The Ischemia Care commercial laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). ISCDX is a Laboratory Developed Test (LDT).
CLIA - Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States. CLIA is governed by the Centers for Medicare and Medicaid Services (CMS).
LDT - A laboratory developed test is a type of blood test that is designed, manufactured and used within a single laboratory, that currently does not require FDA approval.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The CLIA Program receives oversight from CMS, the Food and Drug Administration (FDA), and Centers for Disease Control (CDC). In total, CLIA covers approximately 254,000 laboratory entities. Please see the following link for more information: