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FDA ‘Interested in Collaborating’ With Personal Genomics Firms to Track AEs

Consumer genomics firms could potentially help the US Food and Drug Administration track post-marketing adverse drug reactions, and the agency is interested in partnering with these firms, according to a high-ranking agency official.
Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology, said the agency has already begun preliminary discussions with some undisclosed personal genomics firms “to evaluate the feasibility” of forging such alliances.
In marketing ancestry and disease-predisposition genetic testing services directly to consumers, personal genomics companies are building large electronic databases of clinical and genomic information that the FDA believes can be useful in tracking adverse drug reactions in a post-marketing setting.
“We’re interested in collaborating with them, if I can say that,” Lesko said at a pharmacogenomics conference sponsored by Genome Quebec earlier this month in Montreal. “We’re exploring the possibility that when you do post-marketing surveillance of drugs, and you have hundreds of thousands of genomes analyzed in your database, what would stop you from going back and surveying” whether customers with certain genetic polymorphisms are on certain drugs and have experienced certain adverse reactions?
The FDA’s post-marketing surveillance capabilities were strengthened in September when President George W. Bush signed into law the FDA Amendment Act. As part of the law, drug makers are required to submit results from post-marketing studies to a clinical trial registry. By partnering with personal genomics companies, the FDA would gain access to genomic data that may provide additional insight into adverse drug reactions that have genetic underpinnings.
“We see upside opportunities on the discovery side of genomics to potentially improve post-marketing drug safety through mining large genomic databases that reside in many different organizations, including consumer genomic companies,” Lesko told Pharmacogenomics Reporter this week.
He added that the agency has begun preliminary discussions with some personal genomics firms “to evaluate the feasibility of collaborating if our mission and interests align with each other.”
Decode Genetics Chief Scientific Officer Jeffrey Gulcher told Pharmacogenomics Reporter this week that the FDA convened a meeting about a month ago where several personal genomics firms were invited and asked to educate the agency’s staff regarding their services. At the meeting, the FDA gauged the feasibility and willingness of companies to work with the agency to conduct post-marketing studies.
“There was a general willingness among all parties to work together,” Gulcher said. However, Gulcher noted that such a collaborative project would probably not be possible until companies were at the point where they had genotyped at least 100,000 patients on high-density arrays.

“I also see a potential for harm that [genetic test results] could be misinterpreted by patients. But a lot of this is conjecture at this point.”

Both 23andMe and Navigenics would not comment on any discussions with potential partners. However, both expressed a willingness to partner with the FDA.
Over the past year, 23andMe, Decode Genetics, and Navigenics have begun offering genetic ancestry and disease predisposition testing services to the general public. This has caused concern among physicians’ groups, regulators, and researchers about the quality of the genomic analyses and whether such information could potentially hurt consumers.
“I see a potential for value” in personal genomics companies helping the FDA, Lesko said at the conference in Montreal.
“I also see a potential for harm that [genetic test results] could be misinterpreted by patients,” he added. “But a lot of this is conjecture at this point.
“If [the genome analysis] is done badly, of course that’s bad,” Lesko said. “But we don’t know if it’s done badly. I don’t think anyone has determined if the genome analysis by these companies is any worse than genome analysis done by laboratories.”
To investigate the impact of genomic information on consumers, last month the Scripps Translational Science Institute announced it is joining forces with Navigenics, Affymetrix, and Microsoft to conduct a 20-year study looking at whether knowing certain genomic details will motivate individuals to make lifestyle changes or seek medical care [see PGx Reporter 10-15-2008].
One current potential drawback to an alliance between the FDA and personal genomics firms is that, at the moment, the cost for such services is out of reach for the average consumer, which could limit the diversity of individuals contained in a database.
Among existing commercial genomic-testing firms, 23andMe’s service, at $399, is the least expensive. Navigenics' SNP-genotyping service, which uses Affymetrix arrays, costs $2,500, while Decode Genetics’ program, which uses Illumina’s Human1M BeadChips, runs $985.
New Hope Medical, a clinic that provides “diagnostics and therapies not readily available in conventional medicine,” charges between $475 and $900 for genomic testing for between 12 and 25 SNPs linked to certain conditions. Meantime, a full-genome scan by Knome costs at least $350,000.
One outlier is the non-profit Coriell Institute for Medical Research, which offers to genotype patients for free. Coriell is trying to recruit 10,000 subjects by the end of 2009, and 100,000 volunteers in total, to study the utility of using genomic information to make clinical decisions.
“We not only need to reach those that could afford thousands of dollars of genetic testing, but also those that are in a very minority population who perhaps don’t even have very good health coverage,” Courtney Sill, director of communications at the Coriell Institute for Medical Research, told Pharmacogenomics Reporter recently.
Although no formal collaboration plans between the FDA and personal genomics providers have been announced, the Coriell Institute, with the large, diverse genomic database it plans to build, could potentially be an ideal partner for the agency.
“Efforts to understand the utility of genome information in medical care are critical, especially within diverse populations,” Sill said this week. “We would support efforts by the FDA as further exploration of the usefulness of genome-informed medicine may lead to best practices in the field.”

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