Multi-Center Study to Evaluate Nucleic Acid Test for HPV

More specifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, which are made in higher amounts when HPV infections progress toward cervical cancer.

The Aptima HPV assay is designed to run on Gen-Probe's (San Diego, CA, USA) fully automated, high-throughput Tigris instrument system, and on the company's current and future medium-throughput instrument platforms. 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 clinical study includes two arms--one arm enrolls women whose Pap results are classified as atypical squamous cells of undetermined significance (ASC-US), meaning they are neither normal nor clearly indicative of changes associated with progression to cervical cancer. In these cases, HPV testing can help determine appropriate medical management. The other arm enrolls women over age 30 whose Pap results are normal. This arm will assess the ability of the Aptima HPV test to identify women who are at greater risk for cervical cancer.

Although Pap testing succeeded in reducing mortality from cervical cancer in the United States, it has 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 approximately two million of the 50 million Pap tests performed annually in the United States have equivocal results, which are known as atypical squamous cells of undetermined significance (ASCUS). These women are often subjected to additional invasive tests, including biopsies, most of which prove negative.

"Starting this highly complex, multi-center study was an important goal for Gen-Probe in early 2008,” said Carl Hull, the company's president and chief operating officer. "Enrolling our first patient last week is a testament to the hard work of our integrated product development team. We expect that their extensive efforts to date will ultimately result in the introduction of a highly accurate Aptima HPV assay that improves the detection and treatment of cervical cancer.”


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