ST. LOUIS--(BUSINESS WIRE)--Building on the first stage of its successful launch in the United States, C2N Diagnostics announces that the PrecivityAD™ blood test has achieved the CE Mark from the European Union (EU) as well as approval for its lab to conduct tests for California patients.
This means the PrecivityAD™ test, a unique mass spectrometry-based blood test for detection of Alzheimer’s disease pathology, has met the quality standards in compliance with In Vitro Diagnostic Medical Devices Directive 98/79/EC. This achievement allows for PrecivityAD™ test’s commercial availability in the EU as an in vitro diagnostic to aid in the evaluation of patients with mild cognitive impairment or very mild dementia and undergoing evaluation for Alzheimer’s disease.
The California news allows C2N to offer the test now in 46 states, the District of Columbia, and Puerto Rico.
These developments follow last month’s announcement that the PrecivityAD™ test has been clinically and analytically validated in compliance with U.S. CLIA standards; C2N is currently analyzing samples in its CLIA-certified laboratory.
C2N researchers found the PrecivityAD™ test predicts Alzheimer’s disease brain pathology in people age 60 and older with cognitive impairment; the test is only available through a health care provider’s prescription. Following the U.S. October launch, news reports stated that the company was the first to bring a blood-based Alzheimer’s test to the market.
Experts estimate that 20 million people over the age of 55 have mild cognitive impairment or very mild dementia in the EU alone, although most people have not been tested for disease pathology.
Joel B. Braunstein, MD, CEO of C2N says, “Our pursuit of the CE Mark and California lab certification demonstrates our confidence in the PrecivityAD test’s ability to aid in the diagnostic process for patients concerned about Alzheimer’s disease. In Europe, our immediate use of the test is as a validated biomarker for use in late-stage clinical drug studies. The use of this biomarker to aid in screening individuals for participation in these studies has the potential to markedly reduce trial costs and speed enrollment. In the near future, we will take the next step and introduce the test into EU clinics for use as a diagnostic tool, as is already occurring in the U.S., with California becoming the latest addition.
“Alzheimer’s disease is a debilitating neurological disorder that respects no boundaries — we understand the interest across Europe as well as Asia and around the world in this development. We are committed to responding to this interest in meaningful ways.”
The nonprofit Alzheimer Europe states that informing people that they have a dementia diagnosis at a sufficiently early stage “helps them to make sense of what they have been experiencing” and may enable them to “express their autonomy, understand changes within themselves, prepare themselves spiritually” and positively influence their lives in other ways.
Arnaud Bernaert, Head of Health and Healthcare, and Member of the Executive Committee of the World Economic Forum says, “Alzheimer’s disease creates a human toll that we are unable to fully calculate; it burdens patients, their families and entire communities around the world. It’s essential that we empower scientists and doctors in their commitment to developing diagnostic tools that can aid patients when they are struggling with memory challenges. I congratulate C2N Diagnostics on the launch of PrecivityAD. This is a remarkable step forward in the field that will help the fight against this horrible disease.”
PrecivityAD™ Identifies Brain Amyloid Plaque Status
Based on data from 686 patients older than 60 with subjective cognitive impairment or dementia, the PrecivityAD™ test correctly identified brain amyloid plaque status (as determined by quantitative amyloid PET scans) in 86% of the patients. The Receiver Operating Characteristic (ROC) for the analysis had an area under the curve (AUC) of 0.88. Further details of the test’s diagnostic performance are provided here.
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 new tool for physicians to aid in the evaluation process.
The PrecivityAD™ test does not involve any radiation and is non-invasive. These features are expected to 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.
Knowing that a patient’s symptoms are due to Alzheimer’s disease can help inform a physician to prescribe specific Alzheimer’s disease treatments or lifestyle interventions in order to aid in the management of the disease. A study of patients adopting healthy lifestyle behaviors found a dramatic reduction in risk of dementia, between 37% and ~60%, depending on intensity of the behavioral changes.
C2N continues to pursue the requisite certificates that will permit the PrecivityAD™ test to be available in Maryland, Pennsylvania, Rhode Island, and New York, which require individual state processes for CLIA labs.
Development of the PrecivityAD™ blood test has been funded partially by the National Institutes of Health, GHR Foundation, Alzheimer’s Drug Discovery Foundation, and BrightFocus Foundation.
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.