European Patent Granted for HIV Prevention Point-of-Care Test - “GIFT”.

A European Patent was recently granted to UCT by the European Patent Office (EPO) for a Method for Diagnosing an Inflammatory Condition in the Female Genital Tract invented by Dr Lindi Masson and A/Prof Jo-Ann Passmore. The European patent was further validated in the UK, Germany, and France. This is major milestone for the team involved and indicates that a high level of innovation has been applied towards solving a real-world problem.

Women in resource-constrained environments throughout Africa are at high risk of becoming infected with HIV and experiencing adverse pregnancy outcomes because of vaginal infections or bacterial vaginosis (BV). This is largely due to a lack of accurate and affordable diagnostic and treatment options for vaginal inflammation caused by sexually transmitted infections (STIs) and BV.

In many cases, women who have an STI or BV show no symptoms of infection and, therefore, do not receive the necessary treatment. This is especially true in resource-limited settings where syndromic management is implemented as a more affordable but less accurate screening tool than laboratory-based STI screenings.

In 2010, Dr Masson and A/Prof Passmore, then both researchers at UCT’s Division of Medical Virology, discovered that young South African women were more likely to have a certain type of vaginal inflammation, which could provide ideal conditions for HIV infection. This finding led to the invention of the Genital InFlammation Test (GIFT), a lateral flow device that can detect both asymptomatic as well as symptomatic inflammatory vaginal infections via vaginal cytokine biomarkers. The simple, low cost test can be done quickly and easily at the point of primary care or as part of home care.

The team has validated the biomarkers in multiple cohorts of women and completed the proof-of-principle, feasibility, and optimisation phases of the development of the first prototype device. The next phase of the project involves validating antibodies for the biomarkers, ensuring the quality of each antibody batch, and reducing the cost of the final test.

Philip Hoekstra, UCT’s Intellectual Property Manager, and Tshepi Khahlu, Senior IP Officer, is assisting the inventors with managing the intellectual property underpinning the test and device and formulating an IP and trademark strategy towards commercialisation. Saberi Marais, UCT’s Innovation Commercialisation Manager, is assisting the inventors with the technology development planning, funding applications, and validating the market need.