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Cervical cancer assay

This article was originally published in The Gray Sheet

Executive Summary

German diagnostics firm mtm laboratories launches its CE-marked Cervatec assay in Europe for detecting cervical cell protein biomarkers. Used with conventional Pap testing, Cervatec is more than twice as sensitive as Pap tests alone in cervical cancer screening, the firm said Feb. 5. Unlike available molecular human papillomavirus (HPV) tests such as Qiagen/Digene's Hybrid Capture, Cervatec indicates the presence of the disease, not just an elevated risk, mtm CEO Peter Pack said. The firm could not disclose whether it would seek FDA approval for the test

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