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Molecular Diagnostics a Major Focus at UBS Conference

NEW YORK (GenomeWeb News) – After just day one day at the UBS Global Life Sciences Conference in New York it is clear that life science tools firms and investors alike remain very interested in the fast-growing molecular diagnostic market.
With a variety of companies pegging the global molecular diagnostics market currently at around $3 billion, conference speakers were eager to show off their current offerings and future plans for the market.
Speaking on Monday, Qiagen CEO Peer Schatz focused a large chunk of his presentation and question-and-answer session on the firm’s human papillomavirus test franchise, which the firm gained through its acquisition last year of Digene. With around $435 million in molecular diagnostics revenue expected in 2008, Schatz noted that roughly 50 percent of that revenue would come from the firm’s HPV test.
Qiagen has a variety of follow-on tests for HPV expected to launch over the coming year or two, including a genotyping test expected in 2009.
As he has mentioned at previous events, Schatz said that the HPV test market is highly underpenetrated, particularly in the US. As part of its efforts to grow the market, Qiagen has increased its sales staff that focuses on sales to physicians, rather than labs, from 70 employees to 120. He also said Qiagen is looking beyond just the early adopters to increase sales.
Beyond HPV, Schatz said the firm’s QIAplex multiplexing molecular diagnostics technology is gaining significant interest among potential partners. Just yesterday, UK-based Osmetech said it will adapt a QIAplex respiratory viral test for use on its eSensor XT-8 molecular diagnostics system.
Also on Monday, Nanosphere President and CEO William Moffitt cited a potentially large growth opportunity for a cardiac test that the firm has in development. The firm currently sells a warfarin sensitivity assay that is driving its revenues, while a cystic fibrosis assay has been delayed for filing with the US Food and Drug Administration. Moffitt said Nanosphere hopes to file that test during the fourth quarter of this year and it expects to receive an expedited review, based on conversations with FDA.
But the big market potential for Nanosphere right now is a molecular test for the cardiac marker Troponin I, which it hopes to get on the market by the middle of next year, said Moffitt. He estimated the market for Troponin I tests at $700 million. In addition, he said that Nanosphere’s test is sensitive enough to detect unstable angina, a claim that no current test can make.
Celera CEO Kathy Ordoñez also talked about the market potential for her firm beyond the cardiovascular tests it offers through its Berkeley HeartLab unit. She said Celera plans to license oncology markers to broaden its test menu. In addition, she said the firm, which holds over $300 million in cash on its balance sheet, is looking for merger and acquisition opportunities and would consider another lab acquisition similar to BHL, though no such deal is in the works.
She also said that Celera intends to eventually pursue direct-to-consumer diagnostics as well, though no timeframe was provided for such efforts.
This morning, amid the discussion of its burgeoning sequencing business, an Illumina official also briefly discussed the company’s molecular diagnostics plans. Senior VP and CFO Christian Henry told investors that the firm is just starting its “execution mode” for molecular diagnostics.
He said that Illumina would likely use a combination of its technologies, specifically its Genome Analyzer II sequencer and BeadXpress array platforms, to address the molecular diagnostic market. Henry said the company would focus on highly multiplexed samples and get into disease areas where “complexity matters.”
In gearing up for its MDx push, Illumina hired a former Roche executive, Greg Heath, to spearhead its diagnostics efforts. In addition, Henry said that the firm expects to receive 510(k) clearance from FDA for its BeadXpress platform next year. 

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