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Scientists comment on a press release from EDX that gives findings on a new screening test for prostate cancer.
Prof Veeru Kasivisvanathan, Associate Professor of Urology, University College London, said:
“Any test that can improve the ability to identify clinically important prostate cancers would be a welcome addition. The EDx test is an interesting concept, combining information from a number of different sources including genetic information and using AI. However, its performance would need to be compared to our existing options such as PSA before any claims can be confidently made of it being a “super” test. It is important to understand whether the samples that the test have been validated in are from an appropriately diverse group of patients and how it performs in the real world compared to PSA. In addition, patients with an abnormal EDx result would currently still need to undergo MRI and biopsy to confirm the presence of cancer and plan treatments. There are of course important questions on access, practicality and costs of the EDx test that need to be evaluated.”
Prof Derek Rosario, Consultant Urological Surgeon, Honorary Professor and Clinical Advisor (Prostate) to the UK National Screening Committee, said:
“As far as I can tell from the information in the press release from EDX Medical, there have been no prospective clinical studies of this ‘super test’. The test relies on an algorithm to combine information from around 100 previously ‘validated’ biomarkers in blood and urine. To what extent these biomarkers are feeding in additional information and how the algorithm will work in clinical practice has yet to be determined. The most telling statement to me is … “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%.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.” So, there is an expectation that this test will be effective, but as far as I can tell these claims have not been demonstrated with a clinical study as yet. The test needs to be prospectively validated – I’m not sure whether I have missed the original literature on this, but we need more information than is currently provided by the press release to be able to validate the claims. To what extent this test will outperform something like the Stockholm 3 (a blood test that estimates the risk of prostate cancer in men) remains to be seen. A test that has both a sensitivity and specificity of 96-99% would be truly unusual in clinical practice – usually there is a trade-off to be had between the two, so that statistic does not quite make sense to me, though I would need to see the data underlying these claims to make a final judgement, but it is not yet provided.”
Professor Ros Eeles, Professor of Oncogenetics at The Institute of Cancer Research, London, and Consultant in Clinical Oncology and Cancer Genetics at The Royal Marsden NHS Foundation Trust, said:
“The development of new biomarker tests for early detection of prostate cancer is an important area of research to increase the number of prostate cancer cases found at an earlier stage and to prevent deaths from prostate cancer.
“However, it is very important to show that any new biomarker tests do indeed improve earlier diagnosis and such tests need trials to determine this. While the biomarkers used in this test have been validated, this particular combination of markers has not yet been shown to detect cancer at an earlier stage and prevent deaths.
“The TRANSFORM trial – led by six researchers including myself – will assess several approaches to earlier detection of prostate cancer in hundreds of thousands of men, including genetic risk stratification, imaging techniques and biomarkers.”
Prof Freddie Hamdy, Nuffield Professor of Surgery, Professor of Urology, University of Oxford, said:
“The fact that there is nothing published on the test does not necessarily mean they have not validated it already. They claim: “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.” So we have to assume that they have already done this, we just don’t know the data and the nature of the cohorts on which the test was validated, and we don’t know if it has been peer-reviewed and I tried to find published literature but couldn’t. They also admit the test needs further validation.
“They claim both high sensitivity/specificity AND accurate risk prediction. But increasing the diagnosis of prostate cancer in itself is not a desirable achievement unless it detects ‘important’ disease, i.e. clinically significant, and this is where the problem lies. How did they define ‘risk prediction’? Urologists themselves are revisiting what ‘clinical significant’ prostate cancer means. So for example if the ‘bar’ was the detection of any cancer with Gleason Grade Group 2 as the threshold, it is fraught with problems because it will continue to increase over-diagnosis and over-treatment.”
Press release: https://edxmedical.co.uk/product/a-new-comprehensive-prostate-cancer-screening-test/
Declared interests
Prof Veeru Kasivisvanathan: No conflicts.
For all other experts, no reply to our request for DOIs was received.