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California Outpatient Centers Offer 23andMe Genome Scans for Preventative Healthcare

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23andMe and Southern California's Palomar Pomerado Health system have begun offering genetic screening services at several local outpatient healthcare centers in an effort to encourage preventative healthcare.

The partnership marks the first time 23andMe's genetic-screening service is being offered outside the company's website and through a healthcare facility.

"PPH has taken an active role in promoting preventive healthcare," 23andMe and PPH said in a statement. "Because genetics is a major factor in the development of health conditions and diseases, PPH believes that individualized genetic information can help members make more educated lifestyle and healthcare decisions, as well as helping physicians better understand their patients' health."

PPH, a public health care system serving San Diego, will offer 23andMe's Personal Genome Service for $399 at two express-care retail health centers in Escondido and Rancho Penasquitos, as well as at the Pomerado Outpatient Pavilion in Poway. Those who purchase the service at these facilities will also receive a 30-minute educational session with a PPH nurse, who will answer questions about genetic testing using educational materials developed by 23andMe.

"Referrals are provided to genetic counselors, but the education session is not genetic counseling," Orlando Portale, PPH's chief technology officer, told Pharmacogenomics Reporter this week. "We believe that 23andMe has done an outstanding job of describing the test results and providing a wealth of patient education materials on the website that is a great benefit."

Though the partnership marks the first time 23andMe is offering its service through a healthcare facility, the Terms of Use portion of the firm's website continues to inform customer that the genetic information generated and sold under its Personal Genome Service "is based on scientific research, and cannot be relied upon at this point for diagnostic purposes.

"Genetic discoveries that we report have not, for the most part, been clinically validated, and the technology the laboratory uses, the same technology used by the research community, has also not yet been validated for clinical utility," 23andMe tells customers.

Although its genetic testing services will be used to make medical decisions, 23andMe maintains its service is for "research and educational use only."

"We are not planning any changes to our terms of service as a result of our partnership with PPH," a 23andMe spokesperson told Pharmacogenomics Reporter this week. "As stated in our terms of service and elsewhere on our website, we encourage our customers to seek the advice of a physician or other appropriate healthcare professional with any questions they may have regarding their data or their health.

"The partnership with PPH is consistent with our goals of furthering understanding of genetic information," the spokesperson added.

23andMe is not the first consumer genomics firm to partner with a healthcare group. Genomic services provider DNA Direct partnered with Mountain View, Calif.-based El Camino Hospital in March to open the Genomic Medicine Institute in an effort to integrate genomics into the healthcare management of patients [see PGx Reporter 04-01-2009].

Navigenics earlier this year launched a cheaper stripped-down version of its genetic screening service through MDVIP — a collective of physicians spread across 25 states and Washington, DC, who practice preventative and personalized healthcare — with the hopes that genetic information would be incorporated into people's annual medical exams [see PGx Reporter 02-04-2009].

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Like 23andMe, Navigenics also states in its Terms of Use that "the contents of [its] site, including any risk estimates or other reports generated by the Services … are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis, or treatment."

Without clear federal regulation guiding consumer genomic services such as 23andMe and Navigenics the line between medical practice and education is currently murky.

For example, after California health regulators last year warned 23andMe and other consumer genomics firms to stop directly marketing genetic services to state residents, 23andMe maintained that it was not selling a medical service but rather giving people access to their genetic information. To support that stance at the time, 23andMe told Pharmacogenomics Reporter that the company prefers to call those who partake in its services and research projects "customers" and not "patients" [see PGx Reporter 06-04-2008].

In partnering with PPH, the distinction between "customers" and "patients" becomes more blurred.

In the release announcing the deal, 23andMe and PPH said "patients" who purchase the $399 service will receive a 30-minute personal education session with a PPH nurse. In the same release, Jerry Kolins, PPH Laboratories' medical director, said that since "genetics significantly impacts a person's risk for developing certain diseases, having access to genetic information can be useful for both patients and physicians in helping to prevent health problems down the road."

For its part, PPH seems unperturbed by the fact that certain aspects of 23andMe's service are not clinically validated by its own admission.

"PPH realizes that this is really the beginning of the personalized medicine revolution. There are clearly pieces of information in the 23andMe service that are well accepted and clinically useful," PPH's Portale said. "The fact that the service is not a diagnostic does not mean the information should not be used for preventive health care.

"Genetic information, like information about a person's lifestyle — such as diet, exercise, and smoking — which also is not diagnostic, can bear on their risk for disease and health care providers may wish to refer to this information when managing an individual's care," Portale added.

The 23andMe Personal Genome Service provides information about how markers in a person's genome affects his or her propensity for developing more than 100 health conditions and inherited traits, including prostate cancer, type 2 diabetes, venous thromboembolism, and cystic fibrosis. The company also tests for SNPs believed to influence how people respond to certain medications, such as the anticoagulant warfarin.

"As more genetic discoveries are made and the clinical impact of these correlations is more fully understood, physicians and patients will be better equipped to incorporate genetic information into health care and lifestyle decisions," 23andMe co-founder Linda Avey said in the statement. "PPH recognizes that providing their patients with their genetic information now is the first step on this path to more personalized health care and prevention."

PPH, the largest public health district in California, serves approximately 500,000 people, which represents around 18 percent of San Diego's population. The average household income in 2007 in the region was more than $87,000, and more than two-thirds of residents have more than a high school education.

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