Democratizing Virus Testing

PCR kit produced at KAUST with local content is on the cusp of commercialization

In the early days of the COVID-19 pandemic, Samir Hamdan, Associate Professor of Bioscience at KAUST, and his colleagues in the Rapid Research Response Team knew that diagnostic bottlenecks would be one of the most significant obstacles in fighting the virus. Even though there were already many commercially available reverse transcription polymerase chain reaction (RT-PCR) tests on the market, their high cost and scarcity due to airport closures and shipment restrictions left public health initiatives in many countries vulnerable. To address this problem, Professor Hamdan and his team decided to produce the key components of RT-PCR testing kits locally. A year later, their in-house kit is being deployed in the field to scale up the Kingdom’s testing capabilities.

“The authority strongly supports the development of local biotechnology and innovative medical devices, including in vitro diagnostic devices such as the new COVID-19 test kit that was developed by national laboratories and research centers. Our support is extended to all biotech applications developed locally and overseas by assessing their compliance with authority requirements for safety and efficiency.”

SAMIR HAMDAN Associate Professor of Bioscience

OUR VIRUS TESTING KIT IS ESPECIALLY NOTABLE BECAUSE WE PROVIDE MANUFACTURING DETAILS PATENT-FREE.

The testing kit developed by Professor Hamdan and his team involved years of hard work in KAUST’s labs. Prior to the pandemic, he led a group in the school’s Biological and Environmental Science and Engineering (BESE) division that had successfully established a robust production line of DNA polymerases in their laboratory. These efforts proved vital after the outbreak of COVID-19, when it became clear that the world was facing an unprecedented global health crisis with rapidly increasing demand for medical equipment and tests.

Most commonly used test kits require reverse transcriptases and DNA polymerases – chemical reagents that amplify the viral genomic RNA to detectable levels. However, surging global demand for testing in 2020 put significant strain on the laboratories that produce these reagents and other enzymes used in tests. Adapting their work to the new crisis, the BESE group quickly set about developing reagents for SARS-CoV-2 tests for use in biomedical and clinical labs.

Since most of the chemical agents used in RT-PCR test kits are protected by patents, the researchers’ first challenge was to develop easy and economical methods to produce patent-free, specifically tailored versions of these chemical agents. Once a large-scale, steady supply of patent-free reagents was established, the next step was to design an in-house virus detection kit. KAUST’s RT-PCR testing kit was then put through rigorous trials in laboratory settings in collaboration with labs from the Ministry of Health, and then in testing facilities at King Faisal Specialist Hospital and Research Center, and the Saudi Public Health Authority. The results were promising: the kit was routinely able to reliably detect as few as 10 copies of the synthetic RNAs of SARS-CoV-2. More importantly, the kit successfully detected COVID-19 in clinical samples of broad viral loads with similar reliability and selectivity to that of commercially approved kits. Within a few months, Professor Hamdan and his team, in collaboration with the Saudi Public Health Authority, had received regulatory approval from the Saudi Food and Drug Authority. The kit is now being deployed for a large-scale study led by NoorDx, a KAUST-based diagnostics start-up, in collaboration with US scientific instrument manufacturer Thermo Fisher, which is a strategic partner of KAUST Core Labs. The support of the Saudi Public Health Authority, the Saudi Food and Drug Authority, and the Ministry of Health was key to local pharmaceutical firms expressing interest in commercializing the kit.

In time, it is hoped that this economical, versatile, in-house, one-step RT-PCR test kit will democratize diagnostics and aid efforts to combat the spread of COVID-19. Its rapid development and deployment over the course of 12 months has showcased the R&D capabilities of KAUST and the wider Kingdom. The project also bodes well for the future development of locally designed and manufactured medical devices and other products – an important element in the Kingdom’s Health Care Transformation Strategy under the Vision 2030 framework.