VolitionRx is a biotech small-cap dedicated to the development of blood-based diagnostic tests for different types of cancer, with an initial focus on colorectal cancer, the second deadliest cancer in the United States. After the age of 50, healthcare experts recommend a colonoscopy every five-10 years. Between these colonoscopies, people can use non-invasive tests that can sometimes determine the presence of cancer or even precancers. And here’s where VolitionRx steps in.
Currently, there are three main types of routing colorectal screening tests: Fecal occult blood tests (FOBT), Fecal immunochemical tests (FIT), and stool DNA tests (sDNA). Each type of test has its own drawback, and VolitionRx aims to fill the gap with accurate, non-invasive cancer blood tests that are easy and simple to use.
FOBTs are used the most frequently used test, most likely because of they are available for less than $25, and while a bit uncomfortable at the thought, are not physically invasive. However, these tests have a high false positive rate and low precancerous detection rate. Patients can also get a false positive with an FOBT if they have consumed vitamins, red meat, or fruits and vegetables prior to their bowel movement.
The FIT also detects blood in the stool, though it achieves a higher detection rate (37 percent) than FOBT. FIT is an immunochromatography-based test that detects hidden blood in the stool, which can be a sign of precancerous polyps or colon cancer. Because of the way it works, it does not give a false positive when patients eat certain fruits or vegetables. The downsides to this test are the approximately $100 cost and the fact that they may miss tumors that bleed in small amounts or not at all.
According to the Colon Cancer Alliance, a new generation of stool DNA tests is on the horizon. These tests have the potential to detect tumors at an early stage, including those not picked up by a colonoscopy, by focusing on a different process in the cancer cells and measuring mutations in DNA. While these are more accurate than blood tests, no single mutation predicts a patient’s risk and researchers have not seen a decisive improvement. In addition, these tests are very pricey, averaging $300 a piece.
Early detection provides the greatest chance for curing the disease and for survival, though 20-40 percent of patients are diagnosed with colorectal cancer in the later stages, when surgical removal is not a curative option. The majority of screens that catch polyps will find them while they are adenomas vs. precancerous polyps, the stage at which cancer is best prevented.
VolitionRx is developing two types of non-invasive cancer diagnostic tests based on its patented Nucleosomics® technology, supporting the company’s overarching goal to bring to market its cancer blood tests and revolutionize cancer diagnosis.
While VolitionRx’s current focus is on the detection of colorectal cancer, future plans call for expansion into detection of various other cancers as well. Following ongoing clinical trials and regulatory approval, the company plans to offer its tests for individualized cancers under the NuQ® brand.
VolitionRx has developed a range of about 20 individual assays, and plans to continue developing additional assays; an optimal panel of assays (typically 4-5) will then be selected. Each panel of tests requires a very small amount of blood, can be turned around in a day, and is very cost effective.
In December, 2013, VolitionRx announced findings that when combining two of its proprietary NuQ® assays into one test, they can achieve 85 percent detection rates at 85 percent specificity for colorectal cancer. The data also shows that Volition’s two-assay test can detect more than 50 percent of precancerous polyps.
The company’s R&D efforts are in Belgium, as the company markets its products in Europe where there is an easier path to regulatory approval. VolitoinRx plans to expand its marketing and commercialization to the United States, and then to the rest of the world.
For more information visit www.volitionrx.com
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