Robinson Bradshaw

Topic: Navigenics

Breaking: Congressional Committee Requests Additional Information Regarding 23andMe Sample Swap

Nearly a month ago we reported that the House of Representatives Committee on Energy and Commerce had launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to several of the most prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Today the Committee has followed up with another letter, this one directed to 23andMe president […]

What Five FDA Letters Mean for the Future of DTC Genetic Testing

The FDA has published online letters sent to five personal genomics companies – 23andMe, Navigenics, deCODE Genetics, Knome and Illumina – informing the companies that they are manufacturing and selling medical devices without appropriate FDA premarket review and approval. No surprise that the news that the FDA has sent out letters to some of the […]

Breaking: Congress to Investigate DTC Genetic Testing

The United States House of Representatives Committee on Energy and Commerce today launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to three prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Here is the announcement from the Committee: Today Chairman Henry A. Waxman, Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak, and Subcommittee Ranking […]

FDA Puts the Brakes on Pathway-Walgreens Pairing; What’s Next for DTC?

Well that was quick. On Tuesday, Pathway Genomics and Walgreens announced a partnership to sell a saliva collection kit for Pathway Genomics’ direct-to-consumer (DTC) genetic tests in Walgreens’ thousands of drugstores nationwide. Less than forty-eight hours later, after the FDA repeatedly voiced its concerns about the arrangement, Walgreens has hit the brakes. According to an […]

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 […]

The New York Times vs. Personal Genomics: Much Ado About Not Very Much

Earlier this month, there was speculation that The New York Times was preparing a piece “attacking” the “fledgling industry” of personal genomics (see: Linda Avey Versus the New York Times). The article in question, by reporter Andrew Pollack, was published over the weekend and, in retrospect, it’s hard to see what all the hubbub was about. […]

Why the State of Personal Genomics is Not as Dire as You Think

Another Tale of the Struggle of Personal Genomics, Full of Sound and Fury, Signifying…What? After a while, the personal genomics news cycle can begin to feel predictable. Recently, and not for the first time, there have been rumblings that personal genomics pioneer 23andMe is struggling. The most recent “news” appears to be a December SEC […]

Another Pathway Opens Up for DTC Consumers

In July, Pathway Genomics announced that it would become the latest entrant in the direct-to-consumer (DTC) consumer genomics space. Only now, however, has Pathway begun to return results to its customers, and Kevin Davies of Bio-IT World has a first look at the results. Of note is Pathway’s decision not to report relative or lifetime […]

deCODE Declares. Now What?

If you’re a regular reader of the Genomics Law Report – or the Wall Street Journal for that matter – by now you have probably heard the news: deCODE genetics, Inc. has filed for Chapter 11 Bankruptcy protection. Given deCODE’s recent financial struggles, this latest development is hardly a surprise. Indeed, two months ago, we […]

The Open Secret of DTC Medical Genetic Testing

This is the third of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, A Fundamental Right to Genetic Information (Now More Expensive Than Before) and DTC Genomic Research: […]