Is deCODE Breast Cancer™ an FDA approved test?
No, deCODE BreastCancer™ is a reference laboratory test that has not been cleared or approved by the FDA. The laboratory that conducts the test is registered as a high-complexity laboratory under the Clinical Laboratory Improvement Amendments (CLIA). The clinical utility of this test as a means of assessing inherited susceptibility to breast cancer, as presented on this site and elsewhere, is based upon published studies by deCODE and independent researchers demonstrating the correlation of carrying at-risk deCODE BreastCancer™ genotypes and the increased likelihood of breast cancer.
