Robinson Bradshaw

Topic: DTC genomics

2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked: 1. Will the $1,000 genome live up to the hype? 2. Will personal genomics stay DTC? 3. How will the ongoing gene patent debate affect the progress of personalized medicine? 4. […]

Personal Genomics Goes to Washington

Next week, the eyes of the personal genomics world will be focused on Washington, D.C., where the FDA and Congress will be meeting separately to consider the industry’s future. First, the FDA will convene a highly-anticipated public meeting (July 19th and 20th) to “discuss how the agency will oversee laboratory-developed tests (LDTs).” The FDA announced last month a proposal […]

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 […]

Breaking: Congressional Committee Requests Additional Information Regarding 23andMe Sample Swap

Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Today the Committee has followed up with another letter, this one directed to 23andMe president […]

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 […]

Breaking: Congress to Investigate DTC Genetic Testing

The United States House of Representatives Committee on Energy and Commerce today launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to three prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Here is the announcement from the Committee: Today Chairman Henry A. Waxman, Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak, and Subcommittee Ranking […]

DNA Spit Kits Off Walgreens’ Shelves? Try Amazon.com

Earlier today I examined the FDA’s emerging regulatory “policy” with respect to direct-to-consumer (DTC) genetic tests. The thrust of the FDA’s comments to date appear to focus on Pathway’s proposed partnership with Walgreens, specifically the fact that Pathway’s tests would be available in a “drugstore,” as the impetus for the FDA’s prompt and public regulatory […]

More on Pathway and Walgreens: The Price of Visibility and Adding the FTC to the Regulatory Mix

Yesterday, direct-to-consumer (DTC) genetic test provider Pathway Genomics and drugstore giant Walgreens announced a partnership that will place Pathway’s tests on the shelves of thousands of Walgreens stores across the country. Earlier coverage from the GLR reviewed the announcement in detail, and examined whether the Pathway/Walgreens partnership might prove to be the catalyst for increased […]

Personal Genomics Follows Pathway to Corner Drugstore; Is Regulation Next?

The direct-to-consumer (DTC) genetic testing marketplace is on the move again. Just last week, in Mapping the Personal Genomics Landscape, I wrote that “predicting precisely which consumer services will be offered and how, if at all, they will be regulated, is impossible. All we know is that personal genomics consumers ten years from now are […]

Mapping the Personal Genomics Landscape

Last week saw the first annual Genomes, Environments, Traits (GET) Conference, in Cambridge, Massachusetts. Timed to coincide with DNA Day 2010, the conference marked one decade since the publication of the draft consensus human genome sequence. The GET Conference was billed as “the last chance in history to collect everyone with a personal genome sequence […]