If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Digene HPV Test For Cervical Cancer More Specific Than Pap Smear GAITHERSBURG, MD -- March 17, 2000 -- Digene Corporation announced that preliminary results of the National Cancer Institute's (NCI) ALTS (Ascus/Lsil Triage Study, and Alternatives in Women's Health Care) trial were presented yesterday at the American Society for Colposcopy and Cervical Pathology's Biennial Meeting in Orlando, Florida. The preliminary results indicated that the Digene HPV Test was 96 percent sensitive in detecting cervical disease in women with ASCUS Pap smear diagnoses while the expert Pap smear used in the trial was just 85 percent sensitive. In addition, the HPV Test was slightly more specific than the Pap smear. Evan Jones, Chairman and CEO, Digene Corporation commented, "Based on these conclusive results, it is clear that HPV testing should become the method of choice for patient management of women with ASCUS Pap smear results. In the past, doctors have struggled to tell the difference between women whose borderline abnormalities will go away without treatment and those that will progress to a precancerous condition or cancer. We now have data from the largest study in the field that Digene's HPV Test can determine definitively those women who are at risk for the development of cervical cancer. The ALTS results could affect positively the management of the approximately 3 million women each year who have borderline Pap smear results." The ALTS trial was designed to answer one of the most controversial questions in women's cancer and infectious diseases: What should women and their physicians do about the mild abnormalities that often show up on Pap tests. The trial was designed to determine whether HPV testing can help predict which women are at higher risk of high grade cervical disease (HSIL). Certain carcinogenic types of human papillomavirus (HPV) have been determined to be the cause of cervical cancer. Although the borderline (ASCUS, or equivocal) category contains the largest percentage of cases of underlying high-grade cervical disease, most women with borderline Pap smears do not have underlying cervical disease and are therefore not at risk for the development of cervical cancer. The ALTS trial, organized and funded by the NCI, the U.S. government's principal agency for cancer research, is a $20 million 5 year trial enrolling approximately 7,200 women with mild Pap smear abnormalities, and has been conducted at four major medical centers: the University of Alabama in Birmingham, Alabama; the University of Oklahoma in Oklahoma City, Oklahoma; Magee-Women's Hospital in Pittsburg, Pennsylvania; and the University of Washington in Seattle, Washington. Approximately 15,000 American women are diagnosed with cervical cancer each year and about 5,000 die of the disease. In areas of the world where cervical cancer screening is not available, cervical cancer is the leading cause of cancer deaths in women. Mr. Jones concluded: "We are extremely pleased that the results of the ALTS trial confirm the findings of earlier studies in the field. These findings should help accelerate the widespread adoption of HPV testing for women with the ASCUS Pap smear diagnosis. The study is the largest of its kind and was designed to be the definitive study to help determine the appropriate patient management for women with ASCUS Pap smears." Digene Corporation, based in Gaithersburg, Maryland, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases. The Company has developed and is commercializing its patented Hybrid Capture(R) Gene Analysis System and tests in three areas: women's cancers and infectious diseases, blood viruses, and in the emerging field of pharmacogenomics. Digene's primary focus is in women's cancers and infectious diseases where the Company's lead product is the only FDA approved test for human papillomavirus, or HPV, which is the cause of greater than 99 percent of cervical cancer cases. The Digene HPV Test is used in the U.S. as an adjunct to the Pap smear for cervical cancer screening and is being marketed in selected countries as a primary cervical cancer screen either in conjunction with or separate from the Pap smear. The Company's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, and tests for blood viruses. Related links: Digene Corporation.
|
