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Transgenomic Plans Diagnostics Debut Without Opening Its Wallet

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

As CEO Collin D'Silva puts it: "We are optimistic about emerging opportunities to leverage our Wave technology in several higher-value markets, including molecular diagnostics and oncology-related theranostics."

Translation: He wants to help make the Wave machine a staple in US-based molecular-diagnostic labs, and in the process 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.

In an interview with GenomeWeb, SNPtech Reporter's sister publication, Rob Pogulis, Transgenomic's director of strategic planning, said the firm is "really in the early-going here to just enhance targeting of institutions, entities, and individuals involved in clinical-diagnostic testing.

"So that's the first step at this point," he said. "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 logistical stretch--clinics in the UK and France already use the technology to help diagnose colon cancer and cystic fibrosis. The logistics 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-lab settings. 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 look for the company to spend any additional cash to get there. In fact, last November, Pogulis foreshadowed Transgenomic's staff cuts when he stressed that the firm's downstream focus does 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

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