Page 8
Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer. Most acute infections caused by HPV are sel-limiting [1, 4-7]. It is the persistent HPV infection that may act as a tumor promoter in cancer induction [8-11]. Identifying and typing HPV is an important tool for following patients with persistent HPV infection. Repeated sequential transient HPV infections, even when caused by « high-risk » HPVs, are characteristically not associated with high risk of developping squamous intraepithelial lesions, a precursor of cervical cancer.

A woman found to be positive for the same strain (genotype) of HPV on repeated testing is highly likely suffering from a persistent HPV infection and is considered to be at high risk of developing precancerous intraepithelial lesions in the cervix. It is the persistent infection, not the virus, that determines the cancer risk.

The FDA has accepted the above interpretation of current medical science, as reflected in its March 31, 2003 announcement on aproval of the digene HC2 High-Risk HPV DNA Test while making the following public statements on record [I].

« The FDA today approved expanded use of a laboratory test detect the presence in women of human papilomavirus (HPV), one of the most common sexualily transmitted infections. »

« The HPV DNA test does not test for cancer, but for HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women. »

« Most women who become infected with HPV are able to eradicate the virus and suffer no apparent long-term consequences to their health. But a few women develop a persistent infection that can eventually lead to pre-cancerous changes in the cervix. »

« ...most infections are short-lived and not associated with cervical cancer. »