Scientists in Cambridge have developed a new ‘super test’ for prostate cancer in an effort to revolutionise screening and diagnosis of the disease and accelerate personalised treatment for patients.
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Prostate Cancer awareness.
The test identifies the presence or absence of cancerous cells, signs of early and late-stage cancer, whether it is slow or aggressive as well as genetic and hereditary risks in the patient.
The new test involves studying the most comprehensive combination of clinically-validated prostate-related biomarkers currently known, in both blood and urine samples. The interpretation of these biomarkers using a proprietary AI-driven algorithm highlights early signs of cancer and characteristic features that can guide treatment selection.
There are 55,000 new cases of prostate cancer in the UK each year, more than 330,000 across European Union countries and more than one million men undergoing treatment at any one time.
More than 100 clinically validated biomarkers are measured in the new test – which has been developed by EDX Medical Group plc. The biomarkers used in the test are then analysed by the specially created AI-powered algorithm which produces a detailed report of results for doctors. Currently available advanced tests which rely on up to 20 biomarkers per test.
EDX Medical scientists expect the test to consistently deliver exceptionally high accuracy with levels of sensitivity and specificity of between 96-99% across an extended age-range and diverse ethnic groups. By comparison, current standard of care prostate testing, including prostate specific antigen (PSA) tests and biopsies, can be below 50%.
The non-invasive ‘super test’ will detect various sub-types of prostate cancer determining key features particularly important for patients in non-caucasian higher risk groups.
The super test takes a ‘multi-omics’ approach and comprises a combination of multiple proteomic, transcriptomic, genetic/hereditary and epigenetic biomarker signatures which provide detailed biological data. A comprehensive list of phenotypic and symptom data is added to the biomarker data and is simultaneously analysed by the AI algorithm.
Individually, these biomarkers have all been clinically validated and published and in previous trials on more than 31,000 positive prostate cancer samples as well as more than 100,000 control non-cancer samples.
A highly accurate prostate cancer test will provide significant benefits for seemingly well 45-70 year-old men and also for healthcare providers. The increased accuracy should reduce the requirement to run unnecessary MRI scans. The need for highly invasive digital rectal examinations (DRE) will also be dramatically reduced.
The new test is being developed at the Cambridge laboratory of EDX Medical Group which develops and supplies digitally enhanced diagnostic tools for cancer, cardiovascular and infectious diseases. The company has filed a patent application for the test and the AI algorithm with the European Patent Office.
Prof Sir Chris Evans, founder and chief scientific officer of EDX Medical, said: “We have been studying this area intensively and are tremendously excited by what we believe is a truly game-changing test. Every indication thus far shows it will be the most accurate and sensitive screening test available and will be transformative in tackling prostate cancer in men who may have no idea if anything is wrong with them.
“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. The incorporation of all these biomarkers into routine screening could revolutionise prostate cancer management by enabling earlier detection and more accurate risk prediction. What sets this test apart is the use of so many biomarkers with best-in-class instrument and reagent technology and our bespoke AI algorithm.”
EDX Medical’s scientific team will validate further clinical data over coming months prior to seeking regulatory approval from the Medicines & Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) with a view to launching the test later this year or early 2026.