C2N Diagnostics products

The PrecivityAD® Blood Test Answers Calls from Patients, Advocates, and Healthcare Providers Who Want Earlier Answers. Summary of Test and Patient Selection. The PrecivityAD® test identifies whether a patient is likely to have the presence or absence of amyloid plaques in the brain, a pathological hallmark of Alzheimer’s disease. The test relies on precise and robust quantitation of Amyloid Beta 42/40 ratio (Aβ 42/40) and detection of Apolipoprotein E proteotype (equivalent to ApoE genotype) in blood samples, using C2N’s proprietary mass spectrometry platform. Additional markers of Alzheimer’s disease, including p-tau217, are currently in development at C2N’s lab. The PrecivityAD® test is C2N’s initial test offering; it is expected to be part of a future Brain Health Panel offered by C2N that will measure multiple pathological markers for Alzheimer’s disease and related disorders.

The PrecivityAD2™ blood test is intended for patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia, who are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline. A multi-analyte clinical diagnostic tool developed by C2N Diagnostics, the PrecivityAD2™ blood test aids healthcare providers in the detection of brain amyloid plaques, one of the neuropathological findings of Alzheimer’s disease. The test’s proprietary Amyloid Probability Score 2 (APS2) result, which incorporates p-tau217/np-tau217 Ratio and Aβ42/40 Ratio using an analytically and clinically validated algorithm, correlates more closely with brain amyloid pathology as determined by PET scan than to the individual biomarker measurements considered separately.1

The PrecivityAD® test measures the concentrations of amyloid beta 42 and 40 (Aβ42 and Aβ40), as well as the presence of Apolipoprotein E (ApoE) isoforms in the blood. The test indicates if an individual is likely to have amyloid plaques in the brain, a hallmark of Alzheimer’s disease. ApoE4 genotype is a significant risk factor for brain amyloid accumulation and Alzheimer’s disease, and its incorporation into C2N’s proprietary algorithm increases the accuracy of the test. Using data from 686 patients, an algorithm based on plasma Aβ42/40 ratio, ApoE genotype, and patient age improved the separation between amyloid PET positive versus amyloid PET negative patients, as compared to using the Aβ42/40 ratio alone. For additional information about ApoE and sharing the results of ApoE genotype testing with your patients as part of the PrecivityAD® blood test, please download the ApoE overview.