Clinical Applications

3base™ Explained

Patents / IP

Clinical Applications

Clinical Applications

Proof of Principle for 3base™: High-Risk Human Papilloma Virus Detection

Synopsis
Human Papilloma Virus (HPV) represents a market with large potential volume, significant annual growth, high clinical usefulness for Human Genetic Signatures' molecular-based testing and so far, still relatively unsaturated with competitive products and services. It also represented a technical challenge to fully test the method. High-risk HPV is a direct precursor for Cervical Cancer in women.

Potential
In 2003 in the US, amendments were made to the Pap testing protocol to include HPV test as an adjunct with Pap testing for women aged 30 and over. This amendment was based on studies that showed 20% of women aged 30 and older that tested positive for HR-HPV were suffering from high-grade cervical disease. Cytology reporting from Pap testing has been a reliable mainstay for the detection and treatment of cervical cell abnormalities. But recent studies have indicated that significant improvements in early HR-HPV detection and subsequent viral persistence can greatly assist medical practitioners in earlier intervention and cancer prevention.

Technical Description
A novel assay (based on the product MethylEasy™, manufactured by Human Genetic Signatures), has been developed to improve the specificity to detect high risk HPV DNA. This product is currently the foundation for presenting proof of principle of our Simplification technology for the purposes of licensing business to 3rd party Diagnostic Manufacturers.

Clinical Validation
We have completed a clinical trial involving 835 patient samples for the detection of high-risk human papilloma virus utilising its completed HR-HPV in-vitro diagnostics assay. This trial compared the Human Genetic Signatures kit with the current FDA approved product for HPV detection, the Digene Hybrid Capture II (HC2) assay. The results demonstrated that our product was superior to the HC2 kit, by displaying less false-positive detections of HPV in a sample (statistically significant: p>0.001).

This trial has resulted in a publication in Journal Clinical Virology:

• Comparison of a novel HPV test with the Hybrid Capture II (hcII) and a reference PCR method shows high specificity and positive predictive value for 13 high-risk human papillomavirus infections.

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