Two months ago, cancer diagnostics group VolitionRx Limited (NYSE MKT:VNRX) told investors it had seen a strong start to 2017 with 'many milestones' passed, but its recently struck deal to take part in a large US clinical study of its NuQ test marked a real step change.
The study will see around 13,500 people tested and is a collaboration with the Great Lakes New England Clinical Validation Center funded by the US National Cancer Institute's (NCI) Early Detection Research Network (EDRN).
Significantly, VolitionRx will contribute around just $3mln towards the arrangement, as opposed to a $30-$40mln cost for a trial of this size.
Cameron Reynolds, chief executive, told Proactive this study was "about as big as it gets" and was a key trial in the biggest healthcare market in the world.
He said the group's strategy had always been to develop its colorectal screening test in Europe but then to launch it in the US.
"We believe this large scale clinical study will be invaluable when we seek FDA approval for Nu.Q."
Late in 2016 it achieved a CE mark for its Nu.QTM Colorectal Cancer Screening Triage Test , which was in itself a major milestone and paved the way for its expected launch across the European Union.
What does the company do?
The firm is focused on developing blood tests - called Nu. Q tests - to discover if someone has cancer, a disease for which a simple blood test is not normally an option.
The tests are based on the science of Nucleosomics, which identifies and measures nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.
Early diagnosis is key in cancer and can not only prolong the life of patients, but also to improve their quality of life.
New data revealed in May this tear confirmed previous test results that Volition's blood test can accurately detect colorectal cancer and reduce colonoscopies.
What's been happening this year?
In April, the firm started its first products study in Asia, while in Europe it has received ethical approval to proceed with the second and final phase for a triage study in Denmark.
The firm kicked off evaluating its Nu.QTM Colorectal Cancer Triage product in a Taiwanese population of 383 subjects.
Meanwhile, in Europe, Volition has received ethical approval to proceed with the second and final phase of the logistics and pathway design study for its Nu.QTM test in Denmark.
The study, conducted in collaboration with the Hvidovre Hospital and The Danish Research Group on Early Detection of Colorectal Cancer, deals with the practical issues of how the product fits into Denmark's current national screening program.
The group said results from the study are expected by the end of the third quarter this year.
What the broker said..
In May, broker Rodman & Renshaw repeated a 'buy' stance and targeted $10 a share (current price $3.21) after the group's first quarter results, which saw it post a net loss of $3.4mln - in line with the broker's projections of $3.3mln.
Analyst Raghuram Selvaraju said: "Combined with the fecal immunochemical test (FIT) score, the NuQ test is able to reduce colonoscopies by 25% while maintaining almost 97% detection of colorectal cancer.
"Management indicated that the logistical study of Nu.Q is progressing as planned in Denmark. We expect the study to complete in the coming months."
Rodman reckons the firm will start recognizing sales of Nu.Q in late 2017.
The broker also noted that VolitionRx aims to submit the test for regulatory approval in Singapore and Taiwan, adding that "potential approval in Singapore would allow the test to be marketed in nine other countries in the Association of Southeast Asian Nations (ASEAN)".