C2N Diagnostics Says FDA’s Approval of Donanemab Highlights Its Role in Helping to Determine Alzheimer’s Disease Pathology

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, a leader in advanced brain health diagnostics, is closely tracking today’s decision by the U.S. Food and Drug Administration to approve donanemab for treatment of early Alzheimer's disease. Researchers used C2N’s Precivity-p-tau217 blood biomarker in its Phase 3 clinical trial and analysis for donanemab, which was highlighted in the article “Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial¹” in the Journal of the American Medical Association.

Eli Lilly and Company says donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease. Exploratory outcomes included changes in plasma p-tau217 at 76 weeks and other time-based analyses. Lilly stresses that donanemab is not a cure for Alzheimer’s disease, but it has been shown to slow disease progression in clinical trials.

C2N believes it is uniquely positioned to support the medical community in confirming Alzheimer’s disease pathology with its Precivity™ portfolio of tests. The PrecivityAD2™ blood test is a clinical care assay that meets the standard of care with currently available PET scans and cerebrospinal fluid tests. This blood test is designed to alleviate the bottleneck and unmet needs of healthcare providers and patients in evaluating patients with signs and symptoms of Alzheimer’s disease and other causes of cognitive decline.

The PrecivityAD2 and the PrecivityAD® blood tests are intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.

Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “The Precivity™ tests continue to show their high accuracy and represent an important tool for the clinical research community to help evaluate emerging treatment strategies. Our experience with clinical studies evaluating donanemab and lecanemab, which received FDA approval last year, shows that we’re delivering on our promise to provide exceptional laboratory services and products in the field of brain health. C2N is proud to assist in bringing new innovative treatments to patients.”

The PrecivityAD2™ test uses a proprietary Amyloid Probability Score 2 (APS2) result that incorporates precise measurements of p-tau217/np-tau217 Ratio and Aβ42/40 Ratio into an analytically and clinically validated algorithm. The APS2 result correlates significantly and more robustly with brain amyloid pathology as measured by PET scan than to the individual Aβ42/40 and phosphorylated tau biomarker measurements considered separately.

About C2N Diagnostics, LLC

C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com.

¹ Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023;330(6):512–527. doi:10.1001/jama.2023.13239