Robinson Bradshaw

Topic: Genetic Alliance

The Next Social Media Revolution Will Occur In…Personalized Medicine?

Social media – including Facebook, Twitter and other social networking platforms – are widely credited with fundamentally altering the nature of political discourse and, in some instances, credited as catalysts of political revolution. But social media’s ability to affect change need not be limited to politics, as recent developments in the arena of personalized medicine […]

Weekly Roundup: FDA Regulations, Science Funding and Newborn Screening

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of […]

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 […]

More Myriad: Moving Beyond Single Gene Patents

Unless you have been living under a rock – or, if you hail from the Northeast, living under water – Monday’s decision in Association for Molecular Pathology v. USPTO is no longer new news. Previous coverage from the Genomics Law Report (here and here) reviews Judge Sweet’s opinion and its implications. Moving Beyond Single Gene […]

Evaluating the NIH’s New Genetic Testing Registry

This morning the NIH announced plans to create a publicly accessible registry of genetic tests.  The Genetic Testing Registry (GTR) is expected to be available in 2011 and will contain information voluntarily submitted by genetic test providers.  The news is significant and carries implications for clinical genetic testing laboratories, personal genomics service providers and individual […]

The Texas Newborn Bloodspot Saga has Reached a Sad – and Preventable – Conclusion

Contributed by Ann Waldo, Senior Counsel at Genetic Alliance. In late February, the state of Texas incinerated 5.3 million newborn bloodspots. The background – the Genomics Law Report has had several posts (here and here) about the ongoing situation involving 5.3 million newborn bloodspots in a state biorepository in Texas. Often referred to as “residual” […]

Myriad Genetics, USPTO File Summary Judgment Motions in Gene Patent Case

Two of the defendants in Association for Molecular Pathology v. U.S. Patent and Trademark Office, the frontal attack on Myriad Genetics’ breast cancer gene patents organized by the American Civil Liberties Union, have now filed their own summary judgment motions. (Click through to read the memorandum in support of Myriad Genetics’ motion (pdf) filed on December […]

U.K. Human Genetics Commission Proposes Principles for DTC Genetic Testing Services

Last month, the Human Genetics Commission, the U.K. government’s genetics advisory body, issued for public comment a “Common Framework of Principles” for direct-to-consumer (DTC) genetic testing services. The Principles are derived from earlier reports by the Commission (Genes Direct (2003) (pdf) and More Genes Direct (2007) (pdf)) and seek to: …promote high standards and consistency in the […]

The Scientific Foundation for Personal Genomics: Recommendations from the Joint NIH-CDC Workshop

Last December, some of the true heavyweights in the field of personal genomics convened for a two-day workshop cosponsored by the CDC and NIH to review the science and implementation of personal genomics. Participants included scientific luminaries (e.g., Francis Collins, George Church and Bob Green), personal genomics companies (e.g., 23andMe, Knome, Navigenics, deCODE Genetics and […]

Is the ACCP’s Call for Greater Governmental Regulation of DTC Genetics Premature?

Another player has entered the debate over direct-to-consumer (DTC) genetic testing and come down on the side of greater regulation. In a position statement authored by Barbara Ameer and Norberto Krivoy (pdf), the American College of Clinical Pharmacology (ACCP) proposes greater regulation of laboratory genetic tests generally, DTC advertising of genetic tests, and communication to […]