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
What is CertuitAD?
CertuitAD is a blood test that measures P-tau217.1
What is P-tau217?
P-tau217, a soluble fragment of tau, is a biomarker associated with Alzheimer’s disease (AD) pathology.2,3
Who is the appropriate patient?
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
CertuitAD results must be interpreted in the setting of a thorough clinical evaluation. CertuitAD is not intended to be used as a screening or stand-alone diagnostic test and is not intended for therapeutic monitoring. A positive result by itself does not establish a diagnosis of AD. Additional laboratory testing (such as APOE genotyping) may be warranted based on the patient’s clinical presentation and/or family history.1
To request an account, please click here to fill out the intake form.
If you have already set up your account, please visit the ordering portal to initiate a CertuitAD order with Eli Lilly Clinical Diagnostics Laboratory, LLC.
Order CertuitADP-tau=phosphorylated tau.
Payment and Coverage Information
The list price of CertuitAD is $195. CertuitAD is not currently covered by insurance providers. Patients are responsible for paying out of pocket for the test.
Financial assistance and payment plans may be available for eligible patients. These programs are available based upon financial need. Patients may call 1-833-INFO-CDL (1-833-463-6235) for more information.
CertuitAD price reflects the cost of the test. Blood collection sites may charge additional fees.
References
- Data on File, Eli Lilly Clinical Diagnostics Laboratory, LLC, DOF-CT-US-0005.
- Cullen NC, Leuzy A, Janelidze S, et al. Plasma biomarkers of Alzheimer’s disease improve prediction of cognitive decline in cognitively unimpaired elderly populations. Nat Commun. 2021;12(1):3555. doi:10.1038/s41467-021-23746-0.
- Mattsson-Carlgren N, Janelidze S, Bateman RJ, et al. Soluble P-tau217 reflects amyloid and tau pathology and mediates the association of amyloid with tau. EMBO Mol Med. Published online May 5, 2021. doi:10.15252/emmm.202114022.
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