Robinson Bradshaw

Topic: personal 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. […]

Digging Deeper into the EEOC’s Final GINA Regulations

As we wrote yesterday, last week the Equal Employment Opportunity Commission (EEOC) issued definitive rules and regulations (pdf) with respect to Title II of the Genetic Information Nondiscrimination Act of 2008 (GINA). In our previous post we offered a brief overview of the new regulations, as well as some preliminary suggestions for employers just now coming […]

A Personal Genomics Update

As regular readers know, in addition to my work as an attorney, in my personal time I am also actively involved with several personal genomics projects. Two of those, Genomes Unzipped and the Personal Genome Project, had major announcements this week. On Monday, the twelve founders and co-collaborators at Genomes Unzipped (including me) published our […]

A Do-It-Yourself Genomic Challenge to Myriad, the FDA and the Future of Genetic Tests

Over the weekend, Steven L. Salzberg and Mihaela Pertea published a short but significant article in the journal Genome Biology. In “Do-it-yourself genetic testing,” Salzberg and Pertea describe the creation of “a computational screen that tests an individual’s genome for mutations in the BRCA genes, despite the fact that both are currently protected by patents.” […]

Getting Serious About Personal Genomics’ Risks

After several months of public drama, the University of California, Berkeley’s ambitious program to introduce its incoming freshmen to personalized medicine reached its denouement in late August. As part of its program, Berkeley offered students the option to participate in genetic testing for three common genetic variants relevant to the body’s ability to metabolize milk […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers

Earlier this week the FDA held a widely publicized two-day public meeting to discuss its planned regulation of laboratory developed tests (LDTs) (for more see: Day One Recap and Day Two Recap). Other than Monday morning, when the FDA presented background information on LDTs and some of the considerations that have pushed the Agency to […]

The Conversation Continues: Recap from Day Two of FDA’s Regulatory Meeting

The second and final day of the FDA’s “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs) brought forth many of the same comments and themes as the first. The primary difference was that, whereas the first day began with some comments from the Agency that provided a few hints about what the FDA has […]

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, […]

Challenging the FDA: A History Lesson for DTC Genetics

Last week the FDA sent letters to five personal genomics companies alleging that the companies are manufacturing and selling medical devices without appropriate FDA review. The FDA’s decision to substantially increase its regulatory oversight of some of the most prominent direct-to-consumer (DTC) genetic service providers has met with a mixed reaction. Supporters of the move […]