In-vitro Diagnostics

High-Risk HPV Detection

• High-Risk HPV can be found in virtually all cases of cervical cancer.
• High-Risk HPV comprise: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 with the potential to add others recently recognized
• HGS has developed a novel assay for the detection of High-Risk HPV in clinical samples using bisulphite genomic simplification.

HGS’ High Risk HPV Detection Kit:

High-risk HPV detection as a Demonstrator product for HGS’ Simplification Technology

As a result of the successful development and performance of the “ultra-preserving” Bisulphite modification method and resultant simplification claim for diagnostic purposes, HGS focused its efforts on developing vital proof of principle and clinical utility (medical usefulness). To this end, the company identified several diagnostic markets that were of sufficient size and growth, and that demonstrated a clear clinical need.

Of the many considered, Human Papilloma Virus (HPV) represented a market with large potential volume, significant annual growth, high clinical usefulness for HGS’ Molecular-based testing and so far, still relatively unsaturated with competitive products and services. The disease offers both a compelling medical story and significant business opportunity for existing and new entrants to this market.

HGS’ Early Stage HPV Detection – Raising The Alarm Early, Simplified.

HGS’ molecular assay offers a remarkable array of benefits for any commercial or hospital Laboratory seeking to perform early stage Molecular HR-HPV testing.

• Ultra-sensitive, highly specific, reliable detection of the 13 High-risk HPV subtypes
• Practical and flexible testing conditions, functioning well from the use of several popular cell-storage media, post-PAP, including samples containing blood and tissue contaminants.
• HGS’ patented simplification process permitting the use of minimal DNA probes, whilst also reducing the cross-reactivity that can plague other methods and significantly reducing the number of false positive results.
• A faster, less lab-laborious process compared to other testing methods on the market.