C2N Diagnostics, Used in Clinical Trials for LEQEMBI™ for Alzheimer’s Disease Treatment1,2, Is Poised to Support Medical Community in Next Steps

Health Care Providers Begin to Register to Use C₂N’s Analytically and Clinically Validated PrecivityAD2™ and Precivity-ApoE™ Blood Tests to
Meet Treatment Testing Requirements

ST. LOUIS--(BUSINESS WIRE)--C₂N Diagnostics, a leader in advanced brain health diagnostics, recognizes the landmark decision by the U.S. Food and Drug Administration to approve anti-amyloid antibody lecanemab (to be sold by Eisai Co., Ltd. as LEQEMBI) for intravenous use in the treatment of Alzheimer’s disease.

As stated in the FDA-approved LEQEMBI label, treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of the disease and confirmed presence of amyloid beta (Aβ) pathology. C₂N believes it is uniquely positioned to support the medical community in confirming this pathology with its Precivity™ portfolio of tests.

The newest addition to C₂N’s clinical offering will be the PrecivityAD2™ test, which 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. The PrecivityAD2™ blood test is intended for patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia, who are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

Healthcare providers are encouraged to visit www.precivityad.com to set up, register, and confirm accounts in advance of C₂N’s planned launch of PrecivityAD2 in mid-August.

Providers will have the option to also order the separate Precivity-ApoE™ proteotype blood test to determine their patients’ ApoE genotype status, which may assist in medical management and treatment decisions of patients with Alzheimer’s disease who are candidates for amyloid-reducing therapies.

Given the strong interest in LEQEMBI, it is anticipated meeting the testing requirements to receive treatment will necessitate the use of additional testing methods beyond a PET scan or spinal tap, both of which may be expensive, inaccessible, and uncomfortable.

Last year C₂N Diagnostics and Eisai Co., Ltd., announced they had entered into a collaboration to build awareness about how blood tests for cognitive impairment, including Alzheimer’s disease, may help patients receive a timely diagnosis and appropriate treatment, especially in traditionally underserved communities.

About C₂N Diagnostics, LLC

C₂N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C₂N strives to provide exceptional laboratory services and products 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’s assays have been used in over 100 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 10,000 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, BrightFocus Foundation and Alzheimer’s Association. For more information visit www.C2N.com.

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¹ McDade E, Cummings JL, Swanson CJ, et al. Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study. Alz Res Ther 2022;21:14(1):191. doi: 10.1186/s13195-022-01124-2.
² van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer’s Disease. N Engl J Med 2023;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.