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

Clearing a Path for DTC Oversight

In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, we applauded the FDA’s attempt to examine DTC’s unique set of issues separate from other larger and ongoing regulatory conversations, including whether and how to regulate the far more numerous category of laboratory developed tests (LDTs).

So just what should we expect from the next two-days? 2010 saw a flurry of DTC-related regulatory and legislative activity but, ultimately, little in the way of new oversight or concrete guidance. Both regulators (including the FDA) and industry appear to have responded in 2011 with a more measured approach, and this week’s meeting is an opportunity to thoroughly examine the state of DTC genetic testing and develop a clear, sensible strategy for future oversight of the industry.

Over at Genetic Future, Daniel MacArthur has already weighed in, adopting a tone of cautious optimism in advance of the DTC meeting. Meanwhile, with just a few hours left until the meeting kicks off, here are three key points I’ll be emphasizing in my own talk tomorrow morning (slides):


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

The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting

Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all LDTs.

If you’re interested in the details of what was said and by whom you’ll find links at the bottom to all of the relevant transcripts, video feeds and Twitter coverage. For my part, here are the three key take-away points from day one:

Timing. Last week I wrote that it was unlikely that this meeting, or any of the other myriad regulatory and legislative proposals for LDT regulation, would produce a significant shift in the legal and regulatory landscape any time soon. One day of FDA meetings has done nothing to change that opinion.


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

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 most well-known providers of DTC genetic testing products is already making waves. (Daniel MacArthur was the first to point me to the AP story, and Mary Carmichael of Newsweek and Andrew Pollack of The New York Times were among the first to dive into the substance of the letters.)

Below, we will discuss the immediate and long-term implications of the FDA’s most recent regulatory actions for the five companies receiving letters, as well as for the DTC genetic testing industry. First, however, a review of the letters themselves is required. Each of the five two-page letters is signed by Alberto Gutierrez, Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), and follows a similar format throughout. To gauge the impact of these letters we will take them paragraph by paragraph.


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

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

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 certain to have many, many more options than they do today.”

Turns out we only needed to wait a week – not a decade – for the landscape to shift again. Earlier today, DTC provider Pathway Genomics announced that it was partnering with drugstore giant Walgreens to offer its genetic testing service through most of that chain’s 7,500 stores.

Is Walgreens the Tipping Point for Personal Genomics Regulation? At first blush, this might appear to be nothing more than a creative product partnership between a fledgling personal genomics company and a giant drugstore chain. As it turns out, there are early indications that the Pathway/Walgreens partnership could turn out to be a tipping point in the regulation of personal genomics.


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

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 purchasers of genetic tests.

Many details of the GTR are yet to come, with NIH promising to “engage stakeholders – such as genetic test developers, test kit manufacturers, health care providers, patients and researchers – for their insights on the best way to collect and display test information.”  While the GTR isn’t expected to launch until next year, and there is time to fill in the details, the questions and answers section of the GTR’s new website helpfully addresses several of the most important features of the registry.

This post looks at what we know about the GTR today, and considers what the GTR’s ultimate implementation might mean for the development and regulation of genetic testing.  (Note that the inset orange questions, and the text that immediately follows each question, is taken directly from the GTR question and answer page.)


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

Five Questions for Personal Genomics in 2010

Personal Genomics in 2010Death, 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 live up to the hype? Affordable whole-genome sequencing is coming, possibly as early as this year depending on whom you ask. But when the day inevitably arrives, after the media frenzy has subsided, will the $1,000 genome prove anti-climactic?

Whole-genome sequencing is a means to an end and not an end in itself. The understandable excitement surrounding Complete Genomics’ November announcement that it had sequenced three genomes for an average cost of $4,400 often neglected to focus on what the price tag did not cover: the substantial costs associated with interpreting the genomic data.

For genomics researchers, the falling cost of whole-genome sequencing is a continuing cause for celebration, enabling increasingly ambitious research projects. But the success of personal genomics, which is what really matters to consumers, patients and healthcare providers, requires more than inexpensive genomic data. The real breakthrough in personal genomics will come when we can offer individuals affordable access to their whole-genome sequence as well as to the genomic tools and knowledgebase necessary for those individuals to put that data to use.


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Filed under Direct-to-Consumer Services, General Interest, Genomic Policymaking, Genomic Sequencing, Genomics & Society, GINA, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation