bioMérieux Brings a New Concept in Molecular Diagnostic Testing for the Prevention of Cervical Cancer
bioMérieux, a world leader in the field of in vitro diagnostics, has launched
NucliSENS EasyQ® HPV, a molecular diagnostic test for the detection of human papillomavirus used in the prevention of cervical cancer.
Cervical cancer is the leading cause of cancer-related deaths among women in developing countries and the second most common cancer among women worldwide, causing over 250,000 deaths annually.1 Human papillomavirus, or HPV, is the cause of 99.7% of cervical cancer cases.2 Research into HPV-induced cancer has demonstrated that HPV genotypes 16 and 18 cause approximately 70% of cervical cancers worldwide.3
In most cases, HPV infections are transient. However, in around 20% of women, HPV infection may persist leading to the development of cervical lesions. 1 to 10% of these lesions can develop into cervical cancer. It is therefore important to clearly identify those women at increased risk of developing cervical cancer at an early stage.
Molecular diagnostic techniques for the detection of HPV are used to screen women with suspected pre-cancerous lesions. Combined with cytology findings (Pap smears), they help determine which women with abnormal (ASCUS*) cervical cytology results should be referred for immediate colposcopy, biopsy and treatment.4
Most current HPV molecular tests are DNA-based (detecting the HPV genome), and show the presence of the virus in the patient’s cervical cells. However, a positive result for this kind of test only indicates HPV infection, which can be either transient or persistent. Such tests do not make it possible to assess the virus’ oncogenic activity (ability to cause cancer).
It is now known that persistent expression of viral oncoproteins E6 and E7 occurs following the integration of the viral genome into the host genome in cervical cells. This abnormal expression affects the cell cycle, increasing cell proliferation and initiating the cervical cancer process. The E6/E7 oncoproteins are therefore early cancer markers.5
Several publications have demonstrated that the detection of E6/E7 expression (mRNA) is closely correlated to the presence of high-grade precancerous lesions in women with ASCUS/LSIL** cytology. This type of test is more specific and has a higher medical value compared to DNA-based methods.6,7,8 This translates into better identification of those women requiring immediate colposcopies, and a reduced number of unnecessary invasive examinations (colposcopies, biopsies).9
The NucliSENS EasyQ® HPV test is based on an innovative concept, enabling direct detection of the expression of oncogenic risk factors, E6 and E7 from the 5 most prevalent HPV types in cervical cancer worldwide (HPV 16, 18, 31, 33 and 45). NucliSENS EasyQ HPV is thus a high medical value test for physicians that can significantly contribute to improved patient management.
There is growing awareness of the added clinical value of E6/E7 mRNA testing, resulting in their recent inclusion in the Danish National Guidelines for Cervical Cancer Screening. 10
