
Oxford BioDynamics Launches EpiSwitch Prostate Screening Blood Test in the US
Oxford BioDynamics, a biotechnology company at the forefront of precision medicine, has introduced its EpiSwitch Prostate Screening (PSE) blood test to men at risk of prostate cancer in the United States. This innovative test, designed to work alongside the standard PSA test, boasts an impressive accuracy rate of 94%, significantly outperforming the PSA test’s 55% accuracy rate.
Prostate cancer is a widespread concern, and early detection is crucial for successful treatment. The EpiSwitch PSE test, which can be administered to men undergoing prostate cancer screening, whether due to elevated PSA levels or the need to rule out cancer, provides a reliable way to assess the presence or absence of prostate cancer.
Dr. Phillip Pierorazio, Section Chief of Urology at Penn Presbyterian Medical Center, praised the new test, saying, “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.”
The EpiSwitch PSE test uses 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.
The current PSA test, with its relatively low accuracy, often leads to dilemmas for patients and doctors alike. After an elevated PSA result, individuals face the prospect of retesting with an unreliable test, undergoing a potentially unnecessary invasive biopsy (with an accuracy rate of 88%), or opting for an MRI scan (with an accuracy rate of 49%). In the United States, nearly one million patients undergo prostate biopsies each year, and only a fraction of those with elevated PSA levels are found to have prostate cancer. Biopsies come with their own set of risks, including erectile dysfunction, urinary tract infections, rectal bleeding, extended hospitalization, and even rare cases of death due to complications or infections.
The EpiSwitch PSE test addresses these challenges by combining the PSA score with five epigenetic biomarkers to predict prostate cancer presence or absence. Patients with a low likelihood of cancer can be monitored through active surveillance, eliminating the need for an invasive biopsy. Conversely, patients with a high likelihood of cancer will receive referrals to urologists for further treatment.