Study to Measure Cell-Free DNA Capture Potential of BioCaptis Device

BIOCAPTIVA Ltd. has begun an ex-vivo study to determine whether its BioCaptis device can isolate pleural fluid cell-free DNA (cfDNA) from exudative pleural fluid samples in sufficient quantities to improve pleural disease diagnosis. The study will involve a collaboration between BioCaptiva, University of the Highlands and Islands (UHI), and NHS Highland.
 
“The diagnosis of pleural disease is challenging, and fluid sampling is often inconclusive due to low tumour cell content, with further invasive biopsies often required that are themselves common causes of hospital-based admission and patient morbidity, meaning there is a need for alternative non-invasive procedures. Due to its ability to increase the amount of cell-free DNA (cfDNA) available for liquid biopsy testing, our BioCaptis device has the potential to significantly expedite pleural disease diagnosis times while at the same time reducing overall risks and costs, giving patients the best opportunity for a positive health outcome,” BIOCAPTIVA CEO Jeremy Wheeler said. 
 
Pleural disease is an umbrella term defined by the presence of lung lining thickening or fluid between the chest wall and lung itself. It encompasses multiple conditions including cancer, infection, and auto-immune disease.
 
The occurrence of cfDNA in exudative pleural fluid samples is well-established, but it is often present in insufficient concentrations for sequencing to confirm a cancer diagnosis (versus benign disease).  Although many patients presenting with pleural disease will have an underlying malignancy, only 60% of these are diagnosed through routine pleural fluid sampling with the remainder having to undergo invasive biopsy sampling which carries additional risks and can also be inconclusive. This route to diagnosis is particularly challenging for frail elderly patients and therefore improving the diagnostic utility of pleural fluid has both clinical and health economic benefits.
 
“Patients with cancers affecting the lungs frequently have a large build-up of fluid around the lungs, which is drained as part of standard clinical care,” stated Principal Investigator and UHI Assistant Professor Antonia Pritchard, reader in Genetics and Immunology. “This collaboration between BioCaptiva, UHI, and NHS Highlands to investigate the use of the BioCaptis to isolate cell-free DNA from this fluid has the goal of identifying tumour specific mutations to aid diagnosis of the type of cancer present without requiring invasive biopsy.”

The BioCaptis captures up to 100 times more cfDNA than a venous blood draw, yielding cfDNA in high quality and quantity for testing, addressing the major challenge of liquid biopsy in cancer management. This will potentially allow the testing of a far greater number of cancer types and stages in a much wider range of patients.
 
“We’re delighted to have been invited by BioCaptiva to help investigate their technology in detecting a specific type of lung cancer that is currently very difficult to diagnose. Collaboration is at our core and this work that brings together clinicians, UHI researchers and a company with technology to improve early diagnosis is an excellent example of the strength of this approach,” added UHI Professor Ian Megson, head of Health Research and Innovation.
 
BIOCAPTIVA is developing the BioCaptis, a medical device that potentially could transform liquid biopsy testing for cancer management. BIOCAPTIVA was founded in 2021 as a spinout from the University of Edinburgh; the Edinburgh-based firm is backed by Archangels Scottish Enterprise, Cancer Research Horizons, the new innovation engine of Cancer Research U.K. and Old College Capital, the University of Edinburgh’s in-house venture investment fund.
 
UHI is a regional further and higher education partnership, serving the Highlands and Islands communities of, Moray and Perthshire. It covers the largest geographical area of any campus-based university or college in the U.K. and has one of the largest student populations in Scotland, with more than 36,000 students studying each year. The university contributes £560 million annually to the Highlands and Islands, Moray and Perthshire economies, and supports 6,200 jobs.