C₂N Diagnostics Statement on FDA Accelerated Approval of Aducanumab for Alzheimer’s Treatment
ST. LOUIS — June 8, 2021 — C₂N Diagnostics says the U.S. Food and Drug Administration’s (FDA) decision granting accelerated approval to aducanumab (Aduhelm) on the basis of amyloid plaque reduction for Alzheimer’s treatment represents a significant change in the ongoing fight against the horrible disease.
Dr. Joel Braunstein, C2N’s CEO, said, “The accelerated approval of aducanumab will offer a potential new option for patients, their families and clinicians to consider as part of a comprehensive care plan for Alzheimer’s disease. The FDA’s decision is consistent with C2N’s focus on the development and commercialization of impactful diagnostic tests that track the most important biological features of the disease. Starting with the PrecivityAD™ blood test, it’s possible to identify brain amyloid plaques from a single sample of blood and to aid in the early diagnosis of Alzheimer’s disease. Early intervention represents our greatest chance for delaying or halting future progression.”
The FDA said, “Patients receiving the [aducanumab] treatment had significant dose- and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.”
The Wall Street Journal, in a recent editorial about the drug, directly linked it to blood tests: “[w]ith the advent of blood tests that can identify people at risk for Alzheimer’s years before symptoms occur, millions more Americans could eventually benefit.”
While the test by itself cannot diagnose Alzheimer’s disease — which is a clinical diagnosis made by a health care provider — the test is an important means for physicians to aid in the evaluation process.
The PrecivityAD™ test does not involve any radiation and is non-invasive. These features make the test more accessible than other diagnostic methods that physicians use to evaluate issues with memory and thinking.
The proprietary test involves a small blood sample from a person’s forearm. C₂N analyzes the blood in its specialized laboratory facility using mass spectrometry to measure the concentrations of amyloid beta 42 and 40 (Aß42 and Aß40), and the presence of apolipoprotein E (ApoE) isoforms in blood. The analysis process is semi-automated and allows for C₂N to process samples in a routine and repeatable manner.
C2N offers the test now in 48 states, the District of Columbia and Puerto Rico.
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About C2N Diagnostics, LLC
C2N’s Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders. Diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. Its lead commercial product, PrecivityAD™, is a mass spectrometry-based test that measures in blood multiple analytes including Aβ42, Aβ40, and apolipoprotein E isoforms. This test predicts brain amyloid plaques as determined by PET scan results and in early 2019 it received a Breakthrough Device Designation from the U.S. Food and Drug Administration. For more information visit www.C2N.com.
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Adam Shapiro
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