VolitionRx said it will pursue a CE mark application later in 2014 or early 2015 based, in part, on initial positive results from a major study involving its noninvasive colorectal cancer diagnostic test panel.
The company, based in Belgium and Singapore, also revealed it raised just over $1.1 million through the sale of shares that it expects to use to propel ongoing operations and clinical trials.
VolitionRx is moving ahead with its plans following its Sept. 11 presentation of topline data at the 2014 Aegis Capital Healthcare & Technology Conference. The massive colorectal trial in Denmark focused on a whopping 4,800 subjects. Initial results from a 938-subject sample showed the test panel could correctly spot 84% of colorectal cancers at 78% specificity, including those occurring at an early stage. Those tests also spotted 60% of polyps, and all the results involved patients over age 50 who had displayed colorectal cancer symptoms.
Of course, results from the broader trial will be key, but early data is encouraging for VolitionRx and its NuQ diagnostic panel. According to the company, the diagnostic process involves three individual assays, each of which uses a tiny amount of blood and identifies and measures a separate nucleosome structure in the blood sample. Nucleosomes in the bloodstream indicate cancer is present.
Even more intriguing, the results suggest the diagnostic panel could detect both early stage and late-stage cancer with similar accuracy.
Colon cancer is often not identified until it is fairly far advanced, which makes it difficult to treat. The most common testing methods are also quite invasive (biopsies/colonoscopies) or imprecise (fecal tests). That reality leaves the door wide open for a research team or company that can produce a less-invasive and more accurate colorectal cancer-screening test.
Many are trying. Exact Sciences ($EXAS) in August won FDA premarket approval for its new Cologuard colorectal cancer-screening test, the first FDA-approved noninvasive stool DNA screening test for colorectal cancer. It also has a slightly better track record; the company noted at the time that Cologuard can identify 92% of cancers and 69% of the most advanced precancerous polyps in typical patients.
There's also Epigenomics, which is based in Germany and Maryland in the U.S., and trying to obtain FDA PMA approval for a blood test that would achieve early detection of colorectal cancer. But U.S. regulators' questions and concerns have led to delays in that process.
|VolitionRx CEO Cameron Reynolds|
VolitionRx is plowing ahead with a bid to obtain much more data. The company said that collection has begun for a 14,000-subject screening study in Denmark. Further analysis of the 938 initial subjects will also be made public at another research conference later this year.
For now VolitionRx CEO Cameron Reynolds issued bullish and optimistic statements about the initial data from those 938 patients.
"An accurate, early and cost effective blood test to screen for colorectal cancer would mark a revolutionary advancement in the way we test for and diagnose this terrible disease," he said in VolitionRx's announcement, arguing that NuQ does the job.
Further data from those massive studies will confirm this. Regulators in the European Union (and eventually the U.S.?) will also need to be convinced. But the preliminary results are a step in the right direction.
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