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Transgenomic, Rubicon Genomics

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Transgenomic Plans Diagnostics Debut Without Opening Its Wallet

Despite having laid off a quarter of its staff, including its CFO, earlier this month, Transgenomic said it is still driving to make its Wave platform a player in the diagnostics arena.

However, don’t expect the company to spend additional cash to get itself there.

“We are optimistic about emerging opportunities to leverage our Wave technology in several higher-value markets, including molecular diagnostics and oncology-related theranostics,” said CEO Collin D’Silva.

D’Silva wants the Wave machine to be a staple in US- based molecular-diagnostic labs and to nab a piece of a market some say may reach $3.7 billion by 2006. The challenge for Transgenomic is to distinguish itself from the likes of Nanogen and Third Wave, which have similar designs.

Rob Pogulis, Transgenomic’s director of strategic planning, stressed that the firm is “really in the early-going here to just enhance targeting of institutions, entities, and individuals who are involved in clinical-diagnostic testing.

“So that’s the first step at this point,” he told SNPtech Reporter. “We’re not necessarily fleshing out lots of details, but we certainly want to make a concerted effort to advance the Wave technology into the [US-based] clinical-diagnostics setting.”

To be sure, moving the Wave platform from the bench to the clinic would not be a great logistical stretch — clinics in the UK and France already use the technology to help diagnose colon cancer and cystic fibrosis. The logistics do get tricky when US regulatory requirements come into play.

However, because the Wave instrument does not have 510K marketing clearance from the FDA, its use in the United States is limited to CLIA-certified labs. And because molecular diagnostics are regularly performed in CLIA labs, Transgenomic can first “look for opportunities with those sorts of users,” Pogulis explained.

But don’t hold your breath for the company to crack open its wallet to pay for its entrée into CLIA labs. In fact, last November, Pogulis foreshadowed Transgenomic’s staff cuts when he stressed that the firm’s downstream focus would not necessarily portend an increase in R&D spending or in sales and marketing efforts. “There’s really not a whole lot to develop other than optimizing the specific PCR amplicons for the genes of interest,” he said.

—KL


Rubicon Plans to Launch Two New Tools in March

Rubicon Genomics expects to launch by the end of March two new tools based on its Omniplex genome-amplification technology that can be used for inexpensive SNP-scoring services, a company official told SNP tech Reporter.

The first product, designed for targeted-genome amplification, would amplify only specific areas of the genome rather than the entire length of DNA. The second, for molecular haplotyping, foregoes statistical inferences in favor of the “mother-father-child approach,” said CEO Fred Beyerlein.

Each tool is an offshoot of the genome-amplification platform, which is itself based on Rubicon’s OmniPlex technology. According to Beyerlein, the technology relies on an enzymatic reaction called nick translation that reformats chromosomes into new molecules called plexisomes that are able to be more easily amplified and manipulated.

According to Rubicon, the nick translation process breaks down DNA into discrete strands of equal length. In this format, DNA can be easily searched for multiple SNPs, and the technology could allow the company to offer SNP-scoring services for less than $.01 per polymorphism, he said.

The products are currently undergoing proof-of-concept trials with “a combination of large platform companies, large pharma, and the biopharma companies, and at least two of the major genome centers” for whom the tools represent “a natural extension of what they’re doing now.”

Beyerlein said Rubicon does not intend to hire additional staff to market or sell the products. “We don’t see a particular need for it,” he explained. “It’s a natural extension of the relationships we’ve built up with current clients.” Beyerlein would not disclose who those clients are.

He said Ann Arbor, Mich.-based Rubicon is “preparing” for a Series C round of private-equity financing, but stressed he expects to “support ourselves until better times come around, on our own revenues and conservation of cash.”

Rubicon, which currently employs 60 staffers, closed a Series B round in October worth $3.5 million. Investors in that round included ARCH Development Partners, Duchossois TECnology Partners, Sloan Ventures, and undisclosed individual investors.

—KL

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