Robinson Bradshaw

Topic: transparency

Is the Genetic Rights Movement Picking Up Steam?

The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible […]

Update: FDA Taking Another (Public) Look at DTC Genetic Tests

Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf). The […]

“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing

It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their […]

The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting

Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all […]

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 […]