501TiP - Clinical performance evaluation of a brain cancer liquid biopsy

Background

Diagnostic delays impact the quality of life and survival of patients with brain cancer. Earlier and expeditious diagnoses in these patients are crucial to reduce the morbidities and mortalities associated with brain cancer. Currently, with no blood test to assist them, clinicians must make their referral decision based on symptoms. Existing symptom-based referral guidelines inadequately stratify patients for brain imaging based on suspicion of cancer. A simple, rapid liquid biopsy that could be administered in a primary care setting would enable more efficient triage of patients with non-specific symptoms related to brain cancer. The most at-risk patients could then be fast-tracked for urgent brain imaging. The Dxcover Liquid Biopsy is a rapid multi-omic liquid biopsy that interrogates a blood sample with Infrared (IR) radiation and produces a distinctive signature that represents the whole biomolecular profile of the sample. The nature of the technology also allows for the diagnostic models to be tailored towards higher sensitivity (or specificity) depending on clinical priorities and international healthcare markets. In initial feasibility studies, we recruited 988 patients prospectively with non-specific symptoms associated with a brain tumor, and the algorithm detected 96% of the patients with brain tumors and 100% of glioblastomas (GBM), when tuned for greater sensitivity. This simple, non-invasive liquid biopsy would facilitate the triage of brain tumor patients for rapid imaging.

Trial design

EMBRACE is a prospective, observational, multicenter study, currently recruiting patients across seven sites in the United Kingdom, Belgium, Sweden and Switzerland. The study duration is 24 months and will recruit a minimum of 2200 participants. The target population is comprised of patients presenting to primary care with non-specific symptoms that are associated with brain cancer, such as headaches, seizures and new onset neurological defect. The primary objective is to determine the clinical performance of the liquid biopsy for patients with brain cancer, in terms of diagnostic sensitivity and specificity. The test performance will be determined by comparing the liquid biopsy result to the reference method (diagnostic imaging).

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Dxcover Limited.

Funding

Dxcover Limited.

Disclosure

J.M. Cameron: Financial Interests, Personal, Full or part-time Employment, Employed staff member for Dxcover Limited: Dxcover Limited. G. Antoniou: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited. P. brennan: Financial Interests, Institutional, Advisory Role: Dxcover Limited, Dxcover Limited; Financial Interests, Institutional, Research Funding: QV Bio Ltd, QV Bio Ltd. H. Butler: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited; Financial Interests, Personal, Leadership Role: Dxcover Limited; Financial Interests, Personal, Stocks or ownership: Dxcover Limited. D. Eustace: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited; Financial Interests, Personal, Leadership Role: Dxcover Limited. E. Gray: Financial Interests, Personal, Financially compensated role: Dxcover Limited, Grail; Financial Interests, Personal, Advisory Role: Dxcover Limited; Financial Interests, Personal, Full or part-time Employment: Grail. M. Jenkinson: Financial Interests, Personal, Advisory Board: Servier, yTomorrows, GSK. A. Lazarus: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited. R. Mathew: Financial Interests, Personal and Institutional, Other: SamanTree, SyncVR; Financial Interests, Personal, Speaker’s Bureau: Baxter; Financial Interests, Personal, Ownership Interest: RBM Healthcare, NeuroTips, Assemblify; Financial Interests, Personal, Advisory Board: Stryker, BrainLab, Opto, Servier. D. Palmer: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited; Financial Interests, Personal, Leadership Role: Dxcover Limited; Financial Interests, Personal, Stocks or ownership: Dxcover Limited; Financial Interests, Institutional, Research Funding: GSK, Pfizer, Endofotonics. A. Sala: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited. M.J. Baker: Financial Interests, Personal, Full or part-time Employment: Dxcover Limited; Financial Interests, Personal, Leadership Role: Dxcover Limited; Financial Interests, Personal, Stocks or ownership: Dxcover Limited. All other authors have declared no conflicts of interest.