News Roundup: Biotech Funding and LDT Regulation

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Biotech Funding: No Bubble, New Models and the IPO Option. Despite speculation that a recent rise in venture capital investments is indicative of a bubble, to be followed soon by a plunge in available investment capital, venture capital investments in the life sciences are holding steady, both in total dollars and in the size of an average financing. Thus, says Bruce Booth, a partner at Atlas Venture and author of Life Sci VC, there appears to be no bubble to debate, at least not in the life sciences. Booth observes that overall funding is “down considerably from the recent highs in 2007 and 2008” and, while other industries may be experiencing fewer but larger financings, “the data doesn’t support a frothy market for LS venture financings these days.”

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Filed under General Interest, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

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 members were notified this week that Secretary Sebelius and NIH Director Francis Collins had determined that “the major topics related to genetic and genomic technologies had been successfully addressed by the committee through its comprehensive reports and recommendations over the years” and, for that reason, the decision was made “to sunset the committee’s charter.”

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Filed under FDA LDT Regulation, General Interest, Genomic Policymaking, Genomics & Society, Legal & Regulatory

Why 23andMe’s Sample Swap is Actually an Argument In Favor of DTC Genetic Testing

Direct-to-consumer (DTC) genetic testing company 23andMe made news this week thanks to a lab mix-up that left up to 96 customers reviewing genetic data that was not their own. Full details of the mix-up, and analysis of 23andMe’s response, are available from Daniel MacArthur at Genetic Future and Turna Ray at Pharmacogenomics Reporter.

23andMe’s sample swap follows close on the heels of the FDA announcing an investigation into Pathway Genomics and Congress launching an even broader investigation of the three leading DTC genetic testing providers. Not surprisingly, many commentators have pointed to 23andMe’s mix-up as just the latest example of the dangers of DTC genetic testing and further evidence of the need for greater federal regulatory scrutiny.

There are a number of reasons why DTC genetic testing may soon find itself subject to increased federal regulatory oversight. However, 23andMe’s widely publicized data error should not be one of those reasons. In fact, the sample swap, while unfortunately timed, actually presents a compelling argument in favor of the direct-to-consumer model for genetic testing.

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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation