Edx Medical pioneers multi-biomarker testing approach for prostate cancer detection
Cambridge scientists at EDX Medical Group have developed an innovative diagnostic test for prostate cancer that combines over 100 biomarkers with AI analysis, potentially transforming screening accuracy with sensitivity and specificity rates between 96-99%.
Revolutionary multi-omics methodology advances diagnostic capabilities
The newly developed diagnostic protocol represents a significant leap forward in prostate cancer detection technology by simultaneously assessing proteomic, transcriptomic, genetic and epigenetic biomarker signatures from both blood and urine samples. This comprehensive multi-omics approach enables clinicians to create detailed profiles of prostate cancer status with unprecedented accuracy.
Each biomarker incorporated into the test has undergone rigorous independent validation through extensive clinical trials, involving more than 31,000 positive prostate cancer samples and 100,000 control samples. The test’s proprietary AI algorithm integrates these molecular signatures with phenotypic and symptom data to generate comprehensive diagnostic reports.
“Our integrated approach highlights the potential of combining these molecular signatures, offering a powerful, non-invasive diagnostic tool that can certainly improve clinical outcomes and help personalise treatment for patients,” explained Professor Sir Chris Evans, founder and chief scientific officer of EDX Medical.
Addressing critical limitations in current testing protocols
The innovative approach directly tackles well-documented shortcomings of traditional prostate-specific antigen (PSA) testing, which research has shown to be unreliable for definitive diagnosis. Current data indicates approximately 70% of men with elevated PSA levels do not have cancer, while around 20% with normal or low PSA measurements may have undetected malignancies, often of aggressive subtypes.
This diagnostic gap has significant clinical implications, leading to both missed cancer diagnoses and unnecessary interventions. The EDX test aims to drastically reduce these false positives and negatives through its multi-parameter approach.
Potential to transform clinical pathways and reduce invasive procedures
Implementation of this comprehensive testing methodology could potentially streamline diagnostic pathways by reducing the need for invasive procedures including digital rectal examinations and unnecessary MRI scans. The non-invasive nature of the blood and urine sampling makes it particularly suitable for integration into population screening programmes.
Dr Mike Hudson, chief executive of EDX Medical, stated: “I’m confident that the EDX testing strategy will define a new standard for the early detection and characterisation of emergent, prostate cancer, and provide unique insights to guide optimal treatment selection.”
Clinical validation timeline and regulatory strategy
The EDX scientific team plans to validate additional clinical data over the coming months before pursuing regulatory approvals from the Medicines & Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA). Commercial availability is projected for late 2025 or early 2026.
Intellectual property protection has been initiated through a patent application filed with the European Patent Office, covering both the comprehensive test methodology and its AI algorithm. This patent protection emphasises the distinctive analytical approach that differentiates this test from competitors typically relying on significantly fewer biomarkers.
Epidemiological significance
The development addresses a substantial clinical burden across Europe, with approximately 55,000 new prostate cancer cases diagnosed annually in the UK and more than 330,000 across European Union countries. At any given time, more than one million men are undergoing treatment for the condition.
The test developers suggest it may provide particular benefits for high-risk demographic groups, including non-Caucasian men who demonstrate higher rates of advanced and aggressive disease presentations.
For more information, visit: www.edxmedical.com
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