Oxford Biodynamics PLC has announced the opening of a clinical testing facility in the UK to perform the EpiSwitch Prostate Screening (PSE) blood test. The facility, which is an ISO15189 clinical laboratory, has completed the clinical validation of the PSE test, enabling immediate application. This move expands the company's testing capacity and significantly shortens the turnaround time for tests ordered in the UK. The PSE test combines the PSA score with five proprietary epigenetic biomarkers to predict the presence of prostate cancer with 94% accuracy. The test is designed to provide a high accuracy second opinion for men receiving an accelerating or elevated PSA score.
The launch of the precision medicine testing in the UK will cut in half the turnaround time for any PSE tests ordered by UK physicians. The test has been available in the UK since September 2023, but until now, all samples were sent to OBD's US CLIA-certified lab for analysis and reporting prior to the opening of this UK-based clinical facility. The commissioning of the new clinical lab and the validation of PSE testing within that laboratory is an important milestone for the company, according to Thomas Guiel, Chief Operating Officer. The immediate benefit for clients in the UK will be the significant reduction in the elapsed time from receipt of an order to result, which will now be 5 days or less.
The PSE test is designed to be run alongside a standard PSA test to boost PSA's low sensitivity and low positive predictive value. Patients can speak to their doctor about ordering the PSE test, and the test results will be returned to the ordering physician within five days after the blood sample is received in the laboratory. Additionally, OBD will soon begin validating its other marketed precision medicine clinical test, the EpiSwitch Checkpoint Inhibitor Response Test (CiRT), within this new UK facility. The validation of CiRT will be completed over the coming months, which will be an important advance for OBD's partners and customers in the UK, including its strategic partner, Bupa UK.
Oxford BioDynamics Plc is a global biotechnology company that is advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases. Its flagship products are the EpiSwitch CiRT and EpiSwitch PSE blood tests. CiRT is a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, while PSE is a blood test that boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer.