Aug 9, 2017
As we all know, the earlier cancer is diagnosed, the better the chances of survival. Colorectal cancer is ranked second among all newly diagnosed cancers, responsible for nearly 700,000 deaths worldwide. Patients with bowel cancer caught early (at stage I) have an average 97% five-year survival rate. Currently, fewer than one in ten people are diagnosed at stage I, and once it has spread to later stages (stage IV), the chances of surviving five years or more falls to just 7%. This is the problem VolitionRx is tackling.
VolitionRx Limited (NYSE MKT: VNRX) is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.
We caught up with the President and CEO of Volition, Cameron Reynolds, to get more details about his company and their game changing blood-based cancer test, Nu.Q™.
1. How many people does colorectal cancer affect globally, and how many more cases could be treated if Volition’s product could be commercialized?
There are currently 1.4 million cases of Colorectal Cancer worldwide resulting in almost 700,000 deaths each year. This figure is predicted to rise to 2.4 million cases and 1.1 million deaths by 2030.
Participation in Colorectal Cancer Screening Programs varies across the globe, but taking the U.S as one example, in 2014 only 66% of the screen relevant population were screened. This means that about 23 million people of screening age were not getting tested as recommended. This ‘compliance’ problem is one of the biggest challenges we face with colorectal cancer screening and is one of the primary reasons colorectal cancer has become the second leading cause of cancer related death in the United States. Approximately 50,000 Americans die every year from colorectal cancer.
Screening can save lives but only if people get tested. It is unfortunate, as colorectal cancer is one of the slowest growing, most easily identifiable and most easily treated of cancers, but too many people simply aren’t getting tested because many don’t like the screening options currently available to them.
The National Colorectal Cancer Roundtable in the U.S estimates that if screening participation could be increased to 80% by 2018 then over 200,000 deaths could be prevented by 2030.
Blood tests are widely found to be more accessible than other screening test modalities (e.g. Colonoscopy / Fecal tests) and so the hope is that Volition’s Nu.Q™ Colorectal Cancer Screening Test can help drive participation in screening programs, thereby diagnosing more cancers earlier when treatment proves most effective. I think the only way that U.S. compliance rates will approach 80% is with an accurate blood test on the market available for patients, which is what Volition hopes to provide.
2. Can you give us more details about Volition’s colorectal cancer test, Nu.Q™?
It is a simple, affordable, blood based test which looks for Nucleosomics markers of cancer in circulation. The Nu.Q™ family currently consists of 38 Nu.Q™ blood biomarker assays that fall into 5 main families of double antibody ELISA assays. Each captures intact nucleosomes and labels (identifies) a specific structural feature out of thousands of potential biomarkers. Nu.Q™ is protected by multiple patent coverage: 9 published patent families, including 4 granted U.S. patents.
We expect it to be the most accurate cancer blood test available.
3. What is the science of Nucleosomics®, and how is it more effective at detecting cancer than other methods being used now?
Cancer leads to irregular levels of uniquely structured nucleosomes in the blood. A nucleosome is a section of DNA wrapped around a core of proteins. Through a simple test, with a small amount of blood, we are able to detect those unique nucleosomes; and by measuring and analyzing them, our Nu.Q™ tests can identify patients who may have a cancer. This must then be confirmed by follow up procedures – for example, for colorectal cancer, a colonoscopy must be performed.
4. What are the advantages that the Nu.Q™ test has over other cancer diagnosis tests currently on the market?
The main advantages of Nu.Q™ over currently available tests are ease of use (for doctor and patient), cost and risk profile. Nu.Q™ only requires a small amount of blood and can be taken as part of a routine blood draw. There is no need for any preparation, change in diet, anesthesia, etc.
- Colonoscopy: expense (over $2000), invasive, preparation (unpleasant), compliance problems, risk of complication (10 times higher than for any other commonly used cancer-screening test), time required off work
- Sigmoidoscopy (for the lower bowel): not widely available, only detects cancer in lower colon
- FIT (Fecal test to detect if there is blood in stool): unpleasant, compliance problems, qualitative test not particularly accurate (FIT DNA test requires LARGE sample and is still expensive)
- FOBT (Fecal test to detect if there is blood in stool): compliance problems, unpleasant, requires 3 samples
5. You recently announced a colorectal cancer screening trial in collaboration with the U.S. National Cancer Institute. What does this mean for the development of the Nu.Q™?
This is a large clinical study providing approximately 13,500 asymptomatic screening samples of people of screen relevant age. The aim of the study will be to validate Volition’s Nu.Q ™ Colorectal Cancer Screening Test in a large asymptomatic population. Over 4,600 samples have already been collected and up to 9000 samples will be collected prospectively over the next 2-3 years. The study is in collaboration with the prestigious National Cancer Institute’s Early Detection Research Network and at a cost of up to $3 million paid in installments over that period represents exceptional value for money. To illustrate the order of magnitude, if we had chosen to conduct our own stand alone trial, the cost would have been more in the region of $30 million.
Upon completion of this trial and FDA approval, we expect to launch our front-line blood test for colorectal cancer in the U.S. This trial is a very significant milestone for Volition.
6. What are the short and long-term milestones for the company? What can investors expect as the major milestones that will drive shareholder value?
In the short-term, we continue to focus strongly on Colorectal Cancer and getting our first products to markets throughout Europe, Asia and the U.S. This includes our Nu.Q™ Colorectal Cancer Screening Triage Test as well as our front-line screening test. We have generated positive results in pilot studies of other cancers, notably, lung, pancreatic and prostate and so in the longer term we hope to launch products to help diagnose these other cancers too.
VolitionRx will be hosting a conference call on Thursday, August 10, 2017 at 8:30 am Eastern time to discuss its financial and operating results for the second quarter of 2017, in conjunction with the filing of its quarterly report on Form 10-Q for the quarter ended June 30, 2017. For details of the call, please visit the company’s website: http://ir.volitionrx.com/press-releases/detail/617
If you would like to keep up to date with Volition’s company news, please subscribe to our weekly newsletter: Life Science & Technology Weekly
+1 (646) 650 1351
(604) 488 8878
Disclaimer: NAI is being compensated for this article. Materials contained in this article is for information purposes only and is not intended to constitute an offering of securities in any jurisdiction. Nothing on this article should be construed as an offer, solicitation or recommendation to buy or sell products or securities.