UK-based biotechnology company Oxford BioDynamics has announced the clinical validation and commercialisation of its EpiSwitch Prostate Screening (PSE) blood test in the US.
Oxford BioDynamics developed the EpiSwitch Prostate Screening (PSE) test based on its unique EpiSwitch 3D genomics platform.
The test runs alongside a standard prostate-specific antigen (PSA) test and enhances its prostate cancer predictive accuracy from 55% to 94%.
EpiSwitch PSE test is immediately available to men with prostate cancer risk in the US, using a high-complexity CLIA-certified lab facility in Frederick, Maryland.
The test is being commercialised in the US as part of a programme to screen men for prostate cancer, either with an elevated PSA result or where prostate cancer must be ruled out.
University of Pennsylvania Hospital professor of surgery and Penn Presbyterian Medical Center urology section chief Phillip Pierorazio said: “Although the traditional PSA has demonstrated clinical utility in prostate cancer screening and monitoring, it also has limitations that are well-described.
“A more sensitive and specific test would have the potential to increase diagnostic accuracy and address some of the current challenges with prostate cancer screening.”
According to the company, the current PSA blood screening test provides only 55% accuracy and is considered unreliable by several doctors, including the NHS in the UK.
The EpiSwitch PSE not only offers 97% specificity and 86% sensitivity, but a high positive predictive value of 93% and negative predictive value of 95% for the risk of prostate cancer.
It combines the PSA score with five epigenetic biomarkers to predict the presence or absence of prostate cancer.
Patients with a PSE result showing a low risk of cancer can be placed on active surveillance and retested later without subjecting them to an invasive biopsy, said the company.
The EpiSwitch PSE test has been validated as a laboratory-developed test (LDT) in OBD’s CLIA-certified testing laboratory in Frederick, Maryland, US.
OBD chief executive officer Jon Burrows said: “There is a clear need in everyday clinical practice for a much more accurate blood test that can screen men for prostate cancer and accurately identify those at risk while sparing those who up to now would be subject to unnecessary, expensive, and invasive procedures.
“With the news today of the launch of another EpiSwitch-based product, we are continuing to improve patient health whilst also reducing the cost of care.”
