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VolitionRx announces study results showing NuQ® blood test detects prostate cancer early with significantly higher accuracy than PSA test

VolitionRx Limited has announced that a single NuQ® biomarker assay detected 71% of early stage I prostate cancer cases at 93% specificity. This is significantly higher than the most common blood test currently used to detect prostate cancer, the Prostate Specific Antigen (PSA), which is reported to detect 53% of prostate cancers at 73% specificity1. The study was conducted in collaboration with the Surrey Cancer Research Institute at the University of Surrey in the UK. The results are being presented at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA.

Approximately 14% of men will be diagnosed with prostate cancer at some point during their lifetime and nearly 3 million men are estimated to be living with prostate cancer in the United States alone2. While more than 80% of all prostate cancers are detected at the local stage, and nearly 100% of men diagnosed and treated at this stage will be disease-free after five years, a small percentage of men experience more rapidly growing, aggressive forms of prostate cancer3.

Since 2012, the United States Preventative Services Task Force (USPSTF) has recommended against PSA based screening for healthy men and called for research to identify new screening methods4. Nonetheless, the PSA test is commonly used for patient monitoring and other purposes because it is a low-cost, non-invasive test that is easy to use for the patient. Like VolitionRx’s NuQ® biomarker assays, the PSA test requires a small amount of blood and uses a common screening platform, known as ELISA, that is ubiquitous in healthcare laboratories worldwide. However, sensitivity and specificity of the PSA test remains less than optimal.

VolitionRx has performed a retrospective study on blood samples collected from 537 men, including 266 with prostate cancer and 271 age-matched healthy controls. The samples were analysed with a single NuQ® biomarker assay, which detected 71% of early stage I prostate cancer cases and 86% of late stage IV prostate cancer at 93% specificity (7% false negatives). Details of the data presented at AACR can be found at http://ow.ly/4mRRRm.

Prof. Hardev Pandha, Director of the Surrey Cancer Research Institute and Professor of Urological Oncology at the University of Surrey, said, “This NuQ® biomarker study has shown very encouraging results in this patient cohort. Further studies are needed but the test may potentially have uses in detecting and monitoring men with prostate cancer.”

VolitionRx Chief Scientific Officer, Dr. Jake Micallef, commented, “This single NuQ® biomarker assay has shown great potential for high accuracy in detecting early stage I prostate cancer. The ability to detect early stage prostate cancer at significantly greater sensitivity than the PSA test with a simple ELISA blood test is a remarkable breakthrough. The accuracy of this single NuQ® test may be further improved by use of a combination of NuQ® tests in a panel with PSA and this, plus the usefulness of the test for monitoring treatment, will be a focus of future studies by our team. The achievement of high accuracy with a single assay, rather than a panel of assays, is the result of the increasing insight of VolitionRx in predicting and identifying NuQ® markers for the detection of specific cancers with high sensitivity and with very few false positives.”