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Gen-Probe Targets 2011 for HPV Test in US; HIA Put on Backburner

NEW YORK (GenomeWeb News) – Gen-Probe is targeting a 2011 launch in the US for its molecular diagnostic assay for human papillomavirus, CFO Herm Rosenman told investors Wednesday afternoon at the UBS Global Life Sciences Conference.

The San Diego-based firm received the CE Mark and launched the Aptima HPV Assay in Europe in May. The test runs on its Tigris instrument system, which Rosenman said is the only fully automated molecular diagnostics instrument on the market.

Gen-Probe is currently conducting clinical studies on the assay in the US, and Rosenman said during a question-and-answer session that he believes 2011 will be a “good time to enter” the US market because it will be more mature at that point.

The only molecular test currently cleared for marketing in the US is offered by Qiagen. That firm’s CEO, Peer Schatz, noted Monday at the conference that the market for the molecular HPV test is highly underpenetrated.

While many firms have proceeded with plans to offer molecular tests for HPV in Europe, several have stayed away from the US market due to Qiagen’s intellectual property position. However, Rosenman said that IP is “not an issue” for Gen-Probe in looking to launch in the US market. In addition, he said he expects customers to adopt the Gen-Probe test once it is available because it is a “better test and better platform,” and it is fully automated.

Gen-Probe estimates that it will bring in 2008 revenue of around $472 million, with half of its sales coming from the blood screening market and the other half coming from infectious disease tests, with a focus on sexually transmitted diseases. The firm recently gained European approval for its Procleix Ultrio assay, which adds hepatitis B virus testing to its assay for HIV and hepatitis C.

Beyond those tests, Rosenman said that the firm sees future growth in molecular tests for oncology, genetic disorders, and hospital-acquired infections. In June, Gen-Probe and 3M disbanded their collaboration to develop molecular diagnostic tests for healthcare-associated infections, and the firm is now considering its options.  

Rosenman said that an HAI test is not “front of the burner” for Gen-Probe right now. “We’ll do something with that assay,” he said, but the firm is waiting to see how the market responds to the current molecular offerings from Cepheid and Becton Dickinson. He also said Gen-Probe has not decided whether it will proceed with developing the test itself or seek another partner.