Research & Development

Genetic tests – HPVCombing test

Molecular Combing has the ability to detect Human Papillomavirus (HPV) DNA integration into human cervical cell chromosomes, which are determinants for assessing cervical cancer risk.

Product Status

We are currently developing a new generation of test to detect DNA integration of HPV.

Disease Background

Persistent infection with high-risk types of HPV induces dysplastic lesions, i.e., the earliest stage in cancer progression, characterized by increased cell proliferation. Some of these lesions will eventually progress to invasive cancers. Major factors that determine cancer progression are:

• High risk associated with certain HPV sub-types (especially types 16 and 18)
• Integration of HPV DNA into the human genome
• Increase in genomic instability following integration, and genetic changes in the cervix

Limitations of Current Methods

To date, the focus for detecting HPV has been on identifying the viruses’ DNA. However, the majority of HPV infections are transient or non-transforming, creating a high number of false positives and a low clinical specificity for HPV DNA testing methods.

In contrast, detecting HPV integration into the human genome, which is regarded as an important transforming step for carcinoma development, may be better suited to diagnose development of severe dysplasias. One commercial test looks at the ratio of E6 to E7 mRNA as a biomarker for indirect viral integration and transforming HPV infections.