Groundbreaking Lateral Flow Test Quantifies Nucleosomes in Whole Venous Blood in Minutes

Traditional testing methods can be slow, expensive, and require sending blood samples to a hospital laboratory, delaying treatment decisions. In particular, intensive care and emergency department settings often face challenges in quickly identifying high-risk patients for conditions such as sepsis. Now, a new study has demonstrated that nucleosomes, a key biomarker of immune disruption, can be quantified rapidly and simply using a lateral flow device, offering a potential solution to speed up diagnosis and enhance clinical decision-making.

VolitionRx’s (Henderson, NV, USA) Nu.Q nucleosome assay is a chemiluminescent immunoassay (ChLIA) that aids in the detection and evaluation of diseases associated with NETosis, a unique form of cell death. VolitionRx has developed a lateral flow device that quantifies nucleosomes directly from venous blood samples in minutes. The device was tested in a blinded study with blood samples from 25 hospital patients in intensive care and emergency departments. The study, part of the SUMMIT program, demonstrated the feasibility of using the lateral flow device for early detection of immune disruptions linked to conditions like sepsis.

The study showed that the device could be used to identify high-risk patients more efficiently. This breakthrough is expected to improve patient outcomes by enabling quicker clinical decision-making. The results correlated strongly with those of Volition's established automated central laboratory Nu.Q nucleosome assay, which is already used for disease monitoring. The device could be used in a doctor's office, emergency department, or intensive care setting, enabling the rapid identification of patients with immune disruptions without needing to send samples to a laboratory. The next phase of the SUMMIT program will focus on developing a capillary blood-based version of the test, with the goal of providing a finger-prick test for additional use cases.

"The ability to rapidly identify high-risk patients at the Point-of-Care by quantifying their nucleosome levels using a simple lateral flow device could enable quicker clinical decision making and consequently better patient outcomes," said Gael Forterre, Chief Commercial Officer at VolitionRx. "This is a potential gamechanger, not only in diseases where time is critical such as sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or non-existent.”

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