Intended Use
CertuitAD is intended to be used in patients aged 60 years and older who present with cognitive impairment and who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline.1
LDT Disclaimers
This laboratory developed test (LDT) was developed and its performance characteristics determined by Eli Lilly Clinical Diagnostics Laboratory, LLC (ELCDL). The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. ELCDL is a CAP (College of American Pathologists) accredited laboratory and is certified under CLIA (Clinical Laboratory Improvement Amendments) as qualified to perform high complexity clinical testing.
This is an LDT for use in the United States and may not be available in all states due to state licensure requirements.1