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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Nation’s largest public health district wants to promote personalized medicine

Here’s an unusual development in genetic testing that shows clinical laboratory managers how fast the lab testing marketplace is changing. Two-hospital Palomar Pomerado Health (PPH), California’s largest public health district, recently partnered with 23andMe to introduce a personalized medicine service in North San Diego County.

PPH now sells 23andMe genetic test kits for $399 at express care centers in two grocery stores and an outpatient center. The test kit, Time magazine’s 2008 pick for Invention of the Year, comes with a 30-minute education session by a nurse practitioner.

The sale of kits won’t generate a profit, but PPH expects it to improve business by linking more community members with the diagnostic services of Palomar Pomerado Health. More importantly, pathologist Jerry Kolins, M.D., Medical Director for PPH Clinical Laboratories, said, “It’s about prevention and empowering patients with vital information about their health. This is the future of medicine.”

The 23andMe test uses an individual’s saliva sample to create custom gene microarrays, or gene chips. DNA from the saliva is scanned against the 600,000 single nucleotide polymorphisms (SNPs) in the human genome that differentiate humans from each other, matching known biomarker assays for diseases and traits, explains Rachel Cohen, Director of Communications for 23andMe.

Test results include more than 100 health conditions and inherited traits, including prostate or breast cancer and Types 1 and 2 Diabetes. Results are presented on a secure Website. The genetic profiles can be compared with other family members to create a family tree that indicates which grandparents passed down what health conditions or traits.

Backed by Google, Inc., and drug developer Genentech Inc., Mountainview, California-based 23andMe last fall dropped the price for the genetic analysis from $999 to $399. This low price is significantly below its competitors. For example, Iceland’s DeCode Genetics and Redwood Shores, CA-based Navigenics, each charge $985 and $2,499, respectively for their genetic profiling test.

The lower price came as result of a breakthrough in DNA scanning technology by Illumina, Inc, which provides genotyping for 23andMe. The new Beadchip, called the HumanHap550-Quad+, made DNA testing affordable for the majority of Americans. It also expanded the range of SNPs and rare mutations to make data more relevant than previously.

“This is the first time you can go into a store and buy a DNA analysis kit,” says Andy Hoang, PPH spokesperson. An early of adopter of technologies that improve quality of care and outcomes, he says PPH initiated the relationship with 23andMe.

PPH’s decision to market the DNA tests, however, drew criticism from Muin J. Khoury, MD, director of the Center for Disease Control and Prevention’s Office of Public Health Genomics,  according to an article in HealthLeaders Media. He contends that it’s too soon for these tests to have any value outside of formal scientific studies. Khoury also expressed concerns about “commercial exploitation” of genomics in a 2007 article in the New England Journal of Medicine.

Dr. Kolins disagrees. He pointed out that these genetic profiles help alert individuals to specific diseases and conditions for which they may have a high risk. This knowledge enables them to make better health decisions. “It’s one thing to know that a certain disease runs in the family, but it’s another to translate that risk into numbers,” he stated.. He offered the example of a woman with a propensity for blood clots. In such a situation, this woman may decide not to further increase her risk by taking birth control pills.

Dark Daily observes that the willingness of Palomar Pomerado Health to participate with a company like 23andMe to sell genetic testing kits directly to consumers represents a unique development. It is a first-mover example of a multi-hospital health system taking active steps to offer personalized medicine services as a way to create competitive advantage. Another noteworthy aspect to this development is that Palomar Pomerado Health decided not to establish this genetic testing capability as an in-house service. Instead, it chose to outsource to a commercial company.” – P. Kirk

Related Information:

Palomar Pomorado Health Partners with 23andMe

Concerns Raised Over Health System Offering DNA Tests

23andMe Democratizes Personal Genetics

Two Biotech Firms Pull Ahead in Race for $1,000 Human Genome Sequence