
Oxford BioDynamics Receives New PLA Code for EpiSwitch PSE Prostate Cancer Test
Oxford BioDynamics, a company specializing in precision medicine tests, announced that the American Medical Association’s CPT (Current Procedural Terminology) Editorial Board has assigned a Proprietary Laboratory Analysis Code (PLA Code) specifically for the EpiSwitch® Prostate Screening (PSE) test developed by Oxford BioDynamics. The assigned code, 0433U, is unique and has been designated for the EpiSwitch® Prostate Screening test. It is set to go into effect from January 1, 2024 under the new Clinical Laboratory Fee Schedule.
Oxford BioDynamics just recently launched its EpiSwitch PSE test in September. The EpiSwitch PSE test uses five epigenetic markers and evaluates circulating chromosome conformation signatures in the loci encoding for of DAPK1, HSD3B2, SRD5A3, MMP1, and miRNA98 associated with high-risk prostate cancer. In the PROSTAGRAM screening pilot study which looked at 109 blood samples from men with and without prostate cancer, when these markers were combine with PSA as a continuous variable, the test had a positive predicitive value of 0.92 and a negative predictive value of 0.94. This translates to specificity of 97% (compared to PSA’s 53%) and sensitivity of 86% (compared to PSA’s 64%). The inaccuracy of PSA testing led the United States Preventive Service Task Force (USPTF) to recommend against prostate cancer screening using PSA in men over 70 and to discuss screening benefits and risks with their physicians for men 55-69.
Thomas Guiel, OBD’s Chief Operating Officer, emphasized the significance of the unique code, stating, “A unique code is critical to the reimbursement process. With the code issued at this early stage of the test introduction, we are in a good place to drive adoption of this highly accurate test.”