VolitionRx Ltd (NYSEMKT:VNRX) has outlined its forthcoming strategy for its colorectal cancer screening test, which it reckons is the largest near term opportunity for the firm.
It is eyeing a launch of the diagnostic test in Europe in 2018.
The current 12 month plan sees a panel chosen for its Nu.Q colorectal cancer screening test for Europe in the fourth quarter of 2017.
In the first quarter of 2018 the chosen panel will be subject to validation in a 4,300-subject trial using secured samples from Danish cohorts, already acquired by Volition's subsidiary, Belgian Volition SPRL.
The panel will be subjected to further validation in a blinded 10,000-subject trial in the second quarter.
In the third quarter of 2018, CE Marking is expected to be completed on the chosen panel, so the product could be marketed in 28 European countries.
The CE Marking also offers a regulatory platform to expedite approval in many Asian markets.
"We believe that the market for the frontline screening test represents the largest near-term opportunity for Volition, as there are 150 million Europeans of screening age," said Cameron Reynolds, VolitionRx chief executive.
"Our strategy for Europe is now in place using patient samples that have already been secured in our very large ongoing Danish trials.
He added: "We look forward to executing on our worldwide strategies and to the anticipated launch of our frontline test in Europe in 2018."