Oxford BioDynamics (OBD) has launched its EpiSwitch Prostate Screening (PSE) blood test in the US and UK. The test, which has been validated in OBD's US clinical laboratory, is designed to run alongside the standard PSA test and boosts the predictive accuracy for determining the presence or absence of prostate cancer from 55% to 94%. The increased accuracy of the PSE test significantly reduces false positives, leading to a decrease in unnecessary referrals for invasive biopsies. The PSE test combines the PSA score with five proprietary epigenetic biomarkers to predict the presence or absence of prostate cancer with 94% accuracy. It has high specificity of 97% and sensitivity of 86%, along with high positive and negative predictive values. The test has been validated as a laboratory developed test in OBD's CLIA-certified testing laboratory in Maryland.
The PSE test is the result of a collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust, and leading prostate cancer experts. The test has been validated in a clinical trial and the results were published in the peer-reviewed publication Cancers. The PSE test provides an alternative to the PSA test, which is considered unreliable by many doctors. The PSA test has a low accuracy rate and often leads to a dilemma for patients who receive an elevated PSA level, as they must decide whether to retest with PSA or undergo more invasive screening methods such as a prostate biopsy.
The launch of the PSE test coincides with Prostate Cancer Awareness month and aims to provide men being screened for prostate cancer with a highly accurate and reliable test. The PSE test can help reduce unnecessary anxiety and expense by reducing false-positive results and avoiding unnecessary referrals for invasive biopsies. The test can be used for men with all PSA values, as not all high PSA values will return a high likelihood result and some low PSA values will. Patients can speak to their doctor about ordering the PSE test, and test results will be returned to the ordering physician within five days after the blood sample is received in the laboratory.