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 commentators examined what can be learned from a DTC genetic test. Yesterday, the topic was whether DTC genetic tests are trustworthy, and whether the results can be cause for concern. Today’s topic is the regulation of DTC genetic tests. In addition to several short commentaries, including a much shorter version of the piece below, Carmichael has also posted a lengthy interview with two top FDA officials on the subject of DTC genetic testing regulation.
The column below is an expanded version of what appears over at Newsweek. To see all of the commentaries in Carmichael’s series, click here.]
The recent media attention focused on direct-to-consumer (DTC) genetic tests has left companies, investors, consumers and even regulators scrambling to figure out what comes next.
As the situation stands today, companies and their investors live in a climate of unprecedented regulatory uncertainty, causing delays in the introduction of new products and rendering an already inhospitable economic climate – for both fundraising and sales – even more challenging. Commentators and regulators caution consumers that some DTC genetic tests may be unreliable or, worse, harmful, but have yet to provide clear tools and guidelines for evaluating competing tests. And regulators, including the FDA, must balance their mandate to protect the health and safety of the public with that same public’s desire for autonomy, while also recognizing that innovation is a prerequisite for a healthcare system that must continue to improve outcomes while reducing costs.
Clearly, something must change. But what will that change be? And how will the field of DTC genetic testing evolve? Will DTC be able to continue its current business while regulators and companies engage in protracted negotiations? Will oversight weed out the “snake oil salesmen” and permit legitimate companies to flourish? Will it drive all genetic testing (temporarily) out of the hands of consumers?
Or will the field change in a dramatic and completely unexpected way?
Myriad Gene Patent Litigation Goes Down Under
On Tuesday, June 9, 2010, several plaintiffs, including a breast cancer patient and a cancer advocacy group, sued in a Sydney, Australia federal court to invalidate Myriad Genetics’ patents on the breast cancer susceptibility genes BRCA-1 and 2. According to published reports and comments by Australian patent law experts, the suit substantially tracks the much-publicized one filed in New York by the American Civil Liberties Union. In particular, this suit is also a frontal attack on the Myriad patents, seeking a judgment that genes in isolation from the body are products of nature and thus not patentable inventions.
The factual background in Australia seems a bit different. Myriad has granted an exclusive license to perform BRCA gene tests to a Melbourne company called Genetic Technologies Limited, which is a co-defendant in the case. But GTL has been reported to have “gifted” its patent rights to health care institutions, and not to charge royalties. Nonetheless, the plaintiffs’ lawyers have expressed concern about the possibility of GTL exploiting their monopoly as in the U.S., where the tests cost over $3,000. They note that on two earlier occasions GTL sent letters to hospitals telling them to stop testing. A number of Australian sources have also worried aloud about the implications of the patents for medical research.
Breaking: FDA Moves to Broadly Regulate LDTs
Earlier today, the U.S. Food and Drug Administration (FDA) announced that it will hold a public meeting July 19-20 to “discuss how the agency will oversee laboratory-developed tests (LDTs).” The FDA has made several high-profile announcements over the past month – particularly in the area of direct-to-consumer (DTC) genetic testing – but today’s development, despite its not receiving the same degree of media attention, is likely the most significant development to date.
Why? Until today, the FDA’s recent announcements have involved a series of letters to DTC genetic testing companies, beginning last month with Pathway Genomics and continuing last week with letters to five other prominent DTC companies. Despite all of the attention paid to these letters, the sum total of the FDA’s regulatory focus amounted to only a handful of products. Today’s announcement, on the other hand, declares the FDA’s intent to much more aggressively regulate the entire field of LDTs. While an exact count of the number of LDTs available is impossible, GeneTests.org lists more than 2,000 genetic tests from nearly 600 laboratories, numbers which do not even include genetic tests and other diagnostic products offered DTC. After having been criticized for a policy of case-by-case regulation, the FDA has answered with a move to regulate the entire field of laboratory-based testing.
Read the rest of this entry »
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 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.
