The spin-out speeding up diagnostics

“There is a bottleneck,” says Bob Roopra, the company’s Chair, who has spent more than twenty-five years in the diagnostics industry.

While there are already well-established techniques such as lateral flow tests, ELISA, PCR and LAMP, the difficulty is working out how to optimise the many parameters involved in developing an assay for a particular target. Roopra explains that “the rules for optimisation are not written down, so development can depend heavily on the expertise of one or two people."

The origins of AssayGen can be traced back to University of Birmingham research during the COVID-19 pandemic. Professor Jim Tucker from Chemistry and Professor Tim Dafforn in Biosciences combined their approaches to nucleic acid sensing and detection technology, with input from Dr Jean-Louis Duprey, now the company’s CEO.

This led to a new collaborative project at the university undertaken with PhD student Ana Mikić, in work that brought in engineering expertise from Associate Professor Rob Simpson. Mikić’s PhD focused on developing and optimising nucleic acid diagnostic technologies by streamlining the existing pipelines using novel computational tools. This combination of biomolecular and computational sciences has provided the foundation for AssayGen’s new approach to assay development.

The potential application extends beyond infectious diseases. For example, pharmaceutical companies need diagnostic tests alongside new drugs, including companion diagnostics that can establish whether a treatment is working or identify patients likely to respond. Diagnostics manufacturers may also have assays that work in principle but have proved too difficult to optimise for commercial use. In public health and defence, too, there is always the potential need to develop tests quickly in response to a new or engineered pathogen.

The conventional diagnostic development pipeline involves several stages, from identifying a disease and its molecular target through assay development and optimisation to product development and clinical trials. AssayGen is focusing on the second stage, using a computational approach and machine learning-based assay design.

The approach that began during Mikić’s PhD was subsequently refined with the University through an EPSRC-funded Impact Acceleration Account award, which connects UK-registered small and medium-sized enterprises (SMEs) with measurement scientists and research facilities to solve tricky technical, measurement, or analysis problems. The University’s Advanced Research Computing team has helped automate disparate workstreams. Led by Thomas Neep and Heather Turner they have created a fast and efficient platform for the company’s optimisation approach.

The story of AssayGen reflects the vibrancy of the West Midlands life sciences ecosystem. “Five years ago it was very fragmented,” comments Roopra. "Companies and universities were often working in relative isolation, with limited awareness of what expertise or resources were available elsewhere in the region."

Roopra believes the West Midlands Health Tech Innovation Accelerator helped to change that by bringing organisations together and creating opportunities for collaboration. Since then, Duprey describes a growing network of relationships between universities and companies across the region, including work with Aston University and Birmingham City University.

Birmingham brings strengths in areas including clinical science and biosciences, while institutions such as Aston, Warwick, Loughborough and Birmingham City University contribute complementary expertise in engineering, optical sciences, data and computing. The opportunity, for Roopra, is in connecting these strengths.

The University of Birmingham plays a key role in commercialisation. AssayGen’s core Intellectual Property originated in University research, and the company has been established to commercialise that work rather than develop an entirely separate technology.

For Roopra, who has mentored students for around a decade, commercialisation serves a wider purpose. He sees successful spin-outs as a way of creating opportunities for students and building the next generation of companies in the region. “I’d like to build a company like AssayGen to bring in the students, to give them jobs, and use our expertise to help them commercialise,” he says.

The ambition extends beyond developing a faster way to design diagnostic tests. It is about creating connections between research, business and the people who will build the next generation of life sciences companies.

While AssayGen is still at the beginning of its commercial journey, this story points to something larger happening in Birmingham and across the West Midlands region. Research that once sat within individual laboratories is increasingly being connected to companies, investors and expertise elsewhere in the region. The challenge now is to turn those connections into a pipeline of new businesses and new technologies.