VolitionRx unveils data showing its Nu.Q assays detect aggressive prostate cancer in men with 94% accuracy

Life sciences company VolitionRx Ltd (NYSEAMERICAN:VNRX), which is focused on developing blood-based diagnostic tests for different cancers, announced preliminary data Monday from a study that showed its Nu.Q assay kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Shares of VolitionRx shot up 14.2% to US$1.93 on the news.

The multi-center study collected blood samples from 84 men referred for prostate biopsies to three Belgian hospitals. The men were grouped by biopsy findings as having no cancer (most of whom had elevated prostate-specific antigen (PSA) levels), low-grade cancer or high-grade cancer. The samples were tested with a panel of five assays (the standard PSA blood test, two Nu.Q assays and two inflammatory biomarkers).

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The Volition panel of five assays, including the standard PSA test, identified 94% of aggressive cancers that required treatment.

VolitionRx’s Nu.Q assay compared favorably with just 33% identified by the PSA test alone, which relies on detection through high levels of prostate-specific antigen that may indicate the presence of prostate cancer.

“This is a very exciting outcome for us as we continue the development of our assays beyond colorectal cancer. The preliminary data from this study showed that Volition’s panel of assays identified men with potentially lethal high-grade prostate cancer with much greater accuracy than PSA alone,” said Jake Micallef, chief scientific officer at VolitionRx.

“Based on this data, we believe that this test could assist clinicians in more accurate patient selection for prostate biopsy and treatment and substantially reduce the amount of unnecessary procedures in men with low-grade tumors or no tumor. The next step is to confirm these statistically significant findings in independent larger clinical trials,” he added.

Prostate cancer is the second-leading cause of cancer death in men in the US after lung cancer.

Currently, prostate cancer is diagnosed through medical history, physical examination and by elevated levels of PSA in the blood. Men suspected of PCA are given a prostate biopsy to confirm the presence of cancer. However, most men with elevated PSA levels referred for prostate biopsy either have no cancer or have low-grade cancer which needs monitoring but not treatment.

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VolitionRx’s study suggests the Nu.Q assays may provide better risk stratification than that available using PSA tests for men with actual or suspected PCA, leading to better patient management and fewer unnecessary biopsies.

“A non-invasive test to help in the risk stratification of men with suspected or actual prostate cancer will be a major step forward in the management of this disease. The correlation of the panel blood test results with Gleason Score shows great promise in this regard. We will further investigate the data in relation to disease stage as well as additional factors used for pre-treatment risk stratification,” said principal investigator, Professor Thierry Roumeguere, head of urological services, in the Erasme Hospital, in Brussels, Belgium.  

VolitionRx CEO Cameron Reynolds said the small trial is “important” because it “helps demonstrate once more the potential breadth” of the company’s technology.

“If these results are validated in larger trials, they will present a potentially significant new market opportunity. Volition’s research team is continuing to develop our Nu.Q assays and we aim to launch products in 2019,” said Reynolds.

Gaetan Michel, CEO of Volition’s wholly-owned subsidiary, Belgian Volition SPRL, said the study was generously funded by the government of the Walloon Region.

VolitionRx develops and markets cost-effective, easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx‘s Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

The NU.Q Assay kits being sold by VolitionRx for colorectal cancer detection are the first of a planned series of kits being rolled out in the coming months. The Nu.Q holds promise and is being evaluated in Asia, the European Union and the US. The first data readouts and commercial launches are expected this year and into 2020.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors