C2N Diagnostics: FDA Approval of Donanemab Highlights Role in Alzheimer’s Detection

ST. LOUIS—C2N Diagnostics, recognized for its innovation in brain health diagnostics, is actively monitoring the recent FDA approval of donanemab for the treatment of early Alzheimer's disease. The approval is based on research that utilized C2N’s Precivity-p-tau217 blood biomarker, as detailed in the Journal of the American Medical Association's article, “Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.”

Eli Lilly and Company, the developer of donanemab, reports that the drug significantly slows cognitive and functional decline in individuals with early symptomatic Alzheimer’s disease. The clinical trials included exploratory outcomes that observed changes in plasma p-tau217 over a 76-week period, among other time-based analyses. Despite these advancements, Lilly emphasizes that donanemab is not a cure, though it does slow the progression of the disease.

C2N Diagnostics asserts its capability to aid the medical community in confirming Alzheimer’s disease pathology through its Precivity™ test portfolio. The PrecivityAD2™ blood test offers a clinical care assay that aligns with the current standards provided by PET scans and cerebrospinal fluid tests. This blood test aims to address the bottleneck faced by healthcare providers and patients in evaluating cognitive decline associated with Alzheimer’s disease and other conditions.

The PrecivityAD2 and the original PrecivityAD® blood tests are specifically designed for patients aged 55 and older who exhibit signs or symptoms of mild cognitive impairment or dementia and are undergoing evaluation for Alzheimer’s disease or other dementias.

Dr. Joel Braunstein, CEO of C2N Diagnostics, states, “The Precivity™ tests consistently demonstrate high accuracy and are vital tools for the clinical research community in assessing emerging treatment strategies. Our experience with clinical studies on donanemab and lecanemab, which received FDA approval last year, underscores our commitment to providing outstanding laboratory services and brain health products. C2N is honored to play a role in bringing new, innovative treatments to patients.”

The PrecivityAD2™ test features an advanced Amyloid Probability Score 2 (APS2) which integrates precise measurements of p-tau217/np-tau217 Ratio and Aβ42/40 Ratio into a validated algorithm. This APS2 result exhibits a stronger correlation with brain amyloid pathology as detected by PET scans compared to the individual biomarker measurements when considered separately.

C2N Diagnostics, LLC is dedicated to delivering exceptional clinical laboratory services and advanced diagnostic solutions for brain health. Utilizing high-resolution mass spectrometry-based biomarker services, C2N supports clinical decision-making, enhances the quality and efficiency of clinical trials for novel neurodegeneration treatments, and provides tools for healthcare researchers to explore new disease mechanisms, identify treatment targets, and conduct essential epidemiological studies aimed at improving public health globally.

C2N’s assays have been implemented in over 150 Alzheimer's disease and related research studies worldwide. The company has collaborated with multinational pharmaceutical and biotech firms, leading academic institutions, the National Institute on Aging, the Alzheimer’s Association, and other non-profits and consortiums. To date, more than 30,000 Precivity™-related biomarker measures have been documented in peer-reviewed publications, with numerous additional manuscripts pending review.

C2N acknowledges the generous support from the National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association, and BrightFocus Foundation.