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Oxford Biodynamics launches 94% accurate PSE test for Prostate Cancer

Oxford Biodynamics PLC is a global biotechnology company leading the world in the study and commercialisation of 3D genomics. The company is listed on the AIM market and has a market cap of £60m.

This week they released some very exciting news when they announced the launch of their 94% accurate PSE test for Prostate Cancer. CEO Jon Burrows and his team have been working overtime to get this test to the market and have managed to get the lab certification and all approvals completed in a very short time. Certainly, much sooner than originally hoped for when they announced plans to have the test on the market by the end of the year.

Despite his busy schedule I was able to sit down with the CEO Jon Burrows to hear him talk about what a game changer this is for the company and for men’s health.

The PSE test for prostate cancer was developed in collaboration with Imperial College London, Imperial College Healthcare NHS Trust and the University of East Anglia as part of the four-year Prostagram trial. The study results were peer reviewed in “Cancers”, an open access journal of oncology, and published in February 2023. The task set within the Prostagram trial was to improve the results of the unreliable PSA test which is why the PSE test will be used alongside the PSA test. Together, the PSA level combined with 5 epigenetic markers in the PSE test provide significantly better results and consequently offer so much value to patients and the healthcare system.

OBD’s PSE Test for prostate cancer was found to have Positive Predictive Value of 0.93, a Negative Predictive Value of 0.95 and an overall accuracy rate of 94%. These results are substantially better than the existing widely used PSA test which has a Positive Predictive Value of only 0.25 , a Negative Predictive Value of 0.86 and an overall accuracy rate of 55%. This is a huge difference and in practice this means that for those taking the PSA and getting a positive result, for 75% of them the diagnosis is incorrect. These incorrect diagnoses cause a huge amount of angst and worry for patients as well as leading to unnecessary MRI scans and costly biopsies, often with unpleasant side effects. The consequences of an unnecessary biopsy are actually quite shocking: 40% of men experience a complication; 9.1% of men have to visit a hospital emergency department and 8-33% of men suffer erectile dysfunction to mention just three of the issues. The 94% accurate PSE test from OBD saves men and their families from this worry and will provide significant savings to the overall healthcare system.

The test is available to order immediately in both the US and the UK although for the time being the PSE analysis will be carried out in a CLIA-certified lab in the US. A digital D2C marketing campaign has been launched targeting both patients and doctors. One of the big differences between the US and the UK healthcare market is that in the US there is a lot of self-advocacy from patients about their treatment. Following an elevated PSA test result, it is expected that many patients will carry out research into the implications and the treatments and this will lead them to the advantages of the PSE test to make sure of the diagnosis. They will likely end up at the PSE website which provides more information on the test and how it can be ordered. They will then request their doctor orders one for them and either will pay for it themselves or have it added to their medical insurance cover.

In the US market it is expected that both self-paying patients and those with medical insurance will use the test. Whilst the test has been launched without a unique CPT/PLA code, the company know from their CiRT experience that having a unique insurance code in place enables faster and higher reimbursement rates. It is expected that the cost of the PSE test for self-pay concierge patients will be $950.

In the UK the test is available through private medical practices and will cost £750. Given the significant benefits the test provides it is hoped that the NHS will be able to fast track approval for the PSE test to be incorporated into a National Screening program – something that has been called for by health professionals and advocacy groups for a long time.

In terms of market potential, there are 25m PSA tests conducted in the US every year and 1million men are sent forward for intrusive follow up work. That’s a huge number of expensive MRI scans and biopsies, with 75% of them completely unnecessary. In addition there are 11m men in the UK aged between 50 and 80 who need a PSE test and many more millions across the globe.

If OBD are able to achieve only a 1% market share that would equate to 250,000 tests a year which doesn’t sound unreasonable given the market knows that the current PSA test is unreliable and not fit for purpose. In fact, the market is desperate for a better test. The huge amount of incoming interest received from physicians and hospitals since the publication of the Prostagram trial in February is evidence of this interest.

Their current lab facility in Frederick, Maryland has the capacity to process 200,000 tests a year. This capacity could be tripled to 600k tests a year with further investment estimated at $1.5m. The plan though, after launch and adoption, is to partner with the leading healthcare laboratory testing companies and use their existing laboratory testing facilities and distribution networks to achieve a much larger market share.

So, the launch of the PSE test is a significant step on their commercialising journey. It is likely to enhance their cancer franchise and should boost sales of their existing Checkpoint Inhibitor Response Test. The Episwitch platform has also developed a pipeline of blood tests moving towards commercialisation. One of the closest to market is a diagnostic screening test for early detection of Colorectal cancer and this has the potential to be just as large as the market for the PSE test.

These are exciting times for OBD and promising times for patients across the globe.

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