Personal genetics company 23andMe launched a new online effort last week to recruit its customers to participate in studies trying to shed additional light on genetic predispositions for certain diseases and adverse drug reactions.
The initiative, called 23andWe, aims to improve the quality of patient data that enter pharmacogenomic-based clinical trials organized by 23andMe; advance the development of tailored drugs; and encourage regulators and medical groups to use genetic information in their medical decision making.
“By directly involving 23andMe customers in the company’s research projects, the goal is to conduct large-scale studies powered by a web-based community of diverse individuals who are willing to share information (on a confidential basis) about their health and other personal traits,” the company said in a statement last week.
The research agenda for 23andWe will be established as 23andMe evaluates research proposals submitted to the company. After a proposal is approved, 23andMe researchers will gather phenotypic information from volunteering customers through online surveys. Once they compile these, the researchers will analyze them in order to determine the genetic underpinnings for certain diseases.
According to the company, all 23andMe customers can participate in the project by filling out the online surveys, and in exchange will have access to the same services offered under the personal genomics program, under which customers have the ability to compare their genome to those of populations around the globe, hone in on particular genes to learn about their associations to certain traits, trace different inheritance traits, and learn about various genes’ associations with certain diseases.
Under the personal genome service, 23andMe customers send saliva samples to a contracted CLIA-certified laboratory that genotypes their DNA. “The chip used in our process is the Illumina HumanHap550+ BeadChip, which reads more than 550,000 SNPs plus a 23andMe custom-designed set that analyzes more than 30,000 additional SNPs,” the company said.
23andMe will decide on a case-by-case basis whether to recruit patients outside of its customer base for a given study.
The first 23andWe project will focus on Parkinson’s disease through a partnership with the Parkinson’s Institute of Sunnyvale in California. The project plans to use web-based communities to recruit patients for clinical research with the ultimate goal of increasing the quantity and quality of data collected.
“Once 23andMe and the Parkinson's Institute develop the validated web-based forms that will be used for the gathering of clinical and risk-factor information, we plan to do a Parkinson's [genome-wide association study] to try to discover the specific genes associated with Parkinson's, as well as the environmental factors that contribute to its development,” 23andMe co-founder Anne Wojcicki told Pharmacogenomics Reporter this week.
“We plan to do a Parkinson's [genome-wide association study] to try to discover the specific genes associated with Parkinson's, as well as the environmental factors that contribute to its development.”
As part of the study, participants will be enrolled through the Parkinson's Institute and genotyped through 23andMe’s personal genome service. The Michael J. Fox Foundation will pay for the genotyping, according to 23andMe.
Big Pharma End Run
With the launch of its web-based genetics research arm, 23andMe appears to be evolving into a so-called NewPharmaCo, a new breed of life-sciences companies focused on developing pharmacogenomics-based treatments and structured to garner leadership in the market through virtual healthcare networks.
These NewPharmaCos, a term which appeared in a recent Deloitte report analyzing the pharmaceutical industry, threaten to beat out big pharmas by developing genotype/biomarker-driven drugs in smaller disease markets; by using molecular diagnostics to resuscitate off-patent, lower-efficacy drugs in smaller, targeted populations; and by establishing virtual healthcare networks to forge relationships with patients, starting from predisposition testing to disease treatment [see PGx Reporter 05-21-2008].
23andMe said it plans to regularly inform its customers about 23andWe projects and how they can become more involved in the company’s genetics research.
“We plan to work with the genetic counseling and medical communities as genetic research progresses and more data is disseminated to ensure people are properly educated about their genetic information,” Wojcicki said.
Last year, 23andMe was one of several firms to launch direct-to-consumer genotyping services with the promise of gleaning their risk for developing complex, and sometimes fatal, diseases. But as these types of services multiplied, doctor and patient groups became increasingly concerned that existing federal regulations for these services is confusing and may be used inappropriately [see PGx Reporter 05-07-2008].
However, 23andMe has maintained that it is not selling a medical service but rather giving people access to their genetic information. To support that pitch, the company prefers to call its 23andWe study participants “customers” and not “patients,” the company told Pharmacogenomics Reporter.
According to Wojcicki, 23andWe aims to advance research into individual gene-based disease risk, as well as the genetic foundation of adverse drug reactions.
“We are very interested in studying adverse events,” Wojcicki said. She cited the experience with Merck’s Vioxx to note that “even though a large number of people relied on Vioxx and used it safely, the drug was taken off the market because it caused problems for a small percentage of users.
“If we can find a genetic basis for the difference in reactions to certain drugs, physicians will then be able to determine which individuals can use the drug safely and which cannot,” Wojcicki said.
Another reason for launching 23andWe is to generate the clinical data that will encourage medical and regulatory bodies to incorporate genetic information into clinical healthcare decision-making.
“For instance, if we discover that individuals with certain genotypes are more or less likely to have an adverse event with a specific drug, ultimately the [US Food and Drug Administration] could [encourage] drug companies [to] incorporate such information into labeling for drugs, and enable the medical community to use the information to tailor drugs to individuals” less likely to suffer an adverse event, Wojcicki said.
Last October, the FDA and a collection of industry and academic partners kicked off the Serious Adverse Events Consortium, a collaborative effort that hopes to identify genetic markers that might be used to identify patients at high risk for adverse reactions to particular drugs [see PGx Reporter 10-03-2007].
According to Wojcicki, 23andMe hopes to collaborate with various FDA programs to better understand the genetic causes for adverse events.