Pathway Genomics Joins the Direct-to-Consumer Genomics Parade

By Kevin Davies

July 15, 2009 | Twenty months after the debut of consumer genomics pioneers 23andMe and deCODEme, San Diego-based Pathway Genomics has launched its own comprehensive direct-to-consumer genotyping service. Company founder and CEO James Plante says Pathway offers several key advantages over its competitors, including the depth, speed and security of the genotyping analysis on offer.

An engineer by training, Plante is a serial entrepreneur with a long-standing interest in developing consumer products. Ten years ago, he became more proactive about his own health when his father was diagnosed with polycystic kidney disease. (He later died from organ transplant complications.)

“That was a wakeup call for me,” Plante told Bio-IT World on the eve of Pathway’s official launch. Plante saw it was easy to go online and order a blood test or a diagnostic test, but that wasn’t the case for genetic information, at least not affordably. “I wanted to find a way for consumers to have access to genetic information at a low cost.” Plante bided his time as prices fell and the technology for targeted genotyping matured.

Plante had surprisingly little trouble raising the capital to get Pathway off the ground late last year, tapping some of the investors in his previous start-up, including The Founders Fund, Edelson Technology Partners, and Western Technology Investment. “It’s a great time to build a new company, particularly in San Diego, where we have depth of expertise in genetics, Illumina down the street, and pretty much everything we need within a few miles,” said Plante.

While Pathway is 20 months late to the party, Plante and colleagues don’t sound daunted by the problem. “It takes a while usually for the major issues to get sorted out, before any new company starts to gather any meaningful new market share,” said Plante. “The market for this is everyone if it’s acceptable and the price is right, and that’s our goal.

“We don’t really believe that the folks that started 18 months ago have any significant market share yet,” Plante continued. “We believe the timing is absolutely right for this. Awareness is increasing, some of the regulatory and other issues have been discussed and there’s pretty good understanding of how companies in this space need to act responsibly and what consumers are interested in.”

According to VP marketing Chris d’Eon, who joined Pathway Genomics from Real Age, Pathway stands to benefit from the efforts of deCODE, 23andMe, and Navigenics, in breaking down various walls. “I’d say we have better science, deeper results, and a better price,” said d’Eon. While the information on some 90 traits and conditions is similar to 23andMe’s service, Pathway is promising more information on Y-chromosome and mitochondrial DNA genotyping. “We’re going deeper than anyone else,” says d’Eon. “We’re going one level deeper.”

Echoing that theme is venture capitalist Kim Davis King, an advisor to Pathway who first met Plante at Smart Drive, which she says exemplified the “faster/better/cheaper model,” starting after the competition but learning from others’ mistakes. “We really understand the consumer… We initially see this as more of a consumer play, but we could switch to the physician channel. We have lots of avenues in terms of distribution channels where we see this playing.”

For the past couple of months, Pathway has been steadily raising awareness with a modest marketing campaign, including several British newspaper sites. It is working with Spark PR, a successful West Coast advertizing agency co-founded by Chris Hempel, a former Netscape executive who is waging her own public battle against a rare genetic disease -- Hempel’s twin daughters suffer from Niemann-Pick Type C, sometimes known as ‘childhood Alzheimer’s.’ “That was the reason she was interested in coming out of semi-retirement and personally taking on another new client -- because this was so personal for her,” said Plante.

Whatever tricks Spark has up its sleeve, Plante says one thing is certain: “We’re certainly not going to start launching Zeppelins,” said Plante, in a playful reference to 23andMe’s latest marketing blitz dominating the Bay Area skyline.

Lab Talk
Pathway’s chief scientific officer is geneticist David Becker, who started in Drosophila research before moving into biotech in 2000 at Neurogenetics, which later became TorreyPines Therapeutics. He worked with the high-profile Alzheimer’s disease (AD) researcher and company founder Rudy Tanzi, isolating putative disease genes and launching drug screening programs. But “in TorreyPines’ infinite wisdom, they decided to quit doing research,” said Becker. “I saw this as a great opportunity to take on one of the biggest challenges in this time of genomics -- trying to translate this information into something that’s useful… in a way that consumers or doctors can act on.”

Pathway’s custom-designed, 10,000-square-feet CLIA-certified lab currently houses genotyping platforms from Illumina, Affymetrix and Sequenom. Pathway vows to be technology agnostic, adopting whichever platforms provide the most value at the lowest cost. “The advantage of our own CLIA-licensed lab is we can quickly adjust the technology we’re using to be competitive, whether it’s to have a broader offering, a better price, or whatever we feel is the important issue to provide a better product to the customer,” said Becker. He stressed the firm’s ability to offer a secure environment for its clients. “We do all the processing here, we do all the genotyping here, we do all the data analysis here,” said Becker.

DNA samples from early adopters will be assayed on one disease-focused custom chip, which will supply information on complex diseases, carrier status for rare diseases, and pharmacogenetics markers. (Further details of the chip specifications will be forthcoming.) In addition, there will be “probably the most extensive SNP-based ancestry test that’s available.” Becker, who has extensive experience using Affymetrix chips, added: “We will offer things that Affymetrix has that Illumina can’t provide at this point.” There are also plans to offer other products on the Sequenom instrument, although Becker would not elaborate.

In common with other consumer genomics firms, Becker oversees an editorial team to review criteria from the latest peer-reviewed genome association studies. That team includes Victoria Magnuson, who trained with Francis Collins and John Todd and is an expert in type 2 diabetes genetics. “We are putting together a white paper that will eventually be on our website that describes our criteria,” said Becker. “We’ve tried to be pretty conservative as to what is acceptable, validated research versus preliminary research markers.”

Retail Therapy
Pathway’s Health Test retails for $249, while the Ancestry Kit is $199. Ordered together, the price is $348, making it the least expensive full-genome consumer genomics test on the market. “The conditions we have on the list are things people are most concerned about,” said Becker, but with particular emphasis on rare disorders, carrier status, and pharmacogenetics. “We’re also trying to put together a package and fit into the Surgeon General’s push for making family history a better tool,” said Becker, the idea being to enable customers to produce a detailed family history that they can take to their physician.

Similar to Navigenics, Pathway features a full-time team of genetic counselors on staff, headed by Linda Wasserman, who formerly directed the UCSD clinical molecular genetics facility. “Some of the things we test for a client should immediately go to a counselor and discuss that with them,” said Becker. However, there will be an extra fee for the counseling service because Pathway is pricing the genotyping chip so inexpensively.

Pathway intends to offer comprehensive information for consumers on a range of genetic disorders and traits, even those that are not ‘actionable.’ “I don’t want to ‘diss’ our competition, but that’s an overused statement,” said Becker. “If you’re reporting on Alzheimer’s disease, that’s not really a condition you can do too much about… We think we can trust people with the genetic information. It’s important to give them the full picture.”

Becker continued: “Obviously we’d love to just give everyone their full genome sequence, and tell them about every little detail. At this point, that’s not really feasible. But we think people will be interested to know everything they possibly can about their overall health and that could motivate them to take action...” Plante also notes that Pathway Genomics will be a partner, like the other consumer genomics companies, for Illumina’s new whole-genome sequencing service.

Other consumer genomics firms have embraced social networking, building patient communities that could become part of the research enterprise, but Pathway’s approach on that score is still evolving. Some of Pathway’s early investors also supported firms like PayPal, Facebook, and Linked In. “Internally we have a lot of discussion about the best way to approach social networking,” Plante said.

Becker indicated the beta tester genotyping is going well, but he had not yet released the data to anybody. Reviewing his own data had provided some motivation to improve his own lifestyle in certain areas, but it was important to keep the genetic results in perspective: “I have a 100% chance of dying,” said Becker. “I’m not really going to fret over a few percent increase in risk over one thing or another.”