Gen-Probe Launches in Europe CE-Marked APTIMA® HPV Assay for Detection of Human Papillomavirus
Product News May 29, 2008
Gen-Probe Incorporated has that the Company has launched in Europe its APTIMA® HPV Assay, a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus (HPV), which causes cervical cancer. The APTIMA HPV Assay has been CE marked and is currently available for sale in 13 European Union countries.
"The CE marking and launch of our APTIMA HPV Assay in Europe reflect Gen-Probe's commitment to the development of novel, more accurate molecular diagnostic tests to detect life-threatening infectious diseases such as cervical cancer," said Carl Hull, Gen-Probe's president and chief operating officer.
"In addition, we are hopeful that, over time, our HPV test will become an important long-term financial growth driver on both our current and future automated instrument platforms."
The APTIMA HPV Assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer.
Gen-Probe believes that targeting these mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women, who are infected, but HPV infections are common and many resolve without causing 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 is being manufactured by Gen-Probe's subsidiary, Molecular Light Technology, in Cardiff, Wales.
The APTIMA HPV Assay is in clinical studies in the United States, and is not approved for marketing by the U.S. Food and Drug Administration.