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Navigenics Plans to Launch GeneChip-Based Consumer Genotyping Service by Early 2008

Navigenics, a personal genetics firm based in Redwood Shores, Calif., will begin offering consumer genotyping services based on the Affymetrix GeneChip platform “in the next couple of months,” according to a company official.
Dietrich Stephan, chief scientific officer at Navigenics, told BioArray News this week that the company will most likely roll out its service in late 2007 or early 2008.
“We will be launching in the next couple of months but I can’t give an exact date,” he said. While the firm is not planning an advertising blitz to support the rollout, he said he expects personal genetic testing to be the foundation of a new and growing market.
“This kind of service will be very valuable to people,” he said. “Every disease has a genetic component. We are all going to get something, be it cancer or diabetes or Alzheimer’s disease,” he said. “What Navigenics is about is identifying the genetic component of these diseases so that people can do something about it. This is proactive, pre-symptomatic risk assessment,” he added.
Affymetrix President Kevin King disclosed the company’s partnership with Navigenics last week at the UBS Global Healthcare Services Conference in New York.
By partnering with the firm, Affy became the second microarray platform provider to express interest in the nascent market for personal genetic testing.
In August, Illumina announced a similar partnership with Mountain View, Calif.-based 23andMe to provide personal genotyping services to its customers. Under that model, Illumina will most likely provide a custom version of one of its whole-genome genotyping arrays, such as its HumanCNV370-Duo or HumanHap550 BeadChips for use in 23andMe’s service (see BAN 8/14/2007).
Like Navigenics, 23andMe has also pledged to offer personal genetic testing by year end (see BAN 8/7/2007).
Circumventing Genetic Discrimination
According to Stephan, who also heads the Neurobehavioral Research Unit at the Translational Genetics Research Institute in Phoenix, Ariz., Navigenics will solicit customers to send a saliva sample, which the company will analyze on the GeneChip platform. The company will then make the results available to the customer over a secure server and offer genetic counseling on how to mitigate any genetic risks.
Stephan stressed that Navigenics has taken a number of steps to ensure the privacy of its genetic analysis — a feature that he expects to be attractive to customers because it could protect them from potential genetic discrimination, should they be determined to carry certain risk factors.
 “Our business strategy is predicated on [an] absolute requirement to have data be private and be only accessible to the individual and this is the only vehicle to get information to a person in a private way,” he said. “As soon as this information winds up in a medical record, it is available to health insurance companies and there is no federal legislation that protects against genetic discrimination,” he added.
The US Congress is currently considering legislation that could provide protection from genetic discrimination by employers or insurance companies, but the bill, called the Genetic Information Non-Discrimination Act, has yet to pass the Senate. A similar bill was introduced in 2003 but failed to become law. Stephan said he hopes that the current version of the bill, referred to as GINA, will pass the Senate and be signed into law. Aside from that, he pointed out that many states already have legislation defining genetic discrimination.
To provide the kind of security necessary for its service, Stephan said that Navigenics recruited “best-of-breed people” to construct its secure web portal. “From the web and security side we have drawn from the financial sector and we are using security auditing firms to make sure everything is encrypted and cannot be hacked,” he said.
The company itself is constructed differently from technology companies like Affymetrix. CEO Mari Baker joined the firm from the venture capital group Kleiner Perkins Caufield & Byers, which is financing Navigenics along with Sequoia Capital. David Ansley, a former editor at Consumer Reports, is Navigenics’ vice president of editorial, while Amy DuRoss, former chief of staff for California’s Institute for Regenerative Medicine, is vice president of policy and business affairs.

“We are building a new industry here and we recognize that we have to do this right or else the field will be tainted.”

“At the core of this is a very sophisticated team of scientists,” said Stephan. “We have an ethics team, a policy and legislative piece — all these things we built in a gold-standard way because we are building a new industry here and we recognize that we have to do this right or else the field will be tainted,” he said. “This is the dawn of a new era in genetics. This isn’t stuff that should be done willy-nilly,” he added.
Affy’s Role
Also part of Navigenics’ management team is general counsel Stephen Moore, who joins the firm after holding a similar position at Affymetrix. Though the relationship between the firms could be considered close, Stephan stressed that Affy is strictly a technology provider and that Navigenics is free to choose which platforms it uses.
“The company is completely technology agnostic and we will use the best genome-scanning technology available,” he said. “Affy will be a component of that but we are absolutely not wedded to any technology provider. We recognize that the field will evolve and we will evolve with it. Our only metric is reliability and accuracy,” he said.
During Affy’s presentation at UBS, King said that the “field of consumer genetics is really new right now” and acknowledged that Affy is “not quite sure where it will go.” He said that the firm is “realistic” andAffy does not expect the alliance to provide it any significant revenue in the near term.
Nevertheless, “it is clear to us that as healthcare cost soars, the one-size-fits-all approach to healthcare just isn’t going to work either economically or medically,” King said. “We believe that microarray-based consumer genetics is comprehensive, cost effective, scalable, and relatively easy to administer in a large population of patients,” King added.
During the same conference, Illumina CEO Jay Flatley also offered up his vision of where Illumina thinks the market for personal genetics could be headed.
“In the future, we believe this is the kind of information you could carry around on a portable device, maybe your iPhone or your iPod,” Flatley told investors after describing the firm’s partnership with 23andMe. “You’d go to your physician and they’d plug it in, or maybe they’d do it wirelessly, and they would have the ability to prescribe for you the right drug, the right time at the right dose,” he said.

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