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 US Food and Drug Administration (FDA) has not approved or cleared this test. ELCDL is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.
This is an LDT for use in the United States only and cannot currently be used for patients in New York, California, Maryland, Pennsylvania, Rhode Island, or Washington DC until state-specific approval is granted.1