ASEP Medical Holdings Inc. announced the ground-breaking use of artificial intelligence (AI) to rapidly identify infections at increased risk of severe sepsis. The method was developed by the Hancock Lab, under the guidance of Dr. Robert E.W. Hancock, Killam Professor at the University of British Columbia (UBC), and analyzes the dysfunctional immune responses involved in sepsis to identify sets of genes that help assess whether a patient will acquire severe sepsis.

This confirmatory clinical trial will precede a larger study to demonstrate the performance of Sepset, the Company’s sepsis diagnostic technology, and compare it to currently available sepsis tests in anticipation of filing a 510(k) submission with the FDA seeking clearance for the test as a medical device.

ASEP Inc. anticipates that the 510(k) application process will be complete in Q1 2024, and the test should be available to hospitals soon after.

AI methods were applied and proved to be 97% accurate in identifying which of the five sepsis endotypes occurred in each patient.

These biomarkers also worked in the ICU, where it was shown that one endotype was particularly deadly, with a mortality rate of 46%.

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