Oxford BioDynamics Plc announces that validation of its EpiSwitch Prostate Screening (PSE) test in its US clinical (CLIA-certified) laboratory is now complete, ahead of schedule. Coinciding with Prostate Cancer Awareness month, OBD has brought forward the launch of its highly accurate, 94% precision medicine test to make it immediately available to men being screened for prostate cancer. This includes those who have received an elevated prostate-specific antigen (PSA) result as well as many others where prostate cancer is a clinical concern.

The current blood screening test, the PSA test, is only 55% accurate, and is considered an unreliable test by many doctors, including the NHS in the UK1. If results show an elevated PSA level, then patients face a dilemma - retest with PSA even with its low accuracy, or go for more invasive screening methods such as a prostate biopsy which has the potential for other health risks.1 Now there is an alternative. The PSE test is the culmination of nearly a decade's long collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust and UK's leading prostate cancer experts as part of the PROSTAGRAM screening pilot.

The results of this trial were published in the peer reviewed publication, Cancers2 in February this year. The PSE test is designed to run alongside a standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict, with 94% accuracy, the presence (or absence) of prostate cancer.2 Those with a PSE result of low likelihood of cancer can be placed on active surveillance and retested later without being referred for an invasive and often destructive biopsy. A high likelihood result would necessitate referral to a Urologist for further investigation.

As well as very high accuracy, PSE has high specificity of 97% (PSA: 53%) and sensitivity of 86% (PSA: 64%), along with both high positive, 93% (PSA: 25%), and high negative, 95% (PSA: 86%), predictive values to assess the risk of prostate cancer in men.2 It has been validated as a laboratory developed test (LDT) in OBD's CLIA-certified testing laboratory in Frederick, Maryland.