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Novel DNA-Archiving Platform May Spur Greater Genotyping, Expression Research

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A tiny startup plans next month to launch a DNA-archiving platform some believe may help soften a critical roadblock to broader SNP-sharing among governments, academic labs, nonprofits, and big biopharma.

In the process, this technology may also spark a new revenue stream for companies that sell genotyping tools and services to these markets. Trouble is, big pharmas and biotechs — the biggest consumers of these tools and services — have traditionally been loathe to share their DNA.

GenVault, the company that developed the technology, described it as an archive that can store at room temperature DNA samples and attendant anonymized medical and phenotypic data.

“All of the technologies being used right now to get the DNA in the beginning, to amplify it for genotyping it, to archive it, are old, legacy technologies inherited from academic research,” said John Langmore, founder and vice president of commercial development af Rubicon Genomics. “That will not do.”

GenVault said its archive platform can either be sold to big pharma and large academic labs, or it can rent space on its own unit to smaller shops.

The company also hopes to encourage customers to share their data — a move that may buoy genotyping firms, which stand to profit from what may result in a greater volume of DNA samples and SNPs circulating among drug-discovery research labs.

Ultimately, the aim is for academic and public-sector researchers to use the company’s data in in vitro pharmacogenetics studies, and for biopharmas to use them as surrogates for expensive, risky, and time-consuming patient-based trials.

Profit at Room Temperature

Though GenVault won’t discuss the details of its technology, a typical application would look like this: A large health-care facility buys a platform and banks its growing collection of DNA samples onto an expandable library of 384-well plates. The clinic wants to ensure its researchers have access to the samples, but is equally interested in networking those samples to third parties for research — which the clinic sees as a potential new revenue stream.

The technology would allow the clinic to ship its dry samples to these third parties anywhere in the world. These collaborators would then apply whole genome-amplification techniques and “completely replenish that entire plate with DNA,” a GenVault official said.

The size of the general archiving market appears to play in GenVault’s favor. According to the company, some 22 million DNA samples can be archived in the US each year for medical research — a $2 billion market divided among disparate archiving firms, along with individual hospitals and government and academic labs.

The number of NIH fundings for archiving systems grew to 70 in 2001 from 20 in 1997, GenVault said. And though there is no accurate way to measure how much companies spend on DNA banking, GenVault said it believed AstraZeneca has put aside close to $110 million for in-house genetic archiving, and the Mayo Clinic has reserved “a big chunk” of its $80 million budget for genomic databases and samples. Neither companies returned phone calls seeking comment.

To be sure, GenVault has its work cut out for it. The company is just 13 months old, still in stealth mode, and its technology is being beta tested at the CDC, NCI, Mayo Clinic, UCLA, and UCSF. It opened its doors last January with help from a $7 million private-equity round from Domain Associates, and anticipates to close an $11 million round this quarter, according to David Wellis, GenVault’s vice president of business development.

Speaking with SNPtech Reporter, Wellis said a pilot version of GenVault’s archive will be completed next month and will ultimately play three roles in the market: GenVault is currently selling to modest sized institutions space in its own archive, which can hold 1.2 million DNA samples; in the fourth quarter the firm will begin selling modular, scaleable versions of the platform to big pharma and academic hospitals; and it will sell consumables across the board.

GenVault said it hopes the technology will generate more than $10 million in revenue this year, and $100 million by 2006.

An advantage of the technology, the company said, is it can provide greater bang for the genetic buck. For example, DNA from 1 ml of blood archived at room temperature at GenVault’s Carlsbad, Calif., headquarters can yield “hundreds of experiments without degradation from repeated freeze-thaw cycles.” In contrast, traditional DNA-extraction methods may yield 100 experiments and cost twice as much.

But the biggest hope is that clients share their data in a kind of genetic network. This may be a tough sell, especially to traditionally secretive pharmas. To grease the skids, GenVault will use “generous revenue sharing” as an incentive for customers to join the network.

Early market reaction to the technology has been generally positive. Bill Craumer, a spokesman for Illumina, said it “might benefit any research that requires DNA as a sample. Genotyping would certainly benefit, [and] so would gene expression profiling. ...”

Toni Schuh, CEO of Sequenom, added: “A technology that would simplify DNA storage/DNA logistics would be very supportive for any kind of broader DNA analysis applications.”

The trouble — and a puzzling one at that — is that few drug companies will be willing to share their DNA samples for fear of leaking important and proprietary data to potential competitors.

“I was surprised to hear ... that [pharmas] have deals where they share clinical compounds with other companies,” said Langmore, whose company’s technology might “in principle” help re-amplify DNA samples stored at GenVault. “I think drug companies should be very willing to share clinical information or share DNA … because neither of these things is proprietary.”

“What is proprietary to them is their chemical compounds,” he said. “And, if they’re willing to share a chemical compound with other drug companies, anything one step back from that information they also should be willing to share.”

Though few pharmas would discuss their position on sharing DNA with competitors, insiders speculate it is because they believe DNA is an exhaustible resource. But people like Langmore believe these pharmas have it backward. Whereas chemical compounds can be considered finite — when you use up your stash you have to make more, which can be extremely expensive — new genome-amplification technologies like Rubicon’s can turn DNA into a “virtually inexhaustible” resource.

“If they make more efficient use of their bio resources by sharing patient data,” said Langmore, “it seems to me in the long run that is a win-win situation for everybody” — genotyping firms make more money, pharmas avoid lawsuits, and patients get better drugs.

“I think John is right,” Wellis said. “If [pharmas] are making a concerted effort to collect samples and use them in the discovery process, my guess is that they’re not going to share them.”

However, pharma may embrace the GenVault platform in other ways: “They may have lots of ideas for experiments, but to go out and recruit to get their own samples is enormously expensive,” Wellis said. “They can go to us first and see what we have. It’s a lot cheaper.”

“Now there are little disconnected islands of archives, and there are these large national projects,” said Wellis. “But I can see pharmas being large consumers of samples that are in the network,” Wellis added. “I think it could be a very big, sustainable revenue stream.”

—KL

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