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'Tech-Savvy' Patient Base Enabled Calif. Hospital to Begin Offering Genetic Screening Service

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El Camino Hospital's recent decision to offer genetic testing and consulting services was enabled by the tech-savvy and relatively affluent Silicon Valley community the hospital serves, according to a hospital official.

The hospital, located in Mountain View, Calif., last week announced it had partnered with DNA Direct to open the Genomic Medicine Institute in an effort to integrate genomics into the healthcare management of its patients.

The rapidly evolving technology within the genetic testing industry and the difficult reimbursement environment for most marketed tests has tempered the integration of personalized medicine into healthcare. However, the location of the hospital in Silicon Valley, a community that is more likely to want to pay for genomic medicine, is perhaps critical to the success of personalized medicine efforts of this kind.

"From an education and economic standpoint, [we serve] folks that work in high-tech [fields and who] tend to be early adopters of technology," Jon Friedenberg, vice president of El Camino Hospital and sponsor of the Genomic Medicine Institute, told Pharmacogenomics Reporter this week. "It's a technologically savvy population that tends to be employed and insured."

Silicon Valley comprises several cities in or around Santa Clara County in northern California. Mountain View has a population of around 70, 000 and a median family income of $103,289. According to Friedenberg, the hospital serves a population that is approximately 40 percent Caucasian, 20 percent South Asian, 20 percent East Asian, 10 percent Hispanic, and 10 percent African American.

According to Friedenberg, currently there are approximately 2,000 marketed genetic tests for disease diagnosis or for gauging response to a drug, and in the next 12 to 18 months that number will double. Recognizing that the practice of medicine would continue to change in this direction, he said El Camino Hospital felt its patients and physicians needed resources to help them navigate the tests that could be clinically useful and improve outcomes.

Through the institute, El Camino Hospital will genetically test patients for their cystic fibrosis carrier status, familial hypercholesterolemia, their risk of hereditary breast and ovarian cancer, hemochromatosis, breast cancer recurrence, and tamoxifen and warfarin response.

For its part DNA Direct, a provider of genomic services, will conduct individual phone consultations for physicians and genetic counseling for patients, as well as create Web-based education tools. The final decision whether to prescribe a test, and what company to order a test from, will be made by a physician, according to the partners.

"In order for physicians to incorporate this technology into medical practice, they need clinical support. In order for patients to make informed decisions about which of these tests and therapies to embrace, they need access to unbiased, state-of-the art genetic counseling," Friedenberg said. "We felt that if we were to provide our physicians with very robust clinical support … then they would have the information they need to make decisions about which of the technologies to incorporate into practice and which not."

Of the nine genetic tests the hospital has begun offering, a few will have to be ordered from specific diagnostics companies, such as Genomic Health's OncotypeDX for breast cancer recurrence testing and Myriad Genetics BRACAnalysis test for hereditary breast and ovarian cancer risk. However, in instances where multiple tests are available, such as for warfarin sensitivity and tamoxifen response, DNA Direct will create web-based educational materials to educate physicians and patients regarding the available technology.

As part of that effort, DNA Direct will compile data from treatment guidelines and published studies on the various testing areas, according to CEO Ryan Phelan. And although physicians will have access to various resources, such as a physicians' portal, Web seminars, and patient surveys to help them match tests to patients, ultimately it will be up to the physicians to decide which company's tests to use for their patients, Phelan emphasized.

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DNA Direct also markets its genomic services directly to consumers, and as such has recently become involved in the debate surrounding online marketing of genetic tests.

New York health regulators warned several consumer genomics firms for marketing genetic testing services directly to state residents. Although DNA Direct never received a cease-and-desist letter from the New York Department of Health, a state health official recently said that the department has determined that DNA Direct is not subject to state regulations as a laboratory [see PGx Reporter 03-18-2009].

DNA Direct is moving more toward working with physicians than with patients. "Our work with El Camino and other partners … in 2009 may be the focus of our attention... to integrate genetics into healthcare," Phelan said.

El Camino Hospital patients will have access to DNA Direct's national call center staffed by certified genetic counselors whose job it will be to help them learn about various conditions and tests. According to Friedenberg, the hospital will pay for the genetic counseling and educational services for the patients.

As part of the service, the labs chosen to provide their tests will bill patients directly. Although the hospital will help patients provide the necessary documentation to their health insurers, reimbursement rates and decisions will vary depending on the individual patient's payor plan, Friedenberg said.

Ultimately, patients will be responsible for paying for those tests not covered by their health insurance.

Indeed, many major health insurers do not cover some of the tests currently being offered through the Genomic Medicine Institute. For instance, although the US Food and Drug Administration has updated the label for the anticoagulant warfarin with genetic risk information, several large insurers have said they will not pay for those tests until studies show genetic testing can improve clinical outcomes and save costs [see PGx Reporter 12-20-2007].

As the Genomic Medicine Institute gets up and running, El Camino Hospital may also find itself in a position to collect clinical-utility data for the genetic tests it administers.

"We are working with our physician advisory group to look at this issue," Friedenberg said. "We think that there will be a significant number of patients who will come to the Genomic Medicine Institute and become early adopters of this technology.

"To the extent that it plays out that way, then we'll be in a position to gather information … that could be useful and that the research community can make some judgments with," he said.

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