VolitionRx (NYSE:VNRX) took a step towards commercialising its innovative colorectal cancer tests in the USA - through a deal struck with Global Specimen Solutions (GSS), a specialty clinical research organisation.
Under the agreement, GSS will target and select US medical universities and commercial clinical laboratories providing diagnostic testing services as strategic collaboration partners for the testing of the group's NuQ colorectal cancer tests.
Through the partnership, the New York listed diagnostic specialist hopes to license its Nucleosomics biomarkers to labs in 2016.
VolitionRx's chief executive Cameron Reynolds told investors: "With world-class expertise in collecting and managing specimens for research, and a strong understanding of the technology trends, regulatory environment and competitive situation, GSS is an ideal partner to support VolitionRx's strategy to enter the US. market and gain FDA approval of our NuQ colorectal cancer tests.
"By first partnering with GSS to enter CLIA-certified labs and medical universities in the US., we believe that we will be well-positioned to initiate a bridging US. FDA-endorsed trial with our ongoing large trials in Europe, which will be designed to provide the clinical data to support PMA submission for the potential FDA approval of our NuQ tests for the early detection of colorectal cancer.
"In parallel, we aim to license our Nucleosomics biomarker panels in the US for development as an LDT (laboratory developed tests) in 2016, and provide VolitionRx with early revenue, while proceeding with the FDA approval process."
Mark Eccleston, business development director at VolitionRx, added: "Collaborating with GSS in the US augments our primary commercialisation strategy to gain approvals in both Europe and the US in alignment with swift market entry across these regions.
"Our objective is to work with GSS to identify and select key US. partners to develop our Nucleosomics biomarkers as an LDT and we look forward to providing further updates on this process."