Robinson Bradshaw

Topic: genetic testing

A Constitutional Challenge to Alaska’s Genetic Privacy Statute

As part of its defense of a class action lawsuit that began in 2014, a genetic genealogy company (or DNA ancestry company as they are sometimes called) is challenging the constitutionality of the Alaska Genetic Privacy Act, arguing that the statute’s provisions are unconstitutionally vague. The State of Alaska is intervening in the lawsuit to […]

The FDA and DTC: Time to Set the Record Straight

Earlier this month an FDA advisory panel met for two days to consider a range of issues pertaining to clinical direct-to-consumer (DTC) genetic testing. The non-voting advisory panel’s discussion (pdf), including whether certain genetic tests or categories of tests should be made available only through qualified healthcare professionals, sparked considerable controversy (see here for a […]

The FDA and DTC Genetic Testing: Setting the Record Straight

Earlier this week, I attended a public two-day meeting of the FDA’s Molecular and Clinical Genetics Panel (“MCGP”) in Gaithersburg, MD.  The meeting was not particularly well attended (approximately 100 people were in the room) but the topic of the panel’s deliberations – how to appropriately regulate direct-to-consumer (DTC) genetic tests – has sparked intense […]

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’ […]

MLB Takes Another Swing at Complying with GINA

In 2008 Congress passed the Genetic Information Nondiscrimination Act (GINA). Although GINA is arguably “the first civil rights bill of the 21st century,” we have consistently reminded Genomics Law Report readers that passing GINA into law was only the first step. As is the case with any piece of new legislation, even after a law […]

The Business Effects of Regulatory Uncertainty in Genetic Testing

The business of genetic testing has progressed rapidly, if unevenly, over the past several years. Like any business based on new and rapidly developing science, the promise of new products and markets is counter-balanced by the obstacles of developing commercial products from raw science, fostering markets for those products, constructing profitable business models and overcoming […]

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 […]

What ELSI was New? Plenty.

From October 5 to December 8, 2009, the Genomics Law Report featured a series of thirty-six guest commentaries by industry, academic and thought leaders in the fields of genomics and personalized medicine. Entitled What ELSI is New?, the series, which we have organized into an e-book (pdf), asked each contributor to briefly respond to the following question: “What do […]

CSHL and a Brief Survey on Genetic Testing for Psychiatric Diseases

As many readers are probably aware, Cold Spring Harbor Laboratory is presenting its second meeting on Personal Genomes next week. Freelance science writer and blogger Ginny Hughes will be speaking about the science and attitudes of genetic testing for psychiatric diseases. She’s prepared a very short survey on the topic so please help her out with a […]

The Importance of Balance in Evaluating DTC Genomics

Earlier this week the New York Times published a generally alarmist and one-sided piece (“Buyer Beware of Home DNA Tests”) advising consumers to steer clear of direct-to-consumer (DTC) genetic testing and genomic services providers. The Times piece advises consumers to opt instead for a certified medical geneticist or genetic counselor even as it acknowledges, in […]