New diagnostics necessary to eradicate genital herpes

Important results from the project

We have shown in preliminary studies that our antibody assay can better identify those individuals who are HSV-2 infected compared to the globally most widely used commercial assays. We will develop a prototype assay by producing antigen in larger quantities, optimizing the assay to the appropriate format followed by validation against established commercial assays. We will also contact companies with an interest in the diagnosis of HSV-2 infection, develop our PCT application and further develop a strategy to strengthen our IP protection with a focus on HSV-2 infection.

Expected long term effects

We have developed a prototype assay to detect HSV-2-specific antibodies using ELISA technology Our assay shows higher sensitivity and specificity compared to the most commonly used commercial assays. We have considered an in-house commercial production and contacted various diagnostic companies with aim to sell the assay. Our specific requirements in the patent application of the gG-2 molecule have been approved in Europe. The US patent authority is now examining our first submission. We conclude that our objectives have been successfully implemented.

Approach and implementation

The project first involved technical verification of our assay, including the choice of method and components to define the final product. The product was then carefully tested against other relevant commercial products. Subsequently, a number of commercial companies were contacted both in the production of antigen and in the field of diagnostics. The patent application has been developed together with consultants in both Sweden and England to strengthen the protection of the gG-2 molecule for diagnostics.