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news.Gen-Probe has launched in Europe its Aptima HPV assay, a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus, which causes cervical cancer.
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The Aptima HPV assay is an amplified nucleic acid test that detects 14 high-risk human papillomavirus (HPV) types that are associated with cervical cancer. More specifically, the assay is said to detect two messenger RNAs, E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer.
The Aptima HPV assay is designed to run on Gen-Probe’s fully automated, high throughput Tigris instrument system and on the company’s semi-automated DTS instrument platform, and is expected to run on the company’s future, fully automated instrument for low- to mid-volume laboratories.
The Aptima HPV assay has been CE marked and is currently available for sale in 13 EU countries. The Aptima HPV assay is in clinical studies in the US, and is not approved for marketing by the FDA.