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.
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."
Sir Chris Hoy, who has been diagnosed with prostate cancer and supports campaigns to raise awareness and encourage early diagnosis, said: "Prof Sir Chris Evans and his team encouraged and supported me greatly after my initial diagnosis and I know they have some amazing people and a great commitment to finding better ways to diagnose and treat prostate and other cancers. I now know there is a need for better and more accurate prostate cancer screening tests and I wholeheartedly welcome this initiative by Sir Chris' EDX."
Rio Ferdinand, former Manchester United and England captain, whose mother and first wife Rebecca died of cancer, said: "Those of us who have lost a loved one to cancer and have campaigned for research and more awareness know full well the need for better and earlier testing across a range of cancers. Ethnic minority men not only have twice the risk of getting prostate cancer, they also have higher rates of stage 3 and 4 and more aggressive cancer. We know if it can be caught early these men can be mostly cured, but it's not, and too many men are dying unnecessarily. I believe a test as good as Sir Chris' EDX one can one day put a stop to this and I look forward to its launch later this year."
Andy Taylor, guitarist with Duran Duran who was diagnosed with prostate cancer at 55, said: "Prof Sir Chris helped me immensely with my cancer treatment and this revolutionary new test from his labs is simply brilliant. To know your prostate cancer status, stage and type and all your genetics when you were unaware there was a problem at all is a life saver and game-changer. It is so accurate and comprehensive, it can spot many early prostate cancers, save many lives and save a fortune in fruitless treatments: this is priceless."
Dr Mike Hudson, chief executive of EDX Medical said: "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."
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.
NOTES TO EDITORS
About multi-omics:
Multi-omics' combines genomic, transcriptomic and proteomic analyses plus information on additional gene expression products and clinical data to provide significantly enhanced information which can guide clinical decision-making.
About PSA testing
The vast majority of men rely on PSA tests as their first assessment of prostate cancer but elevated PSA is regarded as unreliable for definitive cancer diagnosis. Research has shown that ~70% of men with elevated PSA levels do not have cancer at all whereas around 20% of men who show normal or low PSA levels do have cancer and often an aggressive sub-type which is only discovered later when limited time remains for effective treatment..
About EDX Medical Group plc
The EDX Medical Group plc is listed on the Apex Segment of the AQSE Growth Market (TIDM: EDX). EDX Medical was founded by Professor Sir Christopher Evans, OBE, a medical and life sciences entrepreneur with more than 30 years of experience, together with CEO, Dr Mike Hudson.
By translating clinical insights into pragmatic solutions combining advanced biological and digital technologies, EDX Medical seeks to cost effectively improve the detection and characterisation of disease in order to personalise treatment in a timely fashion. Early disease detection and biologically-based personal treatment optimisation is considered to be the most impactful way of reducing deaths and lowering the cost of healthcare globally.
EDX Medical Group provides doctors, hospitals and insurers/payers with access to a portfolio of the best clinical diagnostics products and services. The Company operates its own facilities in Cambridge and Oxford, UK, and has a number of significant strategic with world leading companies and organisations in their respective fields.
www.edxmedical.com
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