National University Hospital Singapore and X-ZELL agree on landmark cancer detection study
According to the document, the study will focus specifically on patients with a diagnostically ambivalent PSA score between 4-20ng/mL – commonly referred to as the “diagnostic grey zone” (more here) – and a previous suspicion of the disease.
To compare the performance of X-ZELL Prostate™ to existing diagnostic tools, all patients are set to undergo a standard, random prostate biopsy, and in selected cases a super-saturated prostate biopsy. Blood samples from all patients included will also take a reference blood test, such as the FDA-approved Prostate Health Index (PHI) test.
The results of all biopsies and reference tests will remain classified until all testing has been concluded and all X-ZELL results have been reported.
According to NUH and X-ZELL, the intention of the study is to determine the suitability of X-ZELL Prostate™ as a non-invasive method to detect clinically significant prostate cancer early – especially in cases where ambiguous PSA readings could otherwise lead to unnecessary tissue biopsies.
“A successful study would therefore validate the clinical utility of X-ZELL Prostate™ as a non-invasive, pain-free early detection tool and pave the way for the test’s commercial rollout in the ASEAN region,” the LOI confirmed.
The study is planned to take two years and will include about 300 patients to ensure a statistically significant result. A specific start date is yet to be confirmed.
About X-ZELL Prostate™
X-ZELL Prostate™ is a liquid biopsy test using tumor-derived circulating cells, including tumor-derived Circulating Endothelial Cells (CEC), as biomarkers to indicate the presence/ absence of clinically significant prostate cancer in small, 8-10mL blood samples. Click here to find out more.