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Gen-Probe HPV assay trial

This article was originally published in The Gray Sheet

Executive Summary

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)

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Gen-Probe HPV test

San Diego firm launches its Aptima molecular assay for human papillomavirus (HPV) in Europe May 28 upon gaining a CE mark. The assay, which detects 14 high-risk HPV types associated with cervical cancer, runs on Gen-Probe's Tigris and DTS instrument platforms. The firm began a 7,000-patient pivotal trial for U.S. approval of Aptima in March (1"The Gray Sheet" April 7, 2008, In Brief). Qiagen/Digene's Hybrid Capture 2 is the only FDA-approved molecular test for HPV

Qiagen Monopoly In HPV Test Market Won’t Last, Judge Says

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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