A very important shot was fired last week in the battle for the colorectal cancer diagnostics market. Cancer diagnostics minnow VolitionRx (OTCQB:VNRX) announced the first tranche of data from its retrospective clinical trial with Hvidovre Hospital in Copenhagen, Denmark. The company announced that in a sample of 938 patients (a total of 4,800 to be analyzed), it had been able to detect an impressive 84% of subjects with colorectal cancers, as well as 60% of precancerous polyps or adenomas. Volition’s data further indicated that identifying colorectal cancer was not stage dependent, meaning that cancer was not only identified in the later stages, but cancer was identified in the early stages just as well. Furthermore, Volitions data does not come from a colonoscopy or fecal exam that has low patient compliance and high costs, but rather the data comes from a simple, inexpensive, blood-based diagnostic test. This data will surely be viewed with importance by those following Exact Sciences (NASDAQ:EXAS) and Epigenomics (OTCPK:EPGNF).
For the first time VolitionRx announced results of studies in a large number of subjects (~1000), in a blinded trial. The population analyzed was symptomatic – people visiting the hospital showing symptoms which could indicate colorectal cancer (e.g. rectal bleeding or severe weight loss). For this reason there were no true “healthy” people in VolitionRx’s population, and healthy individuals are arguably easier to differentiate from those with cancer, than symptomatic patients are. Knowing that its results may differ – either rise or fall – in a non-symptomatic, screening, population (where e.g. all adults aged 50-70 are given tests), VolitionRx is currently undertaking a 14,000-subject screening study in Denmark. Collection began in April of this year, and the company expects the first couple of thousand samples will be delivered for analysis in Q1, 2015.
There are several factors making VolitionRx’s results compelling. 84% identification of colorectal cancer from a blood-based test is a strong figure: in April this year, the FDA Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel chose to recommend, with some reservations, the approval of a blood-based colorectal cancer diagnostic from Epigenomics. Epigenomics’ Septin-9-based test showed sensitivity of 68% at a specificity of 78% (68% detection of cancers with 22% false positives). This indicated that the FDA’s appetite for noninvasive blood-based diagnostics could possibly lead it to approve products with lower accuracy than other forms of testing, such as fecal testing or colonoscopy (especially given 35m Americans of screening age are still not screened for colorectal cancer). The Epigenomics’ results were from a screening study of 1,500 asymptomatic patients.
Another compelling factor is that VolitionRx’s results were not stage dependent, with the company saying that it could pick up cancers at early stages at the same accuracy as later-stage cancers. This is significant – colorectal cancer’s 5-year survival rate if caught at early stage is very good (around 74% if picked up at stage I), where mortality is much higher where the cancer is not picked up until later (only 6% if detected at stage IV). The company did not release a full breakdown of results by stage, but has promised further analysis of the data at a presentation of its results at the 9th International Conference of Anticancer Research next month.
VolitionRx has not yet released confirmed final prices for its tests, although it has indicated that it expects the price to be commensurate with the PSA (prostate specific antigen), the blood-based prostate cancer test. If so, this would put VolitionRx’s test in the region of -$75 or lower, which would make it highly competitive against the $599 Exact Sciences’ fecal-based test. And a blood-based test is likely to have much higher patient compliance as compared to patients having to collect their own fecal matter and send them in (only 40-70% of eligible individuals take fecal tests when offered them). It would be more directly competitive with Epigenomics’ test, which is expected to cost $150. The expected cost-effectiveness of VolitionRx’s test means that it could potentially find large markets in more price-sensitive world regions such as the EU, where there are 175m screening-age individuals, or even rising developing nations like China, India and Brazil. It is clear that if VolitionRx can offer its test at a competitive price, and can show in its screening study to have comparable or better results than Epigenomics, it will radically change the market.
A blood test such as VolitionRx’s is unlikely to completely replace the colonoscopy, particularly for high-risk patients, but blood-based diagnostics have the potential to completely change the colorectal cancer screening landscape, due to their ease of use, high patient compliance, low cost, and early detection. Colorectal cancer testing is a multibillion dollar market, and there is plenty of room for different kinds of tests, for different types of diagnosis, and a simple, cost effective, blood-based test would help to provide easy, periodic, and routine, cancer testing to millions who otherwise do not get tested as well as those who do. Whichever company can deliver accuracy in a screening population at a cost-effective price is likely to wipe the floor with the competition.
The recently released data requires any serious player in colorectal cancer diagnostics to do due-diligence on VolitionRX. Over the next 12 months VolitionRx plans to announce several clinical milestones that if successful would further place the company on the worldwide stage and likely propel the company’s current $30 million market cap in the direction of Exact Science’s $1.6 billion valuation. Exact Sciences, a pre-revenue company, commands this high market cap with only one FDA approved fecal test, a test that is expensive with known compliance rate issues. VolitionRx believes that its cheap, accurate, and easy to administer diagnostic test could be applicable to not only colorectal cancer, but other cancers as well. Up until now, VolitionRx has been a virtually undiscovered, unknown company, trading on the OTC Markets. The company is now worth putting on your radar given its recent results, competitive advantages, and the fact that it’s trading at a fraction, 2%, of Exact Sciences market cap.
The company’s most recent investor presentation can be downloaded [HERE].
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