Over the next three years, Immunovia and its partners will use the firm's Immray PanCan-d assay to screen 6,000 diabetes patients for pancreatic cancer.
In a study of genetic variants associated with glycated hemoglobin in a meta-analysis, researchers found a G6PD variant leading to deceptively low blood sugar levels.
Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month.
On a conference call, the firm's CEO said that it and other industry players are pushing to postpone implementation of PAMA to no earlier than July 1, 2018.
Axon will distribute Biosurfit's POC instrument as part of the deal, which follows earlier agreements between the two firms covering Austria, Croatia, Slovakia, the Czech Republic, and Slovenia.