VolitionRX Limited has announced that its single NuQ biomarker assay detected 71% of early stage I prostate cancer cases at 93% specificity, which is claimed to be significantly higher than the most common blood test currently used to detect prostate cancer.
The common blood test is called Prostate Specific Antigen (PSA), and is reported to detect 53% of prostate cancers at 73% specificity.
Nearly three million men are estimated to be living with prostate cancer in the US.
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, only a small percentage of men experience more rapidly growing, aggressive forms of prostate cancer.
The United States Preventative Services Task Force (USPSTF) has recommended against PSA based screening for healthy men in 2012 and called for research to identify new screening methods.
However, 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.
Similar to VolitionRx’s NuQ biomarker assays, the PSA test needs a small amount of blood and uses a common screening platform, known as ELISA. However, sensitivity and specificity of the PSA test are less than optimal.
VolitionRx has conducted a retrospective study on blood samples collected from 537 men, including 266 with prostate cancer and 271 age-matched healthy controls.
These 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 with 7% false negatives.
University of Surrey urological oncology professor and Surrey Cancer Research Institute director Prof. Hardev Pandha 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 CEO Cameron Reynolds said: "VolitionRx’s NuQ biomarker assay uses the same ELISA platform as PSA that is ubiquitous in healthcare laboratories worldwide and is a similarly low-cost, non-invasive test and also requires very little blood.
"Over the coming months, we will conduct further clinical studies on this NuQ biomarker assay, in parallel with pursuing CE marking.
"With the highly-encouraging results from this study, we are currently aiming for VolitionRx to launch a prostate cancer test for clinical use in Europe in 2017 and start US trials following the commercial launch of our blood test for colorectal cancer towards the end of this year."