CertuitAD: a blood test that helps test for Alzheimer's disease (AD) pathology1
What is CertuitAD?
CertuitAD is a blood test that measures P-tau2171.
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
Phlebotomy Services
A requisition form will be automatically generated by the ELCDL online portal and must be signed by the physician.
Quest Diagnostics® can provide phlebotomy services if needed. Patients can find their local Quest Patient Service Center (PSC) location at QuestDiagnostics.com/locations*. Appointments are highly recommended.
*ELCDL does not create or control the content of this website.
To request information on ordering CertuitAD, click here.
If you have an existing account on the ordering portal, please click here.
For questions or more information, please call the ELCDL at 833-INFO-CDL (833-463-6235) or email Diagnostic_Testing_Support@lilly.com.
Payment and Coverage Information
The list price of CertuitAD is $195. CertuitAD is currently not eligible for insurance reimbursement, including from private insurers, Medicare, or Medicaid. 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.
Footnotes
P-tau=phosphorylated tau.
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.