EDX Medical has developed a new non-invasive prostate cancer test it hopes will transform diagnosis and detection of the disease.
The purpose of the Cambridge, UK-based company’s test is to identify the presence or absence of cancerous cells, signs of early and late-stage cancer, whether disease progression is slow or aggressive, and what the genetic or hereditary risks for a patient may be.
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According to Cancer Research UK, there is an incidence of around 55,000 new cases of prostate cancer in the country each year.
Dubbed a ‘super test’ by EDX, the test measures 100 clinically validated prostate cancer biomarkers, the most currently known, as per the company, in both blood and urine samples. Currently available advanced prostate cancer tests typically rely on up to 20 biomarkers per test.
Once gathered, the biomarkers are analysed by a bespoke artificial intelligence (AI)-powered algorithm to generate result reports for doctors.
The test also takes a ‘multi-omics’ approach, comprising a combination of multiple proteomic, transcriptomic, genetic/hereditary, and epigenetic biomarker signatures, with a list of phenotypic and symptom data added to the biomarker data and simultaneously analysed by the AI algorithm.
According to EDX, the test will reduce the requirement to run unnecessary MRI scans and the need for highly invasive digital rectal examinations (DRE) of patients.
The company forecasts that it will be capable of delivering an accuracy between 96-99% across a broad age-range and diverse ethnic groups. Research indicates that current standard of care (SoC) for prostate cancer testing, including prostate specific antigen (PSA) tests and biopsies, can be below 50% and with false-positives possible.
EDX founder and chief scientific officer Chris Evans said: “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.”
EDX has filed a patent application for the test and the AI algorithm with the European Patent Office (EPO) and plans to further validate the test’s clinical data over the coming months.
Following further validation, the company stated it will pursue regulatory approval for the test from the Medicines & Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), with plans to launch the test later this year or in early 2026.
