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VolitionRx eyes commercialisation of first cancer test

Chief executive Cameron Reynolds told Proactive: "It's one thing to be a science project. It's another to have products and we are right on the cusp of that.”
VolitionRx eyes commercialisation of first cancer test
VolitionRX tests just use a small amount of blood

It's been a year of knocking down milestones at cancer diagnostics group VolitionRx (NYSE:VNRX), which is now eyeing the commercial launch of its most advanced colorectal cancer test kit.

Chief executive Cameron Reynolds told Proactive earlier this year: "It's one thing to  be a science project. It's another to have products and we are right on the cusp of that.

"We are aiming to have that first colo-rectal product this year," he said, adding that the firm was targeting first revenues for next year.

"We are also aiming to begin the process of US regulatory work through a 510k work this year and submitting that to the FDA next year (2017)," he added, explaining that that would help it get a US product as well as a European one.

Reynolds added it was in discussions with other groups over launching the product outside Europe and the US.

It is worth noting the firm also has positive results from its prostate cancer tests and  hopes to launch a test for clinical use in Europe in 2017.

Developing non-invasive tests

The company is developing a range of non-invasive tests for cancer and other conditions, in which just a drop of blood, or even less, is collected and the nucleosomes analysed to see if a cancer signature is present.

The group has trials underway worldwide  for these so-called NuQ tests to detect colorectal cancer, pancreatic cancer, prostate cancer, lung cancer and Idiopathic Pulmonary Fibrosis.

Notably, the technology has recently been endorsed by a study in Copenhagen, which said the nucleosomes in the tests were stable as biomarkers for colorectal cancer (CRC).

Awarded key CE marks.

A major milestone was reached in April this year, when the group was awarded CE marks for two of its blood-based tests - NuQV001 and NuQT003 -  for detecting colorectal cancer.

Crucially, it means it can sell three biomarker assays (because the first CE mark for NuQX001S was awarded last September) clinically in all member states of the European Union (EU), as well as Switzerland, Turkey, Iceland, Norway and Liechtenstein.

This would potentially reach a population of nearly 600mln. VolitionRx said it expects to launch a panel test for clinical use in Europe towards the end of 2016.

That came after recent data from a 430-subject trial, which demonstrated the blood tests accurately detected 86% of early-stage colorectal cancers at 78% specificity, as well as 75% of high-risk colorectal adenomas, or pre-cancerous polyps that were most likely to become cancerous.

Meanwhile, in May this year the group kicked off a large-scale study in Germany to detect early stage pancreatic cancer, and it is hoped it will complete this trial by the end of this year and if successful, to begin the regulatory work to sell clinically in 2017, starting in Europe.

Pancreatic cancer is one of the hardest forms of the disease to treat due to the often late diagnosis and the aggressive nature of the disease.

What the broker said:

In mid June, Rodman repeated a 'buy' recommendation on VolitionRx shares with a price target of US$12 each.

That's pretty considerable upside when you consider the shares are currently changing hands at around US$3.15 each.

Referring to the Scandinavian study, which validated the group's colo-rectal test, it said: "In our view, these results further validate the company’s NuQ as an accurate and easy-to-use diagnostic test.

"We remind investors that the NuQ blood test for CRC is on track for CE Mark approval and commercialisation in Europe by the end of this year.

"The final CRC test panel is likely to comprise 4-6 NuQ assays, of which two assays have already received CE Marks," the broker said..


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