FDA clears PrecivityAD2 Alzheimer’s blood test for symptomatic adults aged 40 and older

The clearance extends FDA-authorised blood-based assessment of Alzheimer’s-associated amyloid pathology to younger symptomatic adults, providing clinicians with a less invasive alternative to PET imaging and cerebrospinal fluid testing.

The US Food and Drug Administration (FDA) has cleared C2N Diagnostics’ PrecivityAD2® blood test to aid identification of amyloid pathology associated with Alzheimer’s disease in adults aged 40 years and older who have signs or symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

The clearance provides clinicians with a blood-based tool for assessing brain amyloid pathology in a younger symptomatic population, although PrecivityAD2 is not intended for screening or as a standalone diagnostic test.

Field	Content
Alert Type	Drug Approval
Drug Name	PrecivityAD2®
Indication	Blood-based in vitro diagnostic intended to aid healthcare professionals experienced in evaluating cognitive impairment in identifying amyloid pathology associated with Alzheimer’s disease in adults aged 40 years and older who present with signs or symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. It is not intended for screening or use as a standalone diagnostic test. (C2N Diagnostics)
Therapy Area(s)	Neurology; Alzheimer’s disease; Diagnostics
Geography	United States (FDA)
What Happened	On 20 August 2026, the FDA cleared C2N Diagnostics’ PrecivityAD2 blood test for symptomatic adults aged 40 years and older. The test uses high-resolution mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217, combining the results in an algorithm to assess the likelihood of brain amyloid pathology associated with Alzheimer’s disease. It is the first FDA-cleared Alzheimer’s blood test indicated for symptomatic patients from age 40, expanding blood-based assessment to a younger population than previously cleared tests. (C2N Diagnostics)
Why It Matters	Confirming Alzheimer’s-associated amyloid pathology has traditionally relied on approaches including PET imaging and cerebrospinal fluid testing. PrecivityAD2 provides clinicians evaluating cognitive symptoms with a less invasive blood-based option and extends FDA-cleared testing to adults from age 40, which is particularly relevant when investigating possible younger-onset disease. Results must still be interpreted alongside the patient’s clinical assessment and other diagnostic information. (C2N Diagnostics)
Supporting Context	In a clinical validation study involving 1,142 symptomatic adults, a positive PrecivityAD2 result had a 97.6% positive predictive value for amyloid pathology, while a negative result had a 93.1% negative predictive value, using amyloid PET or cerebrospinal fluid biomarker testing as reference methods. A “Likely Positive” result occurred in 17.3% of participants and had a 77.3% positive predictive value. (C2N Diagnostics)
Key Takeaway	FDA clearance of PrecivityAD2 gives clinicians a blood-based method for assessing Alzheimer’s-associated amyloid pathology in symptomatic adults from age 40, broadening the population that can access an FDA-cleared blood test during diagnostic evaluation. (C2N Diagnostics)
What to Watch	C2N expects the FDA-cleared version of PrecivityAD2 to become available later in 2026; its current CLIA-validated laboratory-developed version remains available in the meantime. (C2N Diagnostics)
Primary Source	C2N Diagnostics FDA clearance announcement
Relevant Date	20 August 2026

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