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Real-world study demonstrates next-gen EpiSwitch PSE blood test safely reduces unnecessary biopsies by up to 79% while accurately detecting prostate cancer.

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A real-world study published high-impact journal Cancers demonstrates the transformative potential of a next-generation prostate cancer blood test developed in the UK to accurately detect more cases of early prostate cancer, while potentially drastically reducing the cost needed to implement a UK-wide screening program.

Prostate cancer is the most common cancer among men in the UK, yet there is no national screening program due to traditional testing relying on an initial prostate-specific antigen (PSA) test, which is not an accurate indicator of prostate cancer by itself.

Approximately 3 in 4 men with a high PSA level do not have cancer, according to Prostate Cancer Research. As a result, many healthy men undergo unnecessary medical scans, invasive procedures, and, in some cases, even overtreatment, leading to  significant anxiety and burden for patients, while also straining healthcare resources.

Dr. Garrett Pohlman, MD, Urologist at Kearney Urology Center and lead author of the study said: “The results we have seen by integrating EpiSwitch PSE have been transformative. These findings show that a routine blood test can enable us to safely avoid biopsies in up to a staggering 79% of patients with an elevated PSA without compromising diagnosis. This is a major advancement that helps our patients benefit from reduced anxiety and the avoidance of unnecessary, costly medical procedures.”

By integrating EpiSwitch PSE into clinical practice, the healthcare system could achieve significant savings. The study found that among 187 patients, the PSE test potentially avoided 97 unnecessary prostate biopsies and 95 MRIs in this group alone.

This translates into an estimated cost saving of over 170,000 GBP (230,000 USD), or almost 1,000 GBP per patient, accounting for reduced subsequent procedures, MRI scans, and occasional downstream complications due to risks from prostate biopsies. Fewer MRI scans also reduce the need for substantial government investment in additional imaging infrastructure.

When expanded to the national level, the health-economic impact of incorporating PSE into a screening workflow could be substantial according to the study. In the US, the authors estimates that PSE has the potential to conservatively help avoid up to 593,000 prostate biopsies per year, with the economic benefit approaching 2 billion USD annually.

Oliver Kemp, MBE, Chief Executive Officer of UK charity Prostate Cancer Research, said: “This study shows how smarter testing can save millions while improving care for patients. Reducing unnecessary biopsies and scans means less stress for men and more capacity in the system.”

The innovation behind EpiSwitch PSE originates from a British company, Oxford BioDynamics (OBD), in collaboration with leading researchers and clinicians at the Imperial NHS Trust, Imperial College London, and the University of East Anglia.

Dr. Alexandre Akoulitchev, MA, PhD, FRSM, Chief Scientific Officer at Oxford BioDynamics, said: “This study builds on our earlier robust clinical validation work which demonstrated the application of EpiSwitch PSE as a precise, minimally invasive test that empowers clinicians and patients with clarity, reduced patient risk, and improved outcomes, while easing the pressure on the diagnostic pathway.”

Given these health and economic outcomes, Oxford BioDynamics says that EpiSwitch PSE is poised to ‘set a new standard’ and streamline prostate cancer diagnosis and management strategies in the US, where it is routinely reimbursed by Medicare, and the UK, where it is currently widely available to private patients and reimbursed by Bupa Health Insurance.

Related

Washington State University researchers have discovered how the bacteria that cause anaplasmosis and Lyme disease hijack cellular processes in ticks to ensure their survival and spread to new hosts, including humans.

Based in the College of Veterinary Medicine, the team found that the bacteria can manipulate a protein known as ATF6, which helps cells detect and respond to infection, to support its own growth and survival inside the tick. The findings, published in the journal Proceedings of the National Academy of Sciences, could serve as a launching point for developing methods to eliminate the bacteria in ticks before they are transmitted to humans and other animals.

Most research has looked at how these bacteria interact with humans and animals and not how they survive and spread in ticks. What we have found could open the door to targeting these pathogens in ticks, before they are ever a threat to people.”

Kaylee Vosbigian, doctoral student and lead author on the study

Vosbigian and her advisor, Dana Shaw, the corresponding author of the study and an associate professor in the Department of Veterinary Microbiology and Pathology, focused their research on Ixodes scapularis, also known as the blacklegged tick, which is responsible for spreading both Anaplasma phagocytophilum and Borrelia burgdorferi, the causative agents of anaplasmosis and Lyme disease. Both diseases are becoming increasingly common and can cause serious illness in humans and animals.

The team discovered that when ATF6 is activated in tick cells, it triggers the production of stomatin, a protein that helps move cholesterol through cells as part of a normal cellular processes. The bacteria exploit this process against their tick hosts, using the cholesterol –which they need to grow and build their own cell membranes but cannot produce themselves – to support their own survival and success.

“Stomatin plays a variety of roles in the cell, but one of its key functions is helping shuttle cholesterol to different areas,” Vosbigian said. “The bacteria take advantage of this, essentially stealing the cholesterol they need to survive.”

When the researchers blocked the production of stomatin, restricting the availability of cholesterol, bacterial growth is significantly reduced. The researchers believe this shows targeting the ATF6-stomatin pathway could lead to new methods for interrupting the disease cycle in ticks before transmission occurs.

As part of the study, Vosbigian also developed a new research tool called ArthroQuest, a free, web-based platform hosted by WSU that allows scientists to search the genomes of ticks, mosquitoes, lice, sand flies, mites, fleas and other arthropod vectors for transcription factor binding sites – genetic switches like ATF6 that control gene activity.

“There aren’t many tools out there for studying gene regulation in arthropods,” Vosbigian said. “Most are built for humans or model species like fruit flies, which are genetically very different from ticks.”

Using ArthroQuest, the team found that ATF6-regulated control of stomatin appears to be prevalent in blood-feeding arthropods. Since the hijacking of cholesterol and other lipids is common among arthropod-borne pathogens, the researchers suspect many may also exploit ATF6.

“We know many other vector-borne pathogens, like Borrelia burgdorferi and the malaria-causing parasite Plasmodium, rely on cholesterol and other lipids from their hosts,” Shaw said. “So, the fact that this ATF6-stomatin pathway exists in other arthropods could be relevant to a wide range of disease systems.”

The research was supported in part by a National Institutes of Health R01 grant and a College of Veterinary Medicine intramural seed grant.