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

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

What VolutionRx does:

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 fluids 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. VolitionRx is also developing the technology as a screening tool for endometriosis and for veterinary uses as well.

At VolitionRx’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 this work is the 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 the Nu.Q platform.

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

How is it doing:

Prostate cancer aside, VolitionRx 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.

The company has also launched a second lung cancer study, partnering with China-based Shanghai Fosun Long March Medical Science Co Ltd, a manufacturer of diagnostic and laboratory instruments. The study will use Volition’s Nu.Q assays to screen for lung cancer at Fosun’s hospitals, research institutions and clinics. 

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

In the US, VolitionRx 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 finished.

And in 2018, VolitionRx 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.

VolitionRx 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.

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 is also pushing into veterinary medicine and has 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. The company and the university are currently studying a version of its blood-based tests for animals called Nu.Q Vet, which was highlighted recently at the Veterinary Cancer Society’s annual conference in Houston.

While the company expands into animal health, it has launched a new Texas-based subsidiary called Volition Veterinary Diagnostics Development LLC, tapping animal-health expert Nathan Dewsbury to spearhead it.

As for VolitionRx’s finances, the company ended its second quarter on June 30 with $18.5 million in cash and cash equivalents, up from $13.4 million at the end of 2018. And the company continues to manage its cash carefully with a cash burn of $2.9 million in the second quarter.  

So far in 2019, more than $16 million in warrants have been exercised by investors. In addition, the company over the summer secured $1.4 million in non-dilutive funding in the form of a non-repayable cash grant from the Walloon Region in southern Belgium. To date, agencies from Walloon have awarded the company nearly $6 million in funding. 

Inflection points: 

• Advance previously announced large-scale colorectal cancer trials in Europe, US and Asia.
• Advance the clinical trial program for lung cancer, focusing initially on the significant need in Asia, most notably in China.
• Through subsidiary Volition Veterinary, determine and announce the route to revenue for Nu.Q Vet with the aim of having a USDA-approved product in 2020.
• Announce the results of multiple proof-of-concept studies to include prostate, pancreatic and ovarian cancers.
• Announce preliminary results of Nu.Q’s performance in other diseases, including endometriosis.
• Advance the development of Nu.Q Capture by determining the level of discrimination of tumor-associated nucleosomes using mass spectrometry and sequencing.

What the boss says: 

“We are an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health, “ VolitionRx CEO Cameron Reynolds said.

“This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. We believe the last decade of work and our extensive intellectual property portfolio puts Volition in a strong position to be a significant player in this field.”

Story by ProactiveInvestors