CERVICAL CANCER TESTING

Cervical cancer is one of the most common cancers among women, with an estimated 11,000 cases of invasive cervical cancer expected to be diagnosed in the United States in 2009. Fortunately, if detected early, cervical cancer can be treated effectively and mortality rates have declined steadily over the past several decades due to early detection and prevention. Still, there are recognized limitations in today's screening processes and an estimated 4,070 deaths from cervical cancer are expected in 2009.

Each year in the United States approximately 50-60 million Pap tests are performed as the primary screening test for the detection of cervical cancer. Approximately 10% of women have abnormal Pap test results each year and require follow-up testing. Of these 5 million women, only 10-15,000 will develop cervical cancer. The great disparity between the abnormal Pap test results and the disease rate is primarily due to the lack of accuracy of existing tests.

The widespread introduction of Human Papillomavirus (HPV) testing in recent years has provided clinicians with an additional patient management tool. HPV is among the most common sexually transmitted infections that afflict an estimated 8 out of 10 women by the age of 50. HPV is a necessary, but not sufficient condition, for the development of almost all types of invasive cervical cancer. Whereas the utility of HPV as a "rule-out" test is broadly accepted, its clinical utility is severely limited in patients testing positive, as the vast majority of HPV infections spontaneously regress without intervention.

Studies have shown cervical carcinogenesis is caused by the affect of persistent HPV infection leading to the expression of critical viral proteins that disrupt the regulation of the cell cycle. These changes can result in chromosomal DNA damage, the earliest event in cervical carcinogenesis. This DNA damage is irreversible, and unlike other cytologic abnormalities, it will not regress and without the appropriate intervention will lead to more severe dysplasia and precancerous conditions.

Now available, using science developed at The National Cancer Institute, is a molecular diagnostic test that looks for chromosomal damage to the cervical cell DNA. The Cervical DNA Dtex® test can be used in conjunction with standard screening practices to help identify those women with DNA damage to their cervical cells that will likely progress to cervical cancer.