Study results show finger-prick lateral flow prototype matches performance of automated nucleosome measurement in critically ill patients.
VolitionRx Limited announced that results from its lateral flow prototype for sepsis are highly correlated with its established automated Nu.Q NETs laboratory test. The findings suggest the finger-prick sample test could identify high-risk patients at the point-of-care, potentially reducing dependency on centralized laboratory testing.
The study, part of the SUMMIT (Sepsis: addressing unmet needs for disease monitoring with a rapid test) program, compared H3.1 nucleosome measurements in critically ill patients. Researchers compared capillary blood samples read on a lateral flow device with a CE-marked laboratory assay performed on plasma. The two methods showed a Spearman correlation of 0.85 and a Pearson correlation of 0.881.
“This is a significant step forward and a different kind of test from the one we have today. It materially reduces barriers to testing patients and facilitates nucleosome measurement at the bedside,” says Andrew Retter, critical care lead and medical consultant at Volition, in a release. “The ability to rapidly identify high-risk patients at the Point-of-Care by quantifying their nucleosome levels using a finger-prick sample and simple lateral flow device could enable quicker clinical decision making and consequently better patient outcomes.”
The lateral flow device is designed for use in emergency departments, intensive care units, or doctor offices. According to the company, decentralized testing could expand the addressable market for NETosis testing, particularly in regions with less developed laboratory infrastructure.
“This prototype technology has the exciting potential to strengthen our product portfolio,” says Gaetan Michel, chief operating officer at Volition, in a release. “By enabling decentralized testing, our total addressable market expands, and we are actively targeting [non-governmental organization] partnerships and strategic collaborations with companies operating in low income countries to accelerate commercialization and market penetration.”
The Nu.Q NETs assay is a chemiluminescent immunoassay that currently runs on the Immunodiagnostic Systems i10 automated analyzer platform. It holds a CE Mark for the detection and evaluation of diseases associated with NETosis, including sepsis, and is available in 27 European countries. The SUMMIT project is carried out with financial support from the Walloon Region.
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