New generation screening test for cervical cancer
Higher individual safety for younger women
More accurate patient management
Reducing current cervical screening failure rate
Low cost and high capacity screening
Cervical cancer is the most common cancer in women under 35 years of age. The main cause of cervical cancer is the human papilloma virus (HPV). Most women are infected with HPV during their lifetime and as many as 10-30 % of a female population below 35 years of age may be infected*) .
Highest incidence rates in women below 40 years of age
In countries having a cervical cancer screening program women below 40 years of age have the highest cervical cancer incidence rates as illustrated by the graph below (UK data). The actual number of cervical cancer cases is about the same for the three age groups 25-29, 30-34, and 35-39. Cytology has successfully reduced the incidence of cervical cancer among women above 40 years of age (see graph below). However, in women below 40 years of age, cytology is failing to prevent cervical cancer to the same degree.
To be able to prevent cervical cancer among younger women implementation of new technology is needed.
In addition about 50 % of women treated for severe pre-stages of cervical cancer are below 30-35 years of age. This indicates that a significant number of young women are treated unnecessary in relation to lack of incidence reduction among these women.
*) This percentage may vary between countries and between different populations within a country.
PreTect SEE - specific focus on the highest known risk factors
PreTect SEE is focusing on the HPV types with the highest risk of cervical cancer among younger women (HPV 16, 18 and 45). To further increase the specificity, only active oncogene expression from the E6/E7 oncogenes are measured.
Published research show that about 90 % of the cervical cancer cases in younger women are caused by only the 3 HPV types 16, 18, and 45 (e.g. Munoz N, Int. J. Cancer: 111, 278–285 (2004)). The Nobel prize winner Harald zur Hausen has shown that the oncogenic proteins E6/E7 are a necessary factor in development of cervical cancer (zur Hausen H. Papillomaviruses and cancer: from basic studies to clinical application. Nat Rev Cancer. 2002 May;2(5):342-50. Review).
PreTect SEE as an adjunct test to cytology
Test results from more than 5 000 women participating in the Norwegian national screening program show that PreTect SEE has a significantly higher specificity than cytology. In addition only about 2-3 % of women having a NILM cytology result is positive with PreTect SEE. By cytology re-screening of the PreTect SEE positives, most are found to have visible cell abnormalities, which were initially overlooked.
The PPV for CIN2+ using PreTect SEE has been shown to be above 10 % on NILM cytology samples. According to common practice within the field of cervical pathology, such high risk populations may be immediately referred to colposcopy/biopsy (see e.g. Castle, P. E., Sideri, M., Jeronimo, J., Solomon, D., & Schiffman, M. (2007). Risk assessment to guide the prevention of cervical cancer. American Journal of Obstetrics and Gynecology, 197(4), 356.e1–356.e6).
PreTect SEE may increase the number of CIN2+ found among younger women by 20 % if used as an adjunct test to cytology. These women are missed by cytology (initially having a NILM cytology diagnosis), but have a CIN2+ and in addition active oncogenic expression caused by the most carcinogenic HPV types. PreTect SEE enables finding and treating these women instead of referring them back to the next cervical cancer screening round in e.g. 3 or 5 years.
Please observe that PreTect SEE is not intended to prevent women from follow-up based on abnormal cytology results. Women having an abnormal cytology result and a negative PreTect SEE result should be referred to appropriate follow-up dependent on the cytology result.
Please contact PreTect for more information about PreTect SEE.