The Precivity™ blood tests are clinical tools that aid healthcare providers in the diagnosis and treatment of Alzheimer’s disease. The PrecivityAD® and PrecivityAD2™ blood tests determine whether a patient with signs or symptoms of mild cognitive impairment or dementia has high or low likelihood of presence of brain amyloid plaques, one of the neuropathological findings of Alzheimer’s disease.

The PrecivityAD2™ and PrecivityAD® tests are multi-analyte blood tests developed by C₂N Diagnostics that determine a patient’s likelihood for presence of brain amyloid plaques. The Precivity-ApoE™ blood test determines a patient’s apolipoprotein E (ApoE) proteotype which can inform decision-making for optimal treatment pathways.

The PrecivityAD2™ blood test (Aβ42/40 Ratio + p-tau217/np-tau217 Ratio) measures specific amyloid beta (Aβ) and tau peptide concentrations in the blood to calculate a likelidood score – the Amyloid Probability Score 2 (APS2). The APS2 determines whether a patient is:

The PrecivityAD® blood test (Aβ42/40 Ratio + ApoE Proteotype + Age) measures specific amyloid beta (Aβ) and apolipoprotein E (ApoE) peptides in the blood and combines this information with a patient's age to calculate the Amyloid Probability Score (APS). The APS determines whether a patient has:

The Precivity-ApoE™ blood test measures apolipoprotein E (ApoE) isoforms to determine the presence of E2, E3, and/or E4 alleles. This provides the patient’s ApoE proteotype, which corresponds to APOE genotype and can help healthcare providers with treatment decisions.

The PrecivityAD2™ and the PrecivityAD® blood tests are intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia. The PrecivityAD® and PrecivityAD2™ blood tests are not intended for:

The Precivity-ApoE™ blood test is intended for use in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.

Only a healthcare provider can order the Precivity™ blood tests.

The Precivity™ blood test reports are issued to the ordering healthcare provider within 10 business days from receipt of the patient sample and completed paperwork.

The tests use a highly sensitive technique called liquid chromatography - mass spectrometry to measure specific peptides (small pieces of proteins) in the blood that are known biomarkers for Alzheimer’s disease. The peptide measurements are combined into proprietary clinically validated algorithms to determine the likely presence or absence of amyloid plaques in the brain as measured by amyloid PET scan.

Each of the Precivity™ blood tests are analytically and clinically validated and have high accuracy. The PrecivityAD2™ blood test and PrecivityAD® blood test have performance characteristics that have high correlation with amyloid PET scans and CSF testing for brain amyloid pathology.

Please refer to the Publications Tab for published research on the Precivity™ tests.

Currently there is no test that detects Alzheimer’s disease with 100% accuracy in patients being evaluated in the clinic. The Precivity™ blood tests for assessment of brain amyloid pathology offer an accessible and less procedurally-complex testing option for healthcare providers and patients compared to amyloid PET scan or CSF testing.

The Precivity™ blood tests may be appropriate for a patient with a family history of Alzheimer’s disease; however that patient should also be exhibiting signs or symptoms of cognitive impairment. The Precivity-ApoE™ test should only be used in adult patients for whom knowledge of apolipoprotein E2,E3,E4 allele status may be informative for medical management and treatment decisions.

There is no requirement for a formal memory assessment before prescribing Precivity™ blood tests. The PrecivityAD2™ and PrecivityAD® blood tests are indicated for use in patients who are aged 55 and older who are exhibiting signs or symptoms of cognitive impairment or dementia.

Please contact our Client Services team at 1-877-C2N-DIAG (226-3424) for answers to your questions about which Precivity™ blood test is right for you and your patients.

Healthcare providers can go to PrecivityAD.com Healthcare Provider Portal at HCP Portal to set up an account, or call 1-877-C2N-DIAG (226-3424).

Once a lab appointment has been scheduled for your patient, your office (or the lab facility collecting the blood) will receive the Precivity™ test kit on the day of the appointment. The test kit includes everything needed to collect the blood sample.

Your office or the selected lab will:

1. Draw from the patient 10.0 mL of blood into the K2 EDTA Vacutainer® tube;
2. Centrifuge the blood sample and transfer 1.2 mL of plasma into one Cryovial vial for PrecivityAD® and Precivity-ApoE™ tests and 1.2 mL into each of two Cryovial tubes for the PrecivityAD2™ test;
3. Place the transfer tube(s) containing the plasma in the return refrigerated or dry-ice shipper;
4. Call FedEx for pick-up. The return shipper box will be sent to the C₂N lab in St. Louis, MO, for testing by overnight express service.

If your office does not offer blood collection, your patient can schedule a blood collection appointment at a patient service center or call 1-877-275-2012 to arrange a convenient mobile phlebotomy visit at their home. More detailed information on blood collection services will be provided when you set up your test account.

The Precivity™ tests are new and are not currently covered by private insurance payers, Medicare or Medicaid.
Until each commercial and Medicare Advantage plan issues a positive coverage statement we will not know if the test will be covered by that plan. Commercial and Medicare Advantage plans may still pay for the test on a case-by-case basis without a formal coverage policy if the plan chooses to do so.

In the event a commercial or Medicare Advantage plan does not pay for the test, we will still pursue payment from the insurer.

Medicare beneficiaries should receive an Advance Beneficiary Notice (ABN) letter any time Medicare is not expected to pay for a service. Because Medicare has not evaluated the Precivity™ tests for coverage, C₂N does not expect Medicare to currently pay for these. Thus, an ABN letter should be provided to the patient prior to ordering the test.

Your patient will receive a bill in the mail after their medical claim has been sent to the healthcare provider. A financial assistance program is available for those patients that medically and financially qualify. A six-month, interest-free payment plan is also available to facilitate access to the Precivity™ tests. Please follow the instructions on the bill to make a payment. C₂N accepts major credit cards and personal checks. Your patient can make a payment online on our secure portal at Patient Portal, mail, or over the phone. For billing related questions, please call 1-877-C2N-DIAG (226-3424) for more information.

C₂N offers a financial assistance program to those that medically and financially qualify. Information about the program and how to apply are on our website at Cost & Billing. The patient will have up to 30 days from their first bill to complete the application. Please call 1-877-C2N-DIAG (226-3424) for more information.

The Publications and News tabs on our website (www.PrecivityAD.com) provides comprehensive information, as well as local and national resources, for individuals to learn more about Alzheimer’s disease. If your office does not have social services available to counsel your patient, you may consider referring your patient to your local Alzheimer’s Association chapter or your State’s Office of Aging.

For immediate response and support:

Alzheimer's disease is the most common cause of dementia, a general term for cognitive and memory loss serious enough to interfere with a person’s daily life. Alzheimer's disease accounts for 60-80% of dementia cases. For more information on Alzheimer’s disease, visit Alzheimer's Association or visit the Resource tab for additional information and resources.

Please refer to the Benefits of an Early Diagnosis document provided in the Patient & Caregiver tab Benefits of an Early Diagnosis. For additional information on Alzheimer’s disease and resources available, please visit the Resource tab.