Is deCODE T2™ an FDA approved test?
No, this is a reference laboratory test that has not been cleared or approved by the FDA. deCODE’s laboratory in Iceland that conducts the test is registered as a high-complexity laboratory under the Clinical Laboratory Improvement Amendments (CLIA). Using this test as a means of assessing genetic susceptibility to type 2 diabetes, as presented on this site and elsewhere, is based upon published studies by deCODE and independent researchers demonstrating the correlation of the tested variants with increased risk of developing T2D. This correlation has been demonstrated in numerous independent cohorts of patient across multiple populations and ethnic groups from around the world.
