LXN Gluco-Protein test launch planned :
This article was originally published in Clinica
Executive Summary
LXN is to launch its Gluco-Protein test in the US by the end of the year. The test, which the company claims is the first self-test for glycated protein (fructosamine), has been granted CLIA-waived status, which means that healthcare providers do not have to send samples for laboratory testing. Gluco-Protein, recently approved for over-the-counter sale by the FDA, will eventually be sold OTC as part of a monitoring device that also offers a rapid test for blood glucose. The two-test device, Duet Glucose Control Monitor, is pending FDA clearance.