existing customers of its main competitor, 23andMe, the opportunity to have their genomic data interpreted by deCODEme’s own service. For free. Although somewhat surprising from a short-term commercial perspective, I generally liked the move by deCODE as a means to improve the company’s genomic […]

Is deCODEme Taking a Page from the 23andMe Playbook?

Daniel MacArthur of Genetic Future provides coverage of the decision by direct-to-consumer (DTC) genomics service provider deCODEme to offer existing 23andMe customers the ability to upload their raw 23andMe data to the deCODEme service. For free. MacArthur correctly notes that the value of the genome scans provided by companies such as 23andMe and deCODEme lies […]