Robinson Bradshaw

Topic: SACGHS

Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies. Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least […]

Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn

We reported yesterday on a proposed Patent Act amendment that, if successful, would create a safe harbor for second opinion genetic diagnostic testing. While conceptually simple, the proposed amendment would have left genetic testing developers and providers, patent holders and courts with considerable uncertainty about the safe harbor’s appropriate interpretation and application. Initially offered by Representative Debbie Wasserman […]

House Introduces Patent Reform Proposal to Permit Second Opinions in Genetic Diagnostic Testing

When we last checked in on the state of patent reform back in March, the Senate had just passed the America Invents Act (S.23) or, as it is more commonly known, the Patent Reform Act of 2011 (pdf) by an overwhelming 95-5 vote. Following its passage in the Senate, the legislation promptly stalled in the House […]

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’ […]

Personalized Medicine Regulation Needs More Than Band-Aids

[Editor’s Note: This post originally appeared as a guest column at Xconomy.] Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.” While not accompanied by a press release, or widely covered […]

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. […]

Restricting Gene Patents: A Pro-Market Agenda

This commentary is contributed by James P. Evans, clinical professor genetics and medicine at the University of North Carolina and Editor-in-Chief of Genetics in Medicine. Gene patents have been controversial since they were first granted in the US over two decades ago. The controversy is now reaching a fevered pitch after a surprising US District […]

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.” […]

HHS Pulls the Plug on Genetics Advisory Committee

The clock has run out the Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS). As reported by Turna Ray of Pharmacogenomics Reporter, the committee, which reports to Health and Human Services (HHS) Secretary Kathleen Sebelius, will have its charter extended only long enough to conduct one final meeting next month. According to Ray, SACGHS […]

Breaking: Biotech and the Supremes: Prometheus Follows Bilski to Highest Court (For Just a Moment)

Yesterday the Supreme Court issued its decision in the highly anticipated patent case, Bilski v. Kappos. Contrary to some expectations, the Court decided Bilski on narrow grounds, leaving the state of biotechnology patents largely untouched. Here is part of what we wrote yesterday: Although the Court’s narrow ruling left a direct treatment of the difficult […]