Piper Jaffray Healthcare Conference In Brief

Qiagen: Firm will pursue full pre-market approval for Ensemble, "the first ever continuous loading molecular diagnostic instrument," Qiagen Senior VP of R&D Jim Godsey announced Dec. 2 at the Piper Jaffray Healthcare Conference in New York City. Ensemble is compatible with Hybrid Capture human papilloma virus screening technology. According to Qiagen, the Ensemble JC2000 instrument can run 2,000 specimens per one eight-hour cycle and 5,000 specimens in two back-to-back shifts. The company also is developing a model for low-to-medium throughputs. Clinical trials, which likely will include 30,000-40,000 specimens, will begin in the first half of 2009, Godsey says. Qiagen gained Hybrid Capture 2, the only FDA-approved molecular HPV screening test, when it acquired Digene in 2007. Qiagen dominates the U.S. HPV market now, but will soon face competition from Hologic/Third Wave's Cervista, which is pending PMA approval, and down the line, from Gen-Probe (Aptima) and diversified drug giant Roche (Amplicor)