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Navigenics Takes Orders for ‘08 Launch; Signs Partners to Offer Genetic Counseling

Navigenics last week issued a press release trumpeting its official launch and the appointment of a high-profile team of experts to its board of directors and advisory boards, but the firm is taking a cautious approach to entering the still-nascent consumer genomics marketplace, according to a Navigenics official.
“We are really into marketing responsibly,” said Dietrich Stephan, chief scientific officer of Navigenics. “This is medical information, it is not fun frivolous stuff,” he said. “So we are going to have conservative marketing, it will all be done appropriately in clinical settings. This is not a hyped-up product for fun.”
The company has begun taking the first orders for its array-based personal genetics service that it expects to go live in the first quarter of 2008.
Meantime, the company is engaged in building a network of genetic counseling centers that will be able to support its efforts in working with patients.
Stephan told BioArray News last week that the company’s web interface for ordering genetic testing will be operational this week.
“We are just rolling through the beta testing,” said Stephan. “The launch should come next year and we are taking preliminary orders,” he said.
Last month, Stephan told BioArray News that the firm will use an Affymetrix genome-wide SNP genotyping array to scan patient samples for well-characterized variations that predict an increased risk for developing certain diseases (see BAN 10/2/2007).
Navigenics plans to solicit saliva samples from individuals, run the experiments at Affy’s CLIA-approved labs in West Sacramento, Calif., and then perform the analysis at its headquarters in Redwood Shores, finally providing patients with their results and genetic counseling on preventative steps they can take to mitigate the identified genetic risks.
Stephan said this week that Navigenics “absolutely has the chip ready to go.” He added that the ultra-high density array will ”capture the variants we are interested in as well as the variants all the way across the genome so that we can map any new associations that can come down the pipe and get essential information to people immediately.”
According to Stephan, customers will have a pre-counseling session prior to submitting their samples, followed by access to additional genetic counseling after they receive the results of their analysis.
Navigenics will initially offer genomic analysis for 20 diseases, but that will increase over time. Stephan declined to discuss all of the conditions the Navigenics service will initially cover, but said that they would be among the most common sources of mortality and morbidity in the United States, such as cancer, diabetes, and obesity.
To handle the associated privacy risks of performing such analysis, Navigenics has designed a highly encrypted system to relay its results. The firm, however, is not against providing clients with access to all of their genomic information, as long as they agree to assume all responsibility for the data. That would make the patient, not Navigenics, responsible should some entity, such as a healthcare company, discriminate against a patient based on their genetic risks.
“If a person wants access to their whole genome we will do that, but at that point responsibility falls on them,” said Stephan. “We believe that your genome belongs to you, but only you. As long as we have that data, we take our responsibility extremely seriously. If you want data you can have it but you need to be aware of the ramifications of it,” he said.
As an example of these “ramifications,” Stephan said that an individual trawling through the literature might decide to self-diagnose based on his or her genomic information, but that some variants associated with disease are also commonly found in large parts of the population and pose no risk to most carriers. “It’s pretty complicated to establish what is a real association or not and what it means in context,” said Stephan.
Regional Centers of Excellence
Navigenics said last week that is developing relationships with medical institutions, including the Cleveland Clinic in Ohio; Georgetown University in Washington, DC; the Mayo Clinic in Rochester, Minn.; Scripps Health in San Diego; and Partners HealthCare in Boston. The company said that the institutions have expertise in genomic medicine and will support customers in follow-up care and diagnosis.
Additionally, Navigenics said that it has signed agreements with the Mayo Clinic to provide health information on the Navigenics website and with Medscape to develop continuing medical education materials for physicians.

“We believe that your genome belongs to you, but only you.”

Stephan said last week that these different relationships vary by institution, but that the company is interested in developing each partnership in order to provide regional support for its service.
“The general theme is to have regional centers of excellence so that if someone presents with a complex genetic risk assessment, there are trained counselors and trained physicians that know how to utilize it in [an] expert response,” Stephan said.
Navigenics is also working with its clinical partners to perform long-term research on behavioral modification and outcomes. “Do people modify behaviors and stick with behaviors to mitigate genetic risk and does a long-term program like that actually influence outcomes despite genetic risks?” said Stephan. “These are the questions we will be asking.”
Stephan said that without long-term metrics it would be difficult to expect healthcare organizations to provide coverage for a Navigenics test. Currently, customers are expected to pay for the $2,500 service themselves. Stephan told BioArray News’ sister publication In Sequence last week that internal studies suggested that people are willing to pay for these risk profiles out of pocket, and the company is confident that customers will not be deterred by the $2,500 initial price.
After learning more about what customers want to learn, and how to best present the information, “as volume increases and we start understanding how to do it right, we will slowly come down in price point so that everyone can have access, I believe,” Stephan told In Sequence.
Stephan also said that once established, these “regional centers of excellence” could aid in raising awareness about Navigenics’ testing service. The company has not articulated a concrete sales and marketing plan, and Stephan said that the firm will rely on “word of mouth, viral marketing.”
Counting on Expertise
Last week, Navigenics also disclosed the membership of its clinical and scientific advisory boards, as well as members of its internal genetic counseling and policy and ethics task forces and its board of directors.
The membership of each draws heavily on academia, with representation from universities like Princeton, Stanford, and Harvard. Other institutions, such as the Translational Genomic Research Institute, where Stephan serves as director of the neurogenomics division, also have representation on Navigenics’ boards (see people news, this issue).
Stephan said that he expects the experience of its advisors to help it grow what is, at the moment, an uncharted market.
“We went to the best venture capital firms and they intuitively saw the concept and thought it had a real potential to make a difference in this world at a personal level and they personally wanted to be involved,” he said.
Two members of Navigenics’ board of directors come from Kleiner Perkins Caufield & Byers, while another member, former Affy President Sue Siegel, now of VC firm Mohr Davidow Ventures, recently joined the board. Navigenics CEO Mari Baker served previously as executive-in-residence at Kleiner Perkins Caufield & Byers.
“The entire basis of the team we’ve assembled is that we are starting a new industry and it has to be done right the first time. Otherwise, not only will industry be set back for years but patients will be getting bad information or receiving it in a way that it won’t be helpful for them,” Stephan said.

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