VNRX Scores High Quality Sample Base

Zacks Small Cap Research

By Brian Marckx, CFA

VNRX Scores High Quality 10,800 Sample Base Which Could Catalyze CE Mark Submission for CRC

This morning (5/29/13) VolitionRx (VNRX) announced they signed an agreement with Hvidovre Hospital at the University of Copenhagen in Denmark whereby VNRX will obtain ~10,800 patient blood samples for analysis with VolitionRx's NuQ tests.

4,800 of the samples were collected by Hvidovre Hospital under the direction of Professor Hans Jorgen Nielsen (Professor of Surgical Oncology at the Department of Surgical Gastroenterology) from 2010 - 2012.  These patients had colorectal cancer as well as other diseases.  They also underwent colonoscopies, which along with a plethora of patient background, treatment and follow-up data, makes for a very robust set of data for VolitionRx to use in their analysis of the samples with their NuQ tests which will initially use the samples for detection of colorectal cancer.  Not only is the sample and data set high quality and comprehensive, it comes at almost no cost to VNRX with Professor Nielsen offering the samples for free in the hopes it will advance VNRX's efforts in bringing an early cancer detection test to market.

VNRX expects to begin analysis next month (June) of the first 1,000 samples.  We expect analysis could be done in a matter of a few months.  It's anticipated that this 1,000-patient data will then be used to support a CE Mark application for a colorectal cancer test, which we think could happen by either late 2013 or early 2014.  We continue to look for CE Mark to be granted in 2014

The other ~6,000 samples will be collected in a prospective trial which will be jointly funded by VNRX, the University of Copenhagen and a "top ten global diagnostics company."  The samples will be collected at the University of Copenhagen under the direction of Professor Nielsen.  Collection is anticipated to commence in April 2014.  The samples will be provided to VNRX blinded and randomized.  VNRX anticipates they will spend only about $1.8 million for collection of these samples.

We view this morning's news as a significant positive for moving VNRX's development programs forward.  This provides the company with a very large, high quality sample and data set for a fraction of the cost that they would have had to spend had they run prospective studies on their own (which could have easily cost $10 million - $25 million) and also now puts a more definitive timeline on when CE Mark application could happen.  The data from these studies are also expected to be used to help support an eventual FDA filing.

In November 2012 VNRX announced very encouraging results using their tests in a small internal study on three cancer types, including colorectal.  The ~10,800 samples from both these new studies should provide an excellent gauge as to how VNRX's NuQ technology performs relative to detection of colorectal cancer as compared to that of colonoscopy, which remains the most effective diagnostic for colon cancer.  There are significant drawbacks of colonoscopies, namely, at about $1,000 per procedure, it’s a relatively high cost screening tool (particularly compared to VNRX's relatively inexpensive testing option) and it's very invasive, uncomfortable and time consuming, requiring the patient to be sedated as a fiber optic camera is threaded through the interior walls of the rectum and colon.  Approximately 3.1 million colonoscopies are performed in the U.S. every year (and about 4.1 million done in Europe) which indicates that despite the drawbacks, there's a very substantial market for colonoscopies.  Presumably even more people would go to their doctor to be tested for colon cancer with the availability of an accurate, easy to use, inexpensive and non-invasive screening test such as NuQ.  As such, we view colon cancer as an enormously attractive market opportunity for VNRX.

Colon
Cancer

Incidence and Prevalence:
  About 150k new cases of colon cancer are diagnosed each year which, among women, is the third highest incidence rate (behind breast and lung) and, among men, is the second highest rate (behind lung).  There are currently about 1.2 million Americans living with colon cancer

Deaths:
about 50k Americans die from colon cancer every year, which is second only to lung cancer in men and third to breast and lung cancer in women

Stage at diagnosis:
about 18% of colon cancers are diagnosed at the advanced stage

Mortality
: colon cancer has the third most dire five-year survival rate, behind only lung and pancreatic cancers.  Average five-year survival of colon cancer is about 50%.  While an early stage diagnosis can mean an average expected five-year survival rate of about 90%, a late-stage diagnosis can drop expected five-year survival to about a 10% chance.

Colon Cancer Stage At Diagnosis                 

View gallery

.

View gallery

.
Colorectal cancer stage distribution at diagnosis
    
                                                                                                                                

 

 

 








Colon
Cancer 5-yr CFA

VNRX Scores High Quality 10,800 Sample Base Which Could Catalyze CE Mark Submission for CRC

This morning (5/29/13) VolitionRx (VNRX) announced they signed an agreement with Hvidovre Hospital at the University of Copenhagen in Denmark whereby VNRX will obtain ~10,800 patient blood samples for analysis with VolitionRx's NuQ tests.

4,800 of the samples were collected by Hvidovre Hospital under the direction of Professor Hans Jorgen Nielsen (Professor of Surgical Oncology at the Department of Surgical Gastroenterology) from 2010 - 2012.  These patients had colorectal cancer as well as other diseases.  They also underwent colonoscopies, which along with a plethora of patient background, treatment and follow-up data, makes for a very robust set of data for VolitionRx to use in their analysis of the samples with their NuQ tests which will initially use the samples for detection of colorectal cancer.  Not only is the sample and data set high quality and comprehensive, it comes at almost no cost to VNRX with Professor Nielsen offering the samples for free in the hopes it will advance VNRX's efforts in bringing an early cancer detection test to market.

VNRX expects to begin analysis next month (June) of the first 1,000 samples.  We expect analysis could be done in a matter of a few months.  It's anticipated that this 1,000-patient data will then be used to support a CE Mark application for a colorectal cancer test, which we think could happen by either late 2013 or early 2014.  We continue to look for CE Mark to be granted in 2014

The other ~6,000 samples will be collected in a prospective trial which will be jointly funded by VNRX, the University of Copenhagen and a "top ten global diagnostics company."  The samples will be collected at the University of Copenhagen under the direction of Professor Nielsen.  Collection is anticipated to commence in April 2014.  The samples will be provided to VNRX blinded and randomized.  VNRX anticipates they will spend only about $1.8 million for collection of these samples.

We view this morning's news as a significant positive for moving VNRX's development programs forward.  This provides the company with a very large, high quality sample and data set for a fraction of the cost that they would have had to spend had they run prospective studies on their own (which could have easily cost $10 million - $25 million) and also now puts a more definitive timeline on when CE Mark application could happen.  The data from these studies are also expected to be used to help support an eventual FDA filing.

In November 2012 VNRX announced very encouraging results using their tests in a small internal study on three cancer types, including colorectal.  The ~10,800 samples from both these new studies should provide an excellent gauge as to how VNRX's NuQ technology performs relative to detection of colorectal cancer as compared to that of colonoscopy, which remains the most effective diagnostic for colon cancer.  There are significant drawbacks of colonoscopies, namely, at about $1,000 per procedure, it’s a relatively high cost screening tool (particularly compared to VNRX's relatively inexpensive testing option) and it's very invasive, uncomfortable and time consuming, requiring the patient to be sedated as a fiber optic camera is threaded through the interior walls of the rectum and colon.  Approximately 3.1 million colonoscopies are performed in the U.S. every year (and about 4.1 million done in Europe) which indicates that despite the drawbacks, there's a very substantial market for colonoscopies.  Presumably even more people would go to their doctor to be tested for colon cancer with the availability of an accurate, easy to use, inexpensive and non-invasive screening test such as NuQ.  As such, we view colon cancer as an enormously attractive market opportunity for VNRX.

Colon
Cancer

Incidence and Prevalence:
  About 150k new cases of colon cancer are diagnosed each year which, among women, is the third highest incidence rate (behind breast and lung) and, among men, is the second highest rate (behind lung).  There are currently about 1.2 million Americans living with colon cancer

Deaths:
about 50k Americans die from colon cancer every year, which is second only to lung cancer in men and third to breast and lung cancer in women

Stage at diagnosis:
about 18% of colon cancers are diagnosed at the advanced stage

Mortality
: colon cancer has the third most dire five-year survival rate, behind only lung and pancreatic cancers.  Average five-year survival of colon cancer is about 50%.  While an early stage diagnosis can mean an average expected five-year survival rate of about 90%, a late-stage diagnosis can drop expected five-year survival to about a 10% chance.

Colon Cancer Stage At Diagnosis                 

View gallery

.

View gallery

.
Colorectal cancer stage distribution at diagnosis
    
                                                                                                                                

 

 

 








Colon
Cancer 5-yr Survival By Stage

 

View gallery

.
Colorectal cancer survival by stage at diagnosis

 





 









We cover VNRX with an Outperform rating.  See below for access to our full 25-page report on the company. 

A copy of the full research report can be downloaded here >> VolitionRx Report

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