Prototype Point-of-Care Lateral Flow Test Aims to Improve Neonatal Sepsis Triage

Sepsis in newborns and young infants remains a major clinical challenge, particularly in low- and middle-income countries. An estimated 2.3 million newborns die each year, with sepsis contributing substantially to mortality in regions such as Africa, where the burden is greatest. To support earlier and more accessible detection, a new collaboration aims to evaluate a finger-prick lateral flow prototype for decentralized testing of NETosis.

VolitionRx Ltd. (Henderson, NV, USA) has signed a non-binding Letter of Intent (LOI) with Missionpharma A/S (Vassingerød, Denmark) to explore the potential development and global launch of Volition’s prototype Lateral Flow Technology (LFT) for NETosis. Under the proposed collaboration, the companies plan to evaluate the introduction, development, and scale-up of the test, with Missionpharma potentially supporting low-cost manufacturing, clinical studies, and distribution.

Missionpharma supplies healthcare products and innovative solutions to United Nations agencies, international and local non-governmental development organizations, and public and private sector institutions. Its partners include the World Health Organization and ministries of health across low- and middle-income countries, providing an established network that could support broader access to the LFT test.

The Nu.Q NETs test measures circulating nucleosomes and neutrophil extracellular traps (NETs), which can serve as early indicators of hyperinflammation. In critically ill patients with sepsis, results from the lateral flow prototype were reported to correlate closely with those from Volition’s established automated Nu.Q NETs test, supporting further evaluation of the point-of-care format.

The initial clinical focus is expected to be the development and validation of a tool for triage and prognostication in neonatal sepsis. Severe infections remain a major cause of newborn mortality, and previous studies have estimated that 84% of these deaths could be prevented if tools for earlier diagnosis and patient management were available.

“At Missionpharma, we are proud to have strong partnerships with a broad institutional base, including United Nations ("UN") agencies specialized in global health and humanitarian response. We aim to explore opportunities to closely work with Volition in the introduction, development, and scale-up of its LFT test for NETosis, potentially assisting with low-cost manufacturing, clinical studies, and distribution,” said Agustin Travaini, Director, Strategic Partnerships, UN, Missionpharma.

“We see a very strong interest from our partners and customers in Volition's innovative diagnostic solutions, particularly in low- and middle-income countries ("LMICs") and humanitarian emergency settings, and are excited to collaborate with the aim of saving millions of children's lives annually,” added Travaini.

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