This new lateral flow finger prick sample test could be used to rapidly identify high-risk patients in the ER or at the bedside, thereby greatly expanding the potential market beyond centralized lab testing. It also has strong potential in countries worldwide with less developed centralized laboratory infrastructure.

Dr Andrew Retter, Critical Care Lead and Medical Consultant, Volition, said: "This is a huge step forward toward our goal of making Nu.Q® NETs an easily accessible, cost-effective, minimally invasive test.

"We measured H3.1 nucleosomes in critically ill patients with sepsis, comparing a finger-prick sample read on a lateral flow device with our CE-marked laboratory assay on plasma. The two tracked closely, with 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.

"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."

Dr. Gaetan Michel, Chief Operating Officer, Volition said: "This prototype technology has the exciting potential to strengthen our product portfolio. With recent estimates indicating approximately 166 million cases of sepsis worldwide, the potential addressable market is huge. All-cause sepsis related deaths in 2021 represented 31.5%2 of total global deaths, with the highest burden of mortality in lower-middle-income countries."

"This is a potential gamechanger, not only in diseases where time is critical such as sepsis, but also in significantly expanding potential use cases beyond traditional hospital infrastructure.  It also creates a compelling pathway into underserved low-income countries, where laboratory infrastructure may be weak or non-existent.

"By enabling decentralized testing, our total addressable market expands, and we are actively targeting NGO partnerships and strategic collaborations with companies operating in low income countries to accelerate commercialization and market penetration. "We are excited to announce this breakthrough and look forward to sharing further details of the study and commercial updates throughout the year."

Volition has previously announced results demonstrating not only correlation between whole venous blood (standard blood draw from the arm) samples utilizing its lateral flow prototype, and those of Volition's established automated Nu.Q® nucleosome assay performed in a central laboratory but also more recently, the successful detection of nucleosomes in capillary blood.

This study, part of the SUMMIT program, tested both capillary blood and plasma blood samples from hospital patients in Intensive Care using the lateral flow finger-prick prototype and the CE-marked automated assay and demonstrated significant correlation between the two formats. Results showed the feasibility of early detection of immune disruptions that can occur in a range of conditions including sepsis, simply and rapidly when using the test in a variety of settings (doctor's office, Emergency Department, Intensive Care Unit setting, or home self-test), without the need to send a blood sample to a hospital laboratory for testing.