C2N Diagnostics has submitted a regulatory filing to the U.S. Food and Drug Administration for its Alzheimer’s disease blood test, a milestone the firm calls a first in the field of medicine.
The test combines high-resolution mass spectrometry to measure multiple plasma β-amyloid and tau peptide isoforms. These concentrations are expressed as ratios (Aβ42/40 and p-tau217/np-tau217), then fed into a proprietary algorithm that yields a numerical score indicating the likelihood of brain amyloid pathology, a hallmark of Alzheimer’s disease, according to the company.
C2N claims this is the first multi-analyte, algorithmic blood test using high-resolution mass spectrometry ever submitted for FDA review for Alzheimer’s pathology assessment. The company currently offers the Precivity line of blood tests to patients 50 and older with signs of mild cognitive impairment or dementia, operated in its CAP-accredited, CLIA-certified, ISO 13485 laboratory in St. Louis.
The submission builds on published clinical research in the Journal of the American Medical Association, in which the PrecivityAD2 test demonstrated over 90 % accuracy at a pre-defined cutoff compared to cerebrospinal fluid or amyloid PET reference measures, the company said.
C2N was also granted Breakthrough Device status by the FDA in 2018, designed to accelerate review for devices addressing serious or unmet medical needs.
If approved, the test could expand clinicians’ options for noninvasive Alzheimer’s diagnostics and further C2N’s position in the growing Alzheimer’s biomarker market.
