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.)
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: Revolution or Minor Uprising?
For well over a year, the DTC genetic testing industry in general, and 23andMe in particular, has been undergoing a shift in the way it characterizes and promotes its offerings. Where they once focused on the educational and recreational features of their services, DTC companies have rolled out an increasing array of tests and reports that appear unambiguously aimed at influencing their customers’ clinical or medical decision-making.
Is the ACCP’s Call for Greater Governmental Regulation of DTC Genetics Premature?
Another player has entered the debate over direct-to-consumer (DTC) genetic testing and come down on the side of greater regulation. In a position statement authored by Barbara Ameer and Norberto Krivoy (pdf), the American College of Clinical Pharmacology (ACCP) proposes greater regulation of laboratory genetic tests generally, DTC advertising of genetic tests, and communication to consumers of genetic test results.
The ACCP’s position paper faults a number of features of the current regime: (i) the FDA does not require premarket review of laboratory-developed tests; (ii) even if conducted in CLIA certified laboratories, the clinical validity of laboratory-developed tests (which includes most DTC genetic testing) is not regulated; (iii) there is no regulatory oversight system for advertising of DTC genetic tests; and (iv) the communication of DTC test results is not mediated through a trained clinician. The ACCP fears that consumers are insufficiently protected in the current unregulated environment, with the result that “at a population level, these collective [negative] experiences may give future genetic testing a poor reputation, and it consequently may not be trusted by consumers.” The ACCP further cautions that the “inequitable regulatory policy regarding laboratory-developed tests [may stifle] innovation in the creation of validated genetic tests.” The position paper does not state, or offer any data suggesting, that any such stigma currently attaches to genetic testing or that innovation is being stifled.
MIT Sues to Shut Down GeneChip Technology — Again
Last week, MIT and E8 Pharmaceuticals, a spinoff co-founded by professors at MIT and Harvard Medical School, filed a second patent infringement suit against Affymetrix‘s GeneChip genetic testing products and services. Last year, MIT sued Affymetrix itself. This time the defendant is Navigenics, a California-based direct-to-consumer genetic testing company. In February of this year, Navigenics acquired Affymetrix’s California CLIA-approved facility, including its microarray-based testing business. It’s possible that the acquisition was part of steps that Navigenics took to address potential compliance issues raised by the state of California with respect to its direct-to-consumer genetic testing services.
In a remarkably succinct (by the standards of patent lawyers) complaint, MIT claims that the GeneChip testing infringes what it calls a “pioneering” 2004 patent on a method of “accurate, reproducible and cost-effective genetic analysis, using minute amounts of sample DNA and a small number of reactants to generate results that were previously impossible.” MIT claims that the infringement is willful and knowing, as evidenced by references to the patent in the Navigenics-Affymetrix asset purchase agreement. Proof of willful infringement exposes the defendant to triple damages. MIT and E8 ask for unspecified damages, to be tripled, as well as attorneys’ fees and an injunction against further use of the patented technology, if Navigenics refuses to take a license. The complaint also references, as evidence of Navigenics’s willful infringement, “its insistence on certain contractual provisions regarding the ‘228 patent and this litigation,” which suggests that the parties have tried and failed to negotiate an agreement.
