Robinson Bradshaw

Topic: CDC

New Diagnostic Guidelines and DTC Testing for Alzheimer’s Disease

Last month, the National Institute on Aging and the Alzheimer’s Association issued new diagnostic guidelines that divide Alzheimer’s disease into three distinct stages, reflecting recent evidence that the disease begins to affect the brain years before symptoms become evident. The expanded definition of Alzheimer’s includes two new phases of the disease: (1) presymptomatic and (2) mildly […]

The Genomics and Personalized Medicine Act Returns to Congress

Meggan Bushee is a student at the Wake Forest University School of Law. This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

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 […]

Transparency First: A Proposal for DTC Genetic Testing Regulation

These are hectic days for the field of direct-to-consumer (DTC) genetic testing. Every week, and sometimes every day, seems to bring a new development. Two weeks ago it was pharmacy giants Walgreens and CVS unveiling agreements with Pathway Genomics to offer Pathway’s genetic testing kits in drugstores nationwide, to which the FDA responded first by […]

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 […]

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 […]

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 […]

A Closer Look at Biobanking of Newborn Blood Spots

Under established state public health programs, hospitals nationwide collect blood samples from the majority of the more than 4 million U.S. newborns each year to screen for genetic and metabolic disorders.  This is widely viewed as a valuable program that can lead to early diagnosis and treatment of potentially serious conditions and is normally controversial […]