C2N Diagnostics’ PrecivityAD2 test had secured US Food and Drug Administration (FDA) clearance, making it the first Alzheimer’s test to be cleared by the agency for use in patients as young as 40.
PrecivityAD2, a blood test, is indicated for use in adults aged 40 and above who present with symptoms of cognitive impairment who are undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline.
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Research indicates that approximately 20 million US adults aged 65 and older, along with thousands more between the ages of 45 and 65 are living with cognitive impairment and could benefit from an early Alzheimer’s diagnosis.
PrecivityAD2 is intended to be used in conjunction with clinical assessment to assist health care professionals (HCPs) in evaluating cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease and is not intended as a screening or standalone diagnostic test, C2N noted.
Referring to the abnormal build-up and clumping of a protein fragment called beta-amyloid, amyloid pathology is a hallmark of Alzheimer’s disease alongside tau, a protein that builds up and sticks together, forming neurofibrillary tangles that drive memory loss in the neurodegenerative disease.
C2N’s test uses high-resolution mass spectrometry (HRMS), the gold standard in clinical laboratory medicine, for measuring protein biomarkers from blood, quantifying protein biomarkers and simultaneously measure amyloid and tau pathology.
Once undertaken, PrecivityAD2 quantifies multiple specific plasma beta/β-amyloid and tau peptide isoforms in the blood, expressing these values as the Aβ42/40 ratio and p-tau217/np-tau217 ratio (%p-tau217). These two ratios are combined into a statistical algorithm that is used to calculate an amyloid probability score 2 (APS2) ranging from 0-100 to identify the likelihood of amyloid pathology associated with Alzheimer’s disease.
C2N’s CEO, Dr Joel Braunstein, commented: “The FDA clearance is a watershed moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine.
“We believe the PrecivityAD2 test will play a vital health system role in the years ahead to help streamline and simplify the complex diagnostic pathway that many patients face when dealing with serious memory concerns.”
Alzheimer’s space’s growth continuing at pace
Alzheimer’s disease research is continuing at pace, with GlobalData analysis revealing that the disease’s market is growing at a CAGR of 21.8% across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China) and is projected to reach a valuation of $33bn in 2033.
FDA approval of C2N’s Alzheimer’s test puts it in market contention with the likes of Roche’s Elecsys tests. The company’s Elecsys pTau181, a blood-based biomarker test for the preliminary evaluation of Alzheimer’s disease, secured FDA approval in October 2025, with its pTau217 blood test for pTau measurement obtaining a European CE mark in May 2026.
Beyond Alzheimer’s tests, the FDA’s approval of the first disease-modifying therapies (DMT) for the disease in the form of Biogen & Eisai’s Leqembi and Eli Lilly’s Kisunla in 2023 and 2024, respectively have attracted much of the interest in the space in recent years. Despite reimbursement challenges, each drug is expected to become a blockbuster therapy in 2027 and 2028, respectively, according to GlobalData analysis.
