C2N Diagnostics’ PrecivityAD2 blood test has received clearance from the US Food and Drug Administration (FDA), becoming the first Alzheimer’s disease test cleared by the agency for use in patients as young as 40 years old.

The blood-based test is indicated for adults aged 40 and above who have symptoms of cognitive impairment and are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

PrecivityAD2 is designed to be used alongside a clinical assessment to help healthcare professionals identify patients with amyloid pathology associated with Alzheimer’s disease. The company noted that the test is not intended for screening or as a standalone diagnostic tool.

The test uses high-resolution mass spectrometry (HRMS) to measure multiple blood-based biomarkers associated with both amyloid and tau pathology. It quantifies specific plasma beta-amyloid and tau peptide isoforms, including the Aβ42/40 ratio and p-tau217/np-tau217 ratio.

These measurements are combined through a statistical algorithm to generate an Amyloid Probability Score 2 (APS2)ranging from 0 to 100, indicating the likelihood of amyloid pathology associated with Alzheimer’s disease.

According to C2N, around 20 million US adults aged 65 and older, along with thousands of people between 45 and 65, are living with cognitive impairment and could potentially benefit from earlier identification of Alzheimer’s disease.

“This FDA clearance is a watershed moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine,” said Dr Joel Braunstein, CEO, C2N Diagnostics.

He added that the company believes PrecivityAD2 could help health systems streamline and simplify the complex diagnostic pathway faced by patients experiencing significant memory concerns.