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.
The assay can also be used to assess a broad range of metabolic conditions, including pancreatic tumors, liver disease, acromegaly, and others.
As the diagnostics industry launches high-throughput systems to large labs for HbA1c testing, clinicians also see a market need for point-of-care testing.
The test on the Alinity platform is for use in the POC or clinical laboratory setting, and for the quantitative measurement of glucose in arterial and venous whole blood.
Clinical trials show that people who use the system, which eliminates a painful finger stick, test glucose levels an average of 15 times each day.
The first-ever study looking at diabetes in youths in the five major ethnic and racial groups in the US could not determine a reason for the spike in diabetes diagnoses.
The mySugr app will give Canadian users quick access to diabetes data and enable them to synchronize glucose levels with Roche's diabetes management system.
The firm said it is now an in-network provider with the country's fourth-largest health insurer.