Roche Amplicor HPV Test To Battle With Digene: A David & Goliath Scenario?
This article was originally published in The Gray Sheet
Executive Summary
Roche Diagnostics' plan to obtain a CE mark by the second quarter for its Amplicor human papillomavirus PCR-based test and complete U.S. trials by Q2 2005 has Digene scurrying to maintain its DNAwithPap first-to-market advantage
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Roche Amplicor HPV test
Roche study comparing Amplicor with Digene's Hybrid Capture 2 test suggests Amplicor may be more sensitive, according to Jane Gibson, PhD, molecular genetics director at the AmeriPath Center for Advanced Diagnostics in Orlando. Presented at the 21st International Papillomavirus Conference in Mexico City, the results reveal an HPV-positive rate of 15.1% with Amplicor and 9.3% with the HC2 test. The presence of high-risk HPV was confirmed in 33% of Amplicor positive/HC2 negative specimens. Roche plans to complete U.S. clinical trials of the polymerase-chain reaction test by Q2 2005 (1"The Gray Sheet" Feb. 9, 2004, p. 14)...