Qiagen Monopoly In HPV Test Market Won’t Last, Judge Says
This article was originally published in The Gray Sheet
Executive Summary
A U.S. district court turned down Third Wave Technologies' claims that Qiagen engages in anti-competitive behavior in the cervical cancer screening space, but the ruling suggests the direction of the market will be in Third Wave's favor
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Gen-Probe HPV assay trial
San Diego diagnostics firm Gen-Probe begins a 7,000-patient U.S. pivotal trial in late March of its Aptima molecular assay to detect human papillomavirus (HPV). The amplified nucleic acid test detects 14 high-risk HPV types associated with cervical cancer. One arm of the multi-center clinical study will enroll women whose Pap results are classified as atypical squamous cells of undetermined significance (meaning they are neither normal nor clearly indicative of progression to cervical cancer), and the other arm will enroll women over age 30 with normal Pap results. Qiagen/Digene (Hybrid Capture 2) offers the only FDA-approved molecular assay for HPV, but a number of competitors are seeking market entry (1"The Gray Sheet" Jan. 21, 2008, p. 22)