Robinson Bradshaw

Topic: IVDMIA

More on Pathway and Walgreens: The Price of Visibility and Adding the FTC to the Regulatory Mix

Yesterday, direct-to-consumer (DTC) genetic test provider Pathway Genomics and drugstore giant Walgreens announced a partnership that will place Pathway’s tests on the shelves of thousands of Walgreens stores across the country. Earlier coverage from the GLR reviewed the announcement in detail, and examined whether the Pathway/Walgreens partnership might prove to be the catalyst for increased […]

Personal Genomics Follows Pathway to Corner Drugstore; Is Regulation Next?

The direct-to-consumer (DTC) genetic testing marketplace is on the move again. Just last week, in Mapping the Personal Genomics Landscape, I wrote that “predicting precisely which consumer services will be offered and how, if at all, they will be regulated, is impossible. All we know is that personal genomics consumers ten years from now are […]

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 […]

Five Questions for Personal Genomics in 2010

Death, taxes and January prediction columns: these things are inevitable. So what? A new year offers a convenient—if arbitrary—time to review the year that was and contemplate what lies ahead. Without further ado, here are five of the questions the Genomics Law Report is asking as we kick off 2010. 1. Will the $1,000 genome […]

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 […]