EpiSwitch Prostate Screening blood test launches on US market

The EpiSwitch Prostate Screening (PSE) blood test has been clinically validated and is now available to men in the US who are being screened for prostate cancer, announced Oxford BioDynamics, the developer of the test, in a news release.¹

"It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month," says Jon Burrows, PhD.

The blood-based test was validated as a laboratory-developed test in a centralized high-complexity Clinical Laboratory Improvement Amendments-certified laboratory in Frederick, Maryland.

“There is a clear need in everyday clinical practice for a much more accurate blood test that can screen men for prostate cancer and accurately identify those at risk, while sparing those who up to now would be subject to unnecessary, expensive, and invasive procedures. It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month," said Chief Executive Officer of Oxford BioDynamics Jon Burrows, PhD, in the news release.¹ “With the news today of the launch of another EpiSwitch-based product, we are continuing to improve patient health whilst also reducing the cost of care."

According to Oxford BioDynamics, the epigenetic test is designed to be used alongside a standard prostate-specific antigen (PSA) test. The blood-based test works by combining PSA score with 5 epigenetic biomarkers (DAPK1, HSD3B2, SRD5A3, MMP1, and miRNA98). In a recent study of the PSE test,² the tool was shown to improve the predictive accuracy of a standard PSA test from 55% to 94%.

“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,” said Phillip M. Pierorazio, MD, in the news release.¹ Pierorazio is the section chief of urology at Penn Presbyterian Medical Center and a professor of surgery at the Hospital of University of Pennsylvania.

In total, the retrospective study² included blood samples from 109 men aged 50 to 69 years who were enrolled in the PROSAGRAM screening pilot study and 39 patients from the Imperial College NHS Trust who had an established diagnosis of prostate cancer or were confirmed cancer-negative controls.

The PSE test was shown to have a specificity of 97% and sensitivity of 86%, compared with 53% and 64% for standard PSA alone, respectively. Further, the PSE test demonstrated a positive predictive value of 93%, compared with PSA’s 25%, and a negative predictive value of 95%, compared with PSA’s 86%.

Clinicians treating patients with prostate cancer can obtain the PSE test by completing a requisition form through the company’s ordering system. Patients can expect results 5 days after a blood sample is received.

References

1. Oxford Biodynamics announces US launch of its 94% accurate EpiSwitch Prostate Screening blood test to men with prostate cancer risk. News release. Oxford BioDynamics. Published online and accessed September 26, 2023. https://www.businesswire.com/news/home/20230926908052/en/Oxford-Biodynamics-Announces-US-Launch-of-its-94-Accurate-EpiSwitch%C2%AE-Prostate-Screening-Blood-Test-to-Men-With-Prostate-Cancer-Risk

2. Pchejetski D, Hunter E, Dezfouli M, et al. Circulating chromosome conformation signatures significantly enhance PSA positive predicting value and overall accuracy for prostate cancer detection. Cancers (Basel). 2023;15(3):821. doi: 10.3390/cancers15030821