Clinical Validation

Discovery and Verification

Presymptom and the Ministry of Defence Science & Technologies Laboratory have collectively conducted 4 discovery and verification studies encompassing a total of over 5,000 patients.

The technology behind the Presymptom’s tests started more than 15 years ago at the Defence Science and Technology Laboratory (Dstl) and included the largest patient study of its kind. This study was published in October 2022 (link). The study recruited a total of 4,385 patients and was designed to identify and predict those likely to develop infection and sepsis. From the 72,734 patient samples taken, a unique clinical biobank and database were generated and then mined using machine learning to identify biomarker signatures that could predict the onset of infection and sepsis. The resulting signatures were shown to be able to provide an early warning of infection and sepsis up to three days ahead of illness with an accuracy of up to 90%.

The foundational study was the result of a multi-site collaboration by a group of 103 clinicians and researchers.

Verification Studies

Presymptom has conducted Verification studies in 7 in-silico NIH and ECBI datasets encompassing 513 sepsis and control patients, demonstrating high accuracy in all viral and bacterial datasets.

Presymptom has participated in the EU-funded 62-patient SEPTIMET study, again demonstrating the ability to clearly identify sepsis patients vs controls.


Validation Studies

Presymptom is engaged in validation studies encompassing nearly 1,000 patients, including PRECISION and an EU study currently in setup.

PRECISION is a multi-centre observational cohort study recruiting up over 400 hospitalized patients with Acute Lower Respiratory Tract Infections and a further 100 hospitalized patients without infection. Patients provide informed consent to participate in the study. Daily blood sample collection are conducted for up to 4 days, starting at admission. Anonymized patient demographic data, all clinical measures and outcome data generated during routine clinical care will be retrospectively collected. Outcomes will be censored to seven days. Clinical adjudicators review each case to determine if the Sepsis-3 criteria for acute organ dysfunction had occurred and the likely cause, together with infection status. Interim data analysis was performed after the recruitment of 150 patients.

PRECISION is designed to determine the accuracy of Presymptom Health’s gene host response biomarker signatures to predict organ dysfunction/failure in all ALTRI patients, and to support comparative analysis between infected and uninfected groups. The study is powered to assess endpoints of infection status, clinical deterioration and sepsis. Outcome measures being tracked include intensive care, coronary care, respiratory high care admission, organ support (Organ support (inotropes, ventilation support, renal) and end of life care decisions. Acute organ dysfunction is identified according to conventional criteria, namely an increase in the Sequential Organ Failure Assessment score (SOFA score) of 2 or more from baseline at the time of recruitment to the study.

PRECISION recruitment is anticipated to conclude in Q1, 2024.

The PRECISION trial has been reviewed by the Research Ethics Council and the Health Research Authority (REC number: 21/SC/0048).

Presymptom will achieve first regulatory clearance of its infection rule-out product in 2025.

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