HPV OncoTect® E6, E7 mRNA
HR HPV is a necessary cause of cervical cancer. HR HPV screening for cervical cancer ensures adequate sensitivity and a high Negative Predictive value. However since not all HR HPV infections will lead to cervical cancer, the Positive Predictive Value for HR HPV screening is low.
- 92% of women will spontaneously clear the high risk HPV virus within the first two years
- Only 3-10% of women with high risk HPV will develop precursor cancer lesions
- More specific tests are needed
- Many women are undergoing unnecessary procedures which add cost and risk to screening programs that utilize HR HPV screening
To improve on specificity, assays need to target genes within the HPV virus that are responsible for the cellular transformation process associated with the development of cervical cancer.
- The HPV virus is made up of nine different genes.
- Many of the high risk HPV assays are based on the detection of the L1 DNA gene.
- Genes E6 and E7 produce mRNA which if overexpressed can lead to cellular transformation, uncontrolled cell division and precursor cancer lesions of the cervix.
- Assays based on E6/E7 mRNA are more predictive for identifying precursors of cervical cancer than assays based on detection of the L1 DNA gene