Dr Baker on the EMBRACE Trial of the Dxcover Liquid Biopsy in Brain Cancer

"The use of our test in the primary care population would enable the patients who have a brain tumor to be urgently referred for a diagnostic complementary scan. There is a vast population of patients who do not have a brain tumor in this pathway, which is using up difficult resources. We want to free up [these resources] and make [testing] more economical, but also save the psychological impact for those patients who do not have a brain tumor."

Matthew J. Baker, PhD, professor, Early Diagnostics, University of Central Lancashire School of Medicine, United Kingdom; president, chief executive officer, Dxcover Ltd, discusses the ongoing investigation of the Dxcover Liquid Biopsy for patients with brain cancer in the observational EMBRACE study, and how this test could better inform clinical decision-making for high-risk patient populations.

The Dxcover Liquid Biopsy is a multi-omic diagnostic tool that uses infrared spectroscopy to analyze blood samples and generate a unique biomolecular signature sensitive to the hallmarks of brain cancer. This technology can be adjusted for higher sensitivity or specificity based on clinical needs and healthcare market demands. In initial feasibility studies involving 988 patients presenting with non-specific symptoms, the algorithm demonstrated 96% sensitivity for detecting brain tumors and 100% sensitivity for glioblastomas (GBM) when optimized for sensitivity.

EMBRACE is a prospective, observational, multicenter trial designed to evaluate the clinical performance of the Dxcover Liquid Biopsy, Baker begins. Conducted across seven sites in the United Kingdom, Belgium, Sweden, and Switzerland, the study aims to recruit at least 2200 participants over 24 months. The target population includes patients presenting with non-specific symptoms indicative of potential brain cancer in primary care, such as persistent headaches or new-onset neurological deficits, Baker details. The primary objective is to assess the diagnostic sensitivity and specificity of the liquid biopsy compared with standard diagnostic imaging, including CT or MRI, he states.

The Dxcover test offers significant potential to streamline the brain tumor diagnostic pathway by facilitating early detection and triage in primary care, Baker says. For patients with brain cancer, the liquid biopsy enables expedited referral for confirmatory imaging, ensuring timely diagnosis and treatment initiation, which are critical for reducing associated morbidity and mortality. Conversely, for patients without brain tumors, the test could help avoid unnecessary imaging, alleviating resource strain on healthcare systems and reducing the psychological burden associated with brain tumor evaluations, he adds. Furthermore, for individuals with neurological symptoms not indicative of a brain tumor, the test may support faster referral to appropriate diagnostic pathways, allowing for more efficient identification and management of alternative neurological conditions, Baker emphasizes.

Incorporating this simple, non-invasive liquid biopsy into primary care could improve the efficiency and accuracy of brain tumor pathways while optimizing healthcare resource utilization and enhancing patient outcomes, Baker concludes.