A simple blood test is being developed that could predict graft-versus-host disease (GvHD) or detect it early, reducing serious transplant complications. GvHD is the main cause of complications following transplants from donors, and almost doubles transplant costs. The Nu.Q® project has adapted an existing cancer test to detect the disease and accurately diagnose its severity.
GvHD is particularly common in patients who have received bone marrow or stem cell transplants as part of treatment for leukaemia and other cancers. It occurs when cells transplanted from one person into another develop an immune response against the host.
The test developed in Nu.Q® detects fragments of cell chromosomes – called nucleosomes – that dying cells produce in unusual volumes during transplant rejection and other diseases. It measures and analyses them to establish whether the patient has GvHD and if so, how severe it is. This could allow doctors to diagnose and monitor the disease more accurately and tailor anti-rejection medication, improving outcomes for patients and better targeting healthcare resources.
Underpinning the test is technology developed by Nu.Q®’s main partner, SME Belgian Volition to screen for colorectal cancer, tailored to GvHD with UK drug-testing specialist Alconymics. Although the test is based on the latest epigenetics research, the measurement itself is simple, accessible and low cost, says Mark Eccleston, Belgian Volition’s Business Development Director. “It uses the same principle as a pregnancy test.”
It is also highly accurate, achieving 80% sensitivity in detecting GvHD and 83% accuracy in indicating its severity, he adds. Further validation studies are needed before the tests can be marketed, but this is higher than other biomarkers researched for this purpose, he says.
A reliable test is urgently needed. Over 80 000 EU citizens develop leukaemia each year. Many go on to require cell transplantation when radiotherapy or chemotherapy damages their own immune system. GvHD affects 16 000-32 000 of these and kills 2 400-13 000. Meanwhile a transplant usually costs EUR 90 000, but if complications arise, this can grow to EUR 150 000-180 000.
Looking further ahead, the research could help improve outcomes from transplants of solid organs such hearts or kidneys. In addition, Belgian Volition developed new assays and a new sensitive test format within the programme.
The company already has experience of combining public and private investment. It was established in 2010 with private funding to develop simple blood-based diagnostic tests that combine established technology with nucleosome detection and analysis. Volition then listed on the New York Stock Exchange in 2015, allowing three further public funding rounds. “Being listed opens doors in terms of our credibility,” says Eccleston. “It gives us access to funds for trials and reassures investors.”
Public funding created space to explore new ideas. “The Eurostars project gave us the flexibility to adapt our existing research to transplant rejection…. we could explore something that was not central to the original mission.” He adds that the company has also had strong financial support from Belgium’s Walloon region, where it is based.
The company has kept an eye on costs for large scale diagnostic trials to make the most of its funding. It has done so through clinical collaborations at university hospitals to access data for testing. “We have had good partners,” says Eccleston. “We always want to collaborate with other people. We have supported H2020 programmes and are always looking for new partners.”