PrecivityAD
undisclosedbiomarker · high · Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Help healthcare providers assess whether a patient with cognitive impairment is likely to have amyloid plaques associated with Alzheimer's disease.
Blood-based biomarker test using Aβ42/40-based PrecivityAD assay; C2N's biomarker products are described as high-resolution mass spectrometry-based and LC-MS/MS-related.
Quality Improvement PrecivityAD Clinician Survey evaluated clinician experience with the commercially available PrecivityAD test.
In the Bio-Hermes analysis, PrecivityAD showed 80.7% overall percent agreement with florbetapir-PET and 86.0% positive predictive value for PET-positive patients.
PrecivityAD2
undisclosedbiomarker · high · Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Support diagnosis and clinical decision-making for Alzheimer's disease by using blood biomarkers, including p-tau217-related measurements, in patients with cognitive impairment or related populations.
Blood biomarker assay described in clinical trials as PrecivityAD2; publications describe C2N Diagnostics' PrecivityAD2 mass spectrometry assay measuring plasma phospho-tau217.
Clinical utility trial published on ClinicalTrials.gov in 2025 to test whether early PrecivityAD2 result disclosure shortens time to Alzheimer's disease or non-Alzheimer's diagnosis; 2026 Down syndrome exploratory study reported assay accuracy against amyloid PET.
In an exploratory Down syndrome-related Alzheimer's disease study, the C2N PrecivityAD2 mass spectrometry p-tau217 assay showed AUC 0.91, specificity 0.94, and overall accuracy 0.92 for amyloid PET-defined pathology.
PrecivityAD2 clinical utility study
exploratoryresearch program · high · Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Determine whether early PrecivityAD2 blood biomarker testing and disclosure, with optional Precivity-ApoE proteotype testing, shortens time to Alzheimer's disease or non-Alzheimer's diagnosis compared with delayed disclosure.
Randomized early versus delayed blood biomarker testing and disclosure study with one-year follow-up and optional participant/caregiver questionnaire sub-study.
ClinicalTrials.gov record published for NCT06856681.
Precivity-ApoE
undisclosedbiomarker · medium · Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Provide discretionary ApoE proteotype information alongside PrecivityAD2 testing during Alzheimer's disease diagnostic evaluation.
Blood-based ApoE proteotype testing offered at clinician discretion in a clinical utility study with PrecivityAD2.
Included as discretionary testing in the Clinical Utility of Early vs. Late Blood Biomarker Testing for Alzheimer's Disease trial.
C2N-8E12
phase 1drug program · high · Wed Jul 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate a therapeutic candidate in patients with progressive supranuclear palsy.
Single intravenous infusion study assessing safety, tolerability, maximum tolerated dose, and pharmacokinetics.
Clinical trial record for safety, tolerability, and pharmacokinetics in progressive supranuclear palsy subjects.
High-resolution mass spectrometry brain health biomarker platform
undisclosedplatform · medium
Develop laboratory services and biomarker products that support clinical decision-making, neurodegeneration clinical trials, and research into mechanisms of disease.
High-resolution mass spectrometry-based biomarker products, including LC-MS/MS-related blood biomarker testing for Alzheimer's disease and related neurodegeneration.
Company site analysis describes C2N as providing laboratory services and products in brain health, with Precivity blood tests for amyloid plaque assessment.
