GenVault wants to bring biological samples in from the cold. For decades, the biological samples used to diagnose or study disease have been stored in freezers, which use a lot of electricity. GenVault markets dry-storage technologies that allow scientists to store samples—such as DNA from a blood test—at room temperature.

GenVault CEO David Wellis argues the company’s technologies free up lab space and are better for the environment. He says that one of GenVault’s desktop storage units can hold as many samples as an average-size lab freezer, which has the same carbon footprint as five automobiles. Freezers have another major drawback: a single power failure can destroy years of work.

Wellis says the time is right for his company. The use of genomic analysis for disease diagnosis, scientific research, and forensic criminal investigations is exploding, thanks in part to technical advances that enable the swift decoding of genes. All these genetic tests start with biological samples, such as blood, urine, or spit. The RAND Corp. recently estimated that more than 307 million tissue specimens are stored in the United States, with more than 20 million specimens added each year. That means more and more freezers are taking up lab space, and running up electricity bills.

GenVault, which is based about 26 miles north of San Diego, in Carlsbad, CA, estimates that sample transport and storage represents a $4.5 billion business opportunity. It is also an area in which innovation has been lacking. “All the technical development has occurred in sequencing and informatics,” says Wellis. “The management of samples has seen no innovation. It is a gaping hole.”

GenVault got started in late 2001 to fill that perceived hole. The venture-backed company has raised more than $32 million to date, and has numerous customers, including the national Centers for Disease Control and Prevention, Genome Québec, and Amgen. The company expects to soon announce a new diagnostic lab customer that expects to store 750,000 samples using GenVault’s technology. Wellis says GenVault, which has 40 employees, could breakeven by the end of next year.

The company markets two products. One is a chemically treated paper that preserves bits of whole samples, such as blood or spit; the other a salt-like mineral matrix that preserves purified DNA. Here is how GenVault says …Next Page »

Comments | Reprints | Share:        

The work leading to Brent Gaylord’s dissertation on using light-emitting polymers to detect bits of DNA was more far more than an academic exercise. His initial paper, and the intellectual property that was subsequently generated, directly lead to the creation of San Diego’s Sirigen.

Gaylord co-founded Sirigen six years ago to enter a business plan competition at UC Santa Barbara, where he earned his doctorate in materials science. Sirigen won the contest, and has been moving forward ever since. Today the venture-backed diagnostics technology startup has 15 employees and formal collaborations with five companies. Gaylord, the company’s chief scientific officer, says it is too soon to identify the collaborators but assures me that “they are names you’ve heard of.” The first product using Sirigen’s technology is expected to reach the marketplace sometime next year, he says.

Sirigen has no intention of producing its own line of complete diagnostic kits or detection devices. Instead the company is pursuing an “Intel Inside” strategy of getting its technology into diagnostic products made by others. Sirigen’s polymers use high-sensitivity fluorescence (HSF) to enhance the ability of conventional assays to detect specific antigens, proteins or bits of DNA. Gaylord says the technology can detect smaller quantities of target substances than conventional tests.

Also, the technology can offer improvements over conventional immunoassays—tests that commonly use an enzyme linked to an antibody to detect the presence of drugs or pathogens, such as the viruses that cause AIDS or hepatitis. Gaylord says existing immunoassays can detect just one target at a time, but an assay that alternatively incorporates Sirigen HSF technology can sense multiple targets with little loss in accuracy.

The result is faster, and potentially cheaper, testing.

Gaylord says the technology is generating interest because it has numerous applications, ranging from biological threat detection to drug discovery. With funding from the Army, for instance, Sirigen successfully demonstrated the ability of its technology to detect …Next Page »

Comments | Reprints | Share:        

Boston-based synthetic biology startup Ginkgo BioWorks has been selected as one of two entities to support a Scottish initiative to find better ways to assemble synthetic DNA, according to ITI Life Sciences, which has committed $4.1 million to the effort. ITI Life Sciences is a unit of ITI Scotland, a firm that was formed in 2003 by the government of Scotland to help grow industries in the country such as life sciences, energy, and digital media. Ginkgo BioWorks was launched in 2008 by five MIT scientists and researchers to make the construction of synthetic DNA easier and faster, according to its website.

Comments (1) | Reprints | Share:        

Biological Dynamics, an early stage cancer diagnostics company founded by UC San Diego grad student Raj Krishnan, has raised more than $47,000 in startup capital by winning cash prizes in business plan competitions and other academic contests. Now Krishnan tells me he’s one of 16 finalists in a global competition for university and business-school students that provides a minimum seed investment of $250,000 in venture capital funding for the first-place team.

Final presentations are set for today, using Web-based technology from San Jose, CA-base Cisco Systems to enable each of the finalists to discuss their business plans with a San Jose-based panel of seasoned investors from Menlo Park, CA-venture capital firm Draper Fisher Jurvetson (DFJ), its Global Network of Funds, and Cisco. The winner of the inaugural DFJ Cisco Global Business Plan Competition will be announced in a 30-minute webcast this evening by the organizers, DFJ and Cisco.

Biological Dynamics is developing a multi-cancer diagnostic tool based on a discovery Krishnan made while conducting experiments in high-conductance dielectrophoresis. The technology uses a microelectrode array to detect “high molecular weight” DNA, an early cancer biomarker, directly from whole blood samples. Amid a continuing drought in startup funding, Krishnan began raising capital for his medical diagnostics company by systematically entering symposia, poster sessions, and business plan contests that offered cash prizes and services to winners.

To make the finals in the DFJ Cisco competition, “We were selected from over 1,000 business plans worldwide,” Krishnan says in a recent e-mail. “This is the largest and biggest single payout business plan competition there is (as far as I know).” Biological Dynamics was the only team from San Diego to make the finals.

“Winning this competition would enable our company to get enough money ($250,000) to really start our business and begin construction of a final prototype,” Krishnan tells me. “We are already in talks with several companies about what our device can do, but the hardest money to come by in this economy is seed investment.”

Krishnan says VCs and other potential investors prefer “to invest in companies that are already at Series A or greater, because they want to minimize risk while maximizing reward. We feel that this competition is one of the few ways left right now that can enable translation of successful business ideas that people might be reluctant to invest in because of the economy.”

In a recent joint statement, DFJ and Cisco say the 16 finalists represent universities and business schools throughout the United States, Brazil, Russia, India, China, and Israel. “Our review process considered the management team, technical innovation, addressable market size, competitive positioning, barriers, capital efficiency, and financial projections,” the sponsors said.

Xconomy’s Juha-Pekka Tikka (who’s returning home to Helsinki today) profiled Krishnan and Biological Dynamics last month after the 27-year-old bioengineering doctoral candidate won the spring presentation in the UCSD Entrepreneur Challenge. The first place winner of the UCSD business plan competition took home $25,000 in cash and $15,000 in legal services from the San Diego office of the DLA Piper law firm.

Krishnan says he’s won 14 awards for a total of $47,240 in cash and services since 2007, when he got just $15 for a third-place showing in a UCSD Bioengineering Graduate Student Symposium.

Comments (1) | Reprints | Share:        

IntelligentMDx, a Cambridge, MA, startup developing DNA- and RNA-based tests for a range of human diseases, announced last week that it has raised an additional $3 million from a group of unnamed, non-venture investors. The new funding brings the startup’s total capital pot to $26.5 million.

Comments | Reprints | Share:        

Knome, a personal genomics startups located in Cambridge, MA, announced today the launch of its newest product, a partial genome sequencing package called KnomeSELECT. The service will cost $24,500 for individuals, but is discounted to $19,500 per person for couples and family groups. The firm’s more comprehensive whole-genome sequencing service, KnomeCOMPLETE, costs $99,000. Rather than decoding a person’s entire genetic blueprint, KnomeSELECT looks only at the exome, the protein-coding regions of the DNA.

Comments | Reprints | Share:        

NABsys, a Providence, RI-based startup focused on advanced DNA sequencing technology, has raised $4 million in a Series A round of financing intended to help it develop a novel approach of using electronics to potentially sequence the human genome quicker and less expensively than available methods. The firm, which was expected to reveal the closing of the new financing this morning, is among a host of companies and academic groups around the world in hot pursuit of transforming the historically time-consuming and costly process of sequencing DNA into methods that make the technology fast and cheap enough to be used more routinely in healthcare.

Providence venture firm Point Judith Capital led the new round, which included investments from previous seed-round backers such as the Slater Technology Fund, a state of Rhode Island-funded venture group, according to NABsys. As part of the financing, Gina Raimondo, a general partner at Point Judith, is joining the board of directors at NABsys. The infusion of private capital also builds on more than $1 million in grant funding the startup and its inventors at Brown University were awarded in 2007 from the National Institutes of Health’s National Human Genome Research Institute.

A major theme in the field of genetic sequencing has been to reduce the cost of sequencing an entire genome to $1,000—a scientific goal that’s been dubbed the “$1,000 Genome.” In New England, firms such as Cambridge, MA-based Helicos BioSciences (NASDAQ:HLCS) and Roche-owned 454 Life Sciences, of Branford, CT, have already commercialized sequencing machines that have helped close part of the gap between a whole-genome sequencing cost of more than a $1 million just several years ago to the $1,000 goal. Helicos, for example, says its machines can sequence an entire genome for less than $100,000. Now NABsys aims to close the gap even further—and even eclipse the $1,000 target with a sequencing system that could potentially sequence a person’s DNA for less than $100 in under an hour, company president and CEO Barrett Bready tells me.

“All of the stuff that we are doing here is with an eye toward having a clinically relevant tool,” Bready says. “In our minds, that means something with the speed and cost to be used routinely in clinical care, but most importantly the accuracy.”

NABsys calls its approach “electronic, solid-state DNA sequencing.” In the process, DNA fragments are supposed to flow into nano-sized pores in a silicon chip. As the molecules of DNA pass through the pores, the system detects changes in the electrical current caused by probes attached to the DNA. The company is developing algorithms to reconstruct the data, generated from the electronic detection of multiple DNA fragments, into the sequence of a whole genome. (NABsys shows how the technology works in two videos found on its website.)

Many commercial sequencing systems rely on optical readings to record the sequence of DNA. Yet NABsys believes that the use of electronic detection will …Next Page »

Comments (1) | Reprints | Share:        

Illumina (NASDAQ:ILMN), a San Diego-based provider of genetic and biological research tools, says it has formed an commercial alliance with Oxford Nanopore Technologies, an Oxford, England, developer of a single-molecule DNA sequencing system. Illumina will invest $18 million in Oxford as part of the deal, under which Illumina will exclusively sell and distribute Oxford’s experimental system worldwide.

Comments | Reprints | Share:        

Frank Reynolds, the CEO of Cambridge, MA-based InVivo Therapeutics, says he still feels pain in his lower back when he steps off a curb. The pain stems from the spinal cord injury Reynolds suffered in an auto accident in 1992. It’s no coincidence that today he is running a medical technology firm with an implant that could prevent some cases of paralysis.

This week InVivo launched a second study to test its polymer-based device—implanted at the site of the spinal cord injury—in monkeys, Reynolds says. If successful, the study could provide enough evidence to get the “green light” from the FDA to begin human testing next year. Reynolds also aims to raise $15 million in a Series A financing round in the next few months to fund the company through human clinical trials and the cost of a factory to mass-produce the device. (Thus far, the company has raised nearly $3 million from family and friends.)

“The rest of the world is focused on regeneration.” Reynolds says. “We take a different path than the rest of the world.”

Initially developed in the lab of prolific MIT inventor Bob Langer—a scientific advisor of InVivo—the company’s fingertip-sized device is intended to be implanted within days of a spinal cord injury to limit tissue damage, or secondary injuries, that most often cause patients to become paralyzed. The device is made of biodegradable polymers engineered to dissolve in the body in weeks. Reynolds says the fabrication and use of the materials and not the materials themselves make the device unique.

Today’s limited options to treat spinal cord injuries include stabilizing patients’ bodies to prevent further damage, anti-inflammatory drugs, and, if needed, surgeries to decompress injured areas and to remove bone fragments.

With mixed results, many experimental treatments for spinal injuries have focused on treating damaged neurons. Hopkinton, MA-based Alseres Pharmaceuticals (NASDAQ:ALSE), for example, is developing a …Next Page »

Comments (5) | Reprints | Share:        

It’s an impressive and even intimidating group. Two world-renowned professors, one from MIT, the other from Harvard Medical School; MIT itself; and the lawyers who won a $612 million settlement from Research in Motion, the Blackberry folks. They’ve joined forces in a patent lawsuit, filed without fanfare last week in federal court, against one of biotech’s pioneers: Santa Clara, CA-based Affymetrix. No dollar amount was named in the suit. But analysts and the plaintiffs, who are seeking treble damages, say the technology in question is vital to much of Affymetrix’s business—an indication that many millions of dollars are at stake.

What may also be at stake is a long-standing relationship that MIT has with Affymetrix (NASDAQ: AFFX)—a maker of microarrays and associated tools for analyzing genes—through the Broad Institute, a Cambridge, MA-based biomedical research institute jointly run by MIT and Harvard. The collaboration, focused in part on the very technology at the core of the patent suit, could put MIT in a bind—or at least create the appearance of a conflict—as the case progresses.

The named plaintiffs in the lawsuit, filed on July 1 in U.S. District Court in Massachusetts, are MIT and a newly formed company called E8 Pharmaceuticals. The firm is the brainchild of MIT biologist David Housman, a pioneer in forensic DNA analysis whose co-invention is at the nub of the litigation, and Richard Mulligan, a MacArthur Prize-winning biologist formerly at MIT and now at Harvard Medical School. (Mulligan, an Xconomist, serves on ImClone’s board and was nominated, but not elected, to Biogen Idec’s board as part of billionaire investor Carl Icahn’s attempted takeover of the company.) The plaintiffs’ lawyers are from Wiley Rein, the Washington, DC-based law firm that represented patent-holding company NTP in its infringement suit against RIM; that suit ended with in the BlackBerry firm settling in 2006 for $612 million.

At issue in the suit against Affymetrix is U.S. patent No. 6,703,228. In their complaint, E8 and MIT hail the technology covered by the patent as a pioneering discovery in genotyping and DNA analysis that “enables users to perform accurate, reproducible and cost-effective genetic analysis, using minute amounts of sample DNA and a small number of reactants to generate results that were previously impossible, even in specialized high throughput centers using many thousands of different reactants.” The patent was awarded to MIT in March 2004, with Housman and his group named as the inventors.

The lawsuit alleges that some of Affymetrix’s GeneChip (the firm’s trade name for microarray) products infringe the ‘228 patent, and that by selling these products Affymetrix is causing its customers to also infringe the patent. Neither Mulligan nor Housman would discuss the suit in detail, but they did explain to me that the products at issue are those designed for analyzing a certain type of genetic analysis, called SNP (pronounced “snip”) genotyping. “The issued patent, which is public record, describes the Affy SNP chip genotyping methodology,” says Housman. “It is what it is. Anyone who wants to compare the Affy SNP chip manual to the issued patent is welcome to do so. They are one and the same thing.”

There’s a history here. According to the complaint, in September of 2004, some six months after Housman’s patent was issued, Affymetrix filed its own U.S. patent application claiming the priority date of an earlier 1994 application. Then, in March 2005, Affymetrix added new claims that in effect “asserted the patentability of and ownership of the methods claimed in what is now the ‘228 patent.” An interference was initiated in April 2006 as the U.S. Patent and Trademark Office tried to sort out which group was first to develop the methods at issue, and on May 2, 2007—again according to the complaint–the PTO ruled “that the Housman group at M.I.T. was the first to invent the claimed methods and was therefore entitled to the patent.”

E8 and MIT allege that Affymetrix nevertheless kept on using the methods—and directed its customers to use them—in direct infringement of MIT’s patent. E8, meanwhile, now holds an exclusive license to the patent.

Housman and Mulligan are former MIT colleagues and longtime friends. Mulligan was not …Next Page »

Comments (1) | Reprints | Share:        

There goes another one: Cambridge, MA’s Archemix has withdrawn its planned IPO, citing unfavorable market conditions. The deal was to have been worth up to $63 million. VentureBeat Life Sciences has a good look at the quickly worsening environment for biotech offerings, in case you’re not bummed out enough already.

Comments | Reprints | Share:        

In a new filing with the SEC, Cambridge, MA’s Archemix set terms for its IPO of 4.5 million shares at $12 to $14 per share. The firm, which plans to trade on the NASDAQ Global Market under the symbol “ARCH,” is developing “aptamers,” or short strands of DNA or RNA, as treatments for a variety of ailments.

Comments | Reprints | Share: