Excluding skin cancers, colorectal cancer (also called colon cancer, or bowel cancer) is the third most common cancer diagnosed in both men and women in the U.S. Every year in the U.S., more than 95,000 men and women will be diagnosed with colorectal cancer, and 50,000 will die of the condition annually. In Europe, this annual death number rises to more than 200,000, and globally, comes in at nearly 700,000.
A large majority of these deaths are preventable.
Patients with bowel cancer caught early (at stage I) have an average 97% five-year survival rate. If colorectal cancer is not caught until it has spread (stage IV), the chances of surviving five years or more falls to just 7%. Despite these figures, currently, fewer than one in 10 people are diagnosed at stage I.
The European Union, as well as a number of countries across the globe (not the U.S. yet, but it's only a matter of time) have mandated colorectal screening in an attempt to try and improve on the number of patients that receive early diagnosis and – in turn – qualify for a 97% five-year survival rate.
There's a secondary issue, however, and it's rooted in the accuracy of the current SOC diagnostics. These include a colonoscopy, and what's called a fecal immunochemical test (FIT). First, a patient has FIT. If it's negative, they repeat a year later. If it's positive, they go on to a colonoscopy – a procedure involving a physician using a thin camera to inspect the bowel wall. FITs will often result in false positives, however, and this translates to wasted time and money in physicians performing unnecessary colonoscopies.
One company that is trying to solve this issue is VolitionRX Ltd. (VNRX, Financial).
The company, based in Belgium, has developed a blood test called Nu-Q. It's designed as a second line diagnostic to the FIT test, targeting improved accuracy ahead of a patient needing to be booked in for a colonoscopy.
When a tumor develops, the tumor macro-environment is incredibly unstable compared to healthy environments. Cells are dying off frequently, and as they die, they release matter into the blood. Some of this matter is what are called nucleosomes. A nucleosome is a structural unit of a chromosome, consisting of a length of DNA coiled around a core of what are called histones, which are basically just a building block of a chromosome – a sort of glue, if you like. The nucleosomes of cancerous cells differ detectably from these of healthy cells. With its Nu-Q test, Volition is able to take a small drop of blood form a patient, add it to some market nucleosomes, and pull out a color-coded response that correlates with the number of cancerous nucleosomes present in the sample. The more cancerous nucleosomes, the more developed the cancer, and the more intense the color of the test on reading. As a side note, Nu-Q stands for nucleosome quantity. In a study presented last year, the company was able to demonstrate that the use of this test in line with the FIT test reduced the number of colonoscopies against a control group by 25%.
The test just picked up a CE mark, and while it's still early days in terms of development, it looks to be one of the most promising applications of blood test technology in the oncology space available right now. The European commercialization will serve as a bell weather for U.S. uptake. Having said that, with the European death count from colorectal cancer four times that of the U.S., and with the screening mandates in place, the European market is probably the most lucrative for the company as things stand.
Cancer blood tests are going to revolutionize the way we screen for cancer, and of course, Volition isn’t the only company developing a diagnostic. Indeed, another company is working on one in exactly the same indication. This isn’t a coincidence, of course. Colorectal cancer is infamous for the inaccuracy of its current SOC diagnostics, and also well known for its ability to be treatable with early identification (as mentioned above).
The company is TODOS Medical. This one is an Israel-based company that is targeting the same indication, but with a different end game in mind. TODOS' test is designed to reduce the requirement for colonoscopies based on the potential for human error in the process. A colonoscopy requires a human to interpret the results. This results in the missing of early stage cancers (as they can be tough to see) and in turn allowing these cancers to develop into fatal forms of the disease. TODOS is employing what's called Fourier transform infrared (FTIR) analysis, which fires infrared light through a sample of the patient's blood. Cancerous blood samples have a different atomic structure than non-cancerous samples, and the light reacts differently. The results of the test can then be fed through a computer, and the computer (by way of a piece of technology that TODOS has developed) determines whether the sample is cancerous or not.
Again, it's early on in the development stage for TODOS' test, but tests to date have demonstrated a high degree of accuracy when compared to colonoscopy analysis data. Further, these tests could be applied to many other types of cancer, with just the program that runs the tests requires to be changed to detect cancer specific atomic light responses.
This year is going to be a big year for oncology screening. With companies like these bringing blood tests to the fore, tests that are quick, cheap and – most importantly – accurate, the days of invasive and expensive testing will likely soon be over.
The author has no positions in any stocks discussed in this article.
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