National University Hospital Singapore and X-ZELL sign LOI
Singapore, June 2018 – The Department of Urology at Singapore’s National University Hospital and X-ZELL have signed a Letter of Intent (LOI) to jointly conduct a prospective, blinded study evaluating the utility of X-ZELL Prostate™ for early prostate cancer detection.
X-ZELL Prostate™ is a blood test using circulating atypical cells, including tumour-associated Circulating Endothelial Cells (tCEC), as biomarkers to indicate the presence or absence of clinically significant prostate cancer in small, 8-10mL blood samples.
According to the LOI, 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” – 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.
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