>>Gen-Probe Launches in Europe CE-Marked APTIMA(R) HPV Assay for Detection of Human Papillomavirus
Wednesday May 28, 4:01 pm ET
SAN DIEGO, May 28 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO - News) announced today 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.
"By targeting two HPV genes that are associated with progression to cervical cancer, the APTIMA HPV assay may increase the specificity of cancer detection," said Jack Cuzick, professor of epidemiology at the Cancer Research UK Centre for Epidemiology, Mathematics and Statistics in London. Prof. Cuzick is leading the 953-woman "Predictors" study, a head-to-head comparison of various HPV assays. "Increased specificity -- meaning fewer false positive results -- is important so women are not subjected to the anxiety and expense of unnecessary medical procedures," he said. Data from the Predictors study were presented by Prof. Cuzick and other independent European researchers at the 24th International Papillomavirus Conference and Clinical Workshop in November of 2007.
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.
About HPV and Cervical Cancer
HPV is a group of viruses with more than 100 types, 14 of which have been categorized as high risk for the development of cervical cancer. While most women will be infected with HPV at some point in their lives, the majority of these infections are transient and resolve without any clinical symptoms or consequences. However, a small number of HPV infections progress and result in disease ranging from genital warts to cervical cancer. Since most HPV infections do not result in cancer, there is a need for a more specific test to identify women at greater risk of developing the disease.
The most common test used for cervical cancer screening is the Pap test. Although the Pap test has helped reduce mortality from cervical cancer in many countries, it does have limitations. One such limitation is poor sensitivity of individual Pap smears, which means the test misses cancers or precancerous changes. As a result, regular and repeated Pap testing is required to effectively detect a high proportion of cervical cancers. Another limitation is that a small portion of women have equivocal Pap results, which are known as ASC-US. These women are often subjected to additional invasive tests, including biopsies, most of which prove negative.<<
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So here again we have another 14 mutation assay. Further, you have to have one of those two GPRO platforms to run it, so penetration may be limited. I don't know how widespread those systems are -- the GenProbe is a pretty successful company. I was also interested to learn of the "Predictor" trial, though the abstract from the referenced conference does not seem to be available. This, a Digene HC2 versus the Roche Amplicor (no real winner) study, appears to be a precursor:
pubmedcentral.nih.gov
Neither stock appears to be moving much on the news.
Cheers, Tuck |
