EDX Medical has unveiled a groundbreaking non-invasive prostate cancer diagnostic innovation, offering potential to significantly enhance early detection and treatment personalisation. Positioned as a transformational advance, the test not only detects cancerous cells but also precisely distinguishes early-stage from advanced cancer, determines disease aggression, and assesses genetic and hereditary risk factors in patients.
Based in Cambridge, UK, EDX’s pioneering diagnostic evaluates an unprecedented 100 clinically validated prostate cancer biomarkers from patient blood and urine samples, substantially outperforming existing advanced tests that typically assess up to 20 biomarkers. This expansive biomarker analysis is subsequently interpreted through a sophisticated, custom-designed artificial intelligence (AI) algorithm, which rapidly provides comprehensive diagnostic reports to healthcare providers.
Further differentiating its approach, EDX integrates multi-omics technology—simultaneously evaluating proteomic, transcriptomic, genetic, and epigenetic signatures alongside phenotypic and symptomatic patient data. The result is a comprehensive diagnostic landscape delivered via AI-driven insights, streamlining clinical decision-making and drastically reducing the need for unnecessary invasive procedures, such as MRI scans and digital rectal examinations (DRE).
EDX Medical anticipates an unprecedented accuracy range of between 96% and 99%, applicable across diverse age groups and ethnicities—a significant leap forward from the current prostate-specific antigen (PSA) tests and biopsies, which offer accuracy often below 50% and are prone to false positives. EDX’s innovative approach could dramatically enhance clinical outcomes, empowering clinicians to provide highly targeted, patient-specific treatment strategies.
The company’s founder and Chief Scientific Officer, Chris Evans, emphasised the test’s transformative potential, highlighting its capability as the most sensitive and accurate screening method currently known, particularly valuable for identifying disease in asymptomatic men. EDX has already filed patent applications for both the test and its proprietary AI-driven analytics platform with the European Patent Office, laying a strong foundation for international commercialisation.
Pending further clinical validation, EDX Medical plans to seek regulatory approval from the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), with an anticipated launch either late this year or early in 2026. This strategic timeline positions EDX to capture a significant share of the prostate cancer diagnostic market, offering investors a promising entry into a sector poised for disruption.
EDX Medical Group Plc (AQSE:EDX) is a global specialist in digital clinical diagnostics; developing and supporting high-performance products and services to provide cost-effective prediction of disease risk, inform clinical decision-making, enable personalised healthcare and accelerate the development of new medicines for cancer, neurology, heart disease and infectious diseases.
