VolitionRx’s Nu.Q cancer-screening blood tests could replace colonoscopies, biopsies

• VolitionRx has designed a routine blood test called Nu.Q to screen for colorectal and prostate cancers
• Belgium-based company hopes to replace expensive and invasive procedures like colonoscopies and biopsies
• NYSE-listed company eyeing the test for ovarian disease endometriosis and cancer detection in dogs

VolitionRx (NYSEAMERICAN:VNRX) is a multi-national life sciences company that develops easy-to-use blood-based cancer tests to accurately diagnose a range of cancers. It was founded in 2010 by Cameron Reynolds, who is its CEO.  

The diagnostic tests are based on the science of nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid to get an indication that a disease is present.

The NYSE-listed company has designed a routine blood test called Nu.Q to screen for colorectal and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. It might also work as a screening tool for endometriosis and has potential veterinary uses as well.

At Volition’s command and control center in Isnes, Belgium, more than 30 scientists are conducting the background work necessary to introduce Nu.Q blood tests to the public in Asia, Europe and the US.

At the center of it is Volition’s NuQ platform, which looks for molecular signatures of cancer by focusing on the nucleosomes – a section of DNA wrapped around a core of proteins – in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes, which are analyzed by Nu.Q’s platform.

The company has already tested Nu.Q to detect prostate cancer. In August 2018 Volition announced preliminary data from an 84-patient study that showed its Nu.Q test kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Inflection Points

Prostate cancer aside, Volition is executing a pact, through its wholly-owned subsidiary, Belgian Volition SPRL, to conduct its first large-scale lung cancer study with the National Taiwan University. The company expects to release preliminary data relating to the first 600 patient samples in the first quarter of 2020.

But the management team at Volition is also charging ahead in running trials for colorectal cancer at the same time.

In the US, Volition is taking part in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research Network.

Data is being collected from over 13,500 people in the US, a project that is set to be completed in 2020. 

The collection of a European study involving the evaluation of 4,500 people with 27 of the most prevalent cancers at the University of Bonn in Germany, has also finished.

And in 2018, Volition signed agreements with National Taiwan University to conduct two large-scale colorectal studies across Asia. The company expects to finish them in Asia in 2020 and in the US in early 2021.

The prospect of a routine blood test that can replace expensive and invasive procedures like colonoscopies and biopsies is drawing substantial investor interest, including from European government agencies as well as the Walloon Regional government, which oversees the French-speaking region of southern Belgium where the company’s Research & Development facility is based.

The company has also entered into a sales and distribution partnership with another life sciences group, Active Motif, that has paved the way for a sale of research-only kits based on its Nucleosomics technology.

Volition is aiming to partner with European governments to introduce triage tests, which would rely on Nu.Q tests to weed out people who are less likely to have colon cancer.

The first Nu.Q tests to detect colorectal cancer are likely to hit Europe by the end of next year, followed by Asia in 2020 and the US by 2021. Reynolds said the company won’t see “serious” revenue until 2021 or 2022.

But the company is also migrating far beyond its primary line of work in cancer detection. In its sights are the painful ovarian disease endometriosis, where it is collaborating with the University of Oxford to see whether Nu.Q blood-based tests can be used for diagnosis.

It’s also pushing into veterinary medicine and pursuing a tie-up with Texas A&M’s College of Veterinary Medicine & Biomedical Science after discovering that nucleosomes in the blood can also be detected in dogs.

Outlook

In May, Volition announced that it ended its first quarter with $16.2 million in cash and cash equivalents, up from $13.4 million at the end of 2018.

In addition, the company said it continues to manage its cash carefully with a cash burn of $3.9 million in the first quarter, which ended March 31.

“During the first quarter 2019, we further strengthened our balance sheet with existing investors exercising $6.7 million in aggregate amount of outstanding warrants to purchase shares of our common stock,” Reynolds said.

He added that “subsequent to the ending of the quarter, a further $5 million in warrants were exercised for cash, making a total of $11.7 million in warrants exercised this year.”

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Story by ProactiveInvestors