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Company Takes Aim at Approval of Colorectal Cancer Screening Test in EU

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Two analysts take note as this biotech prepares to release data on its colorectal cancer screening product.

VolitionRx Ltd. (VNRX:OTCPK), developer of the Nu.Q frontline screening test for asymptomatic colorectal cancer (CRC), announced in September 2017 its plans to commence studies that would lead toward approval of the test in the European Union (EU). That strategy, along with plans to market the diagnostic in the United States and Asia, caught the attention of two stock-watchers.

The VolitionRx Nu.Q diagnostic "uses an array of simple, cost-effective, and accurate blood tests" to detect cancer in its early stages by identifying "irregular levels of uniquely structured nucleosomes" associated with the disease, according to the company. Its initial target is colorectal cancer, which VolitionRx maintains "is responsible for over 200,000 deaths in Europe each year, almost 50,000 deaths in the USA and nearly 700,000 deaths worldwide."

According to analyst Nathaniel Calloway of Edison Investment Research, the first step toward approval will be the release of results from a 680-subject trial of the product, which is currently underway. On February 5, VolitionRx announced successful conclusion of a "Logistics and Pathway Design Study" in Denmark, which concluded that "it was indeed possible to collect, process, gather and ship the blood test from all five participating hospitals to a central laboratory within 24 hours."

Positive results in the European trial is expected to support the company's goal of securing a CE Mark for the test. VolitionRx "will run two clinical trials (of 4,300 and 10,000 samples), which are expected to initiate in Q118 and Q218, respectively, supporting an expected CE mark and launch in Q318," Calloway wrote in a November 28, 2017 research report.

The company "is also participating in a three-year, 13,500-person US clinical trial including Nu.Q assays to support a US launch," Calloway stated, adding that, additionally, VolitionRx had "recently sold its first Nu.Q tests for research purposes to an undisclosed pharmaceutical company partner."

In a January 29 research report, Ram Selvaraju of H. C. Wainwright stated that his firm believes "the upcoming readout from the 680-subject trial is an important milestone" and will enable VolitionRx to move forward with more "fine-tuned" testing in its 4,300-subject trial.

"We expect the frontline screening test to be finalized after the 4,300-subject trial," Selvaraju wrote, noting that would enable the company to "enter a 10,000-subject trial in 2Q18."

At the same time, Selvaraju stated VolitionRx "aims to secure [a] CE Mark for the frontline asymptomatic CRC screening test by the end of 3Q18. Accordingly, we believe that this frontline test could be commercially launched in early 2019 in EU countries, which comprises roughly 150 million people eligible for CRC screening."

With regard to testing in the United States, Selvaraju expected this to conclude in 2020; testing in Asia will commence once Volition secures approval in the European Union (EU). According to Calloway, the testing in Asia will involve clinical trials in Taiwan and Singapore.

Calloway also noted that VolitionRx is developing Nu.Q screening tests for lung cancer and pancreatic cancer.

H. C. Wainwright has a $10 price target on VolitionRx stock, which is currently trading at around $3.04 per share. Edison has a $7.55 price target on the stock.

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Additional Disclosures

Disclosures from Edison Investment Research, Volition RX, November 28, 2017

This report has been commissioned by VolitionRx and prepared and issued by Edison for publication globally. Opinions contained in this report represent those of the research department of Edison at the time of publication.

Edison does not offer or provide personalised advice. We publish information about companies in which we believe our readers may be interested and this information reflects our sincere opinions.

Edison has a restrictive policy relating to personal dealing. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report. Edison or its affiliates may perform services or solicit business from any of the companies mentioned in this report.

Disclosures from H.C. Wainwright, Volition RX Ltd., Company Update, Jan. 29, 2018

I, Raghuram Selvaraju, Ph.D. and Yi Chen, Ph.D. CFA, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of VolitionRx Ltd. (including, without limitation, any option, right, warrant, future, long or short position).

As of December 31, 2017 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of VolitionRx Ltd.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did receive compensation from VolitionRx Ltd. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in VolitionRx Ltd. as of the date of this research report.

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