C2N Diagnostics Releases the PrecivityAD2™ Blood Test for Clinical Care, a Robust Assay with High Concordance to Amyloid PET and CSF

PrecivityAD2 Aims to Set a New Performance Standard for Blood Biomarkers in Alzheimer’s Disease Diagnosis With Combined Measures of Amyloid Beta (Aβ42/40) and Tau Protein (p-tau217/np-tau217) Ratios

Precivity AD2 is Expected to Serve Major Unmet Need for an Accurate and Accessible Test Given the Availability of New Disease Modifying Therapies

With Expanded Test Portfolio, C₂N Also Introduces Enhanced Phlebotomy Services to Include Over 700 Patient Service Centers and 13,000 Mobile Phlebotomists Across the United States

ST. LOUIS--(BUSINESS WIRE)--#Alzheimers--C₂N Diagnostics, a leader in advanced brain health diagnostics, today announced the release of the PrecivityAD2 blood test, 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 (AD) and other causes of cognitive decline.

The PrecivityAD2 test is an analytically and clinically validated blood test that aids healthcare providers in ruling in or ruling out AD in patients presenting with mild cognitive impairment or dementia. In a clinical validation study involving two independent cohorts totaling 583 patients with cognitive impairment using amyloid PET as the reference standard, the PrecivityAD2 blood test achieved an overall test performance statistic of 0.94 AUC and 88% accuracy.

The PrecivityAD2 blood test simultaneously quantifies specific plasma amyloid beta and tau peptide concentrations to calculate the Aβ42/40 Ratio and p-tau217/np-tau217(p-tau217 Ratio). The inclusion of plasma analyte ratios using the company’s proprietary mass spectrometry methods has been shown to improve test robustness and help mitigate the effects of confounding factors such as chronic kidney disease and cardiovascular disease. The ratios are combined into a proprietary statistical algorithm to calculate the Amyloid Probability Score 2 (APS2), a numerical value ranging from 0–100, that determines whether a patient is Positive (has high likelihood) or Negative (has low likelihood) for the presence of brain amyloid plaques by amyloid PET scan.

In addition, the PrecivityAD2 blood test is bolstered by research from Dr. Sebastian Palmqvist and his colleagues at Lund University in Sweden with the BioFINDER-Primary Care and Memory Care studies that involved over 1,000 patients with cognitive concerns from four independent cohorts. His recent research presented at the 2023 Alzheimer’s Association International Conference outlined that this blood test had very high accuracy (AUC 0.95-0.97) for identifying Alzheimer’s disease pathology, primarily using CSF biomarkers as the reference standard.

Dr. Demetrius Maraganore, FAAN, and the Herbert J. Harvey, Jr. Chair of Neurology at the Tulane University School of Medicine, says, “My passion is helping patients to achieve successful brain aging by preventing and reducing the burden of cognitive decline and dementia. In this regard, the PrecivityAD2 blood test makes a significant contribution to the diagnosis of patients with Alzheimer’s disease. It is a convenient and accurate alternative to PET scans and cerebrospinal fluid tests, which are limited in availability. I intend to use PrecivityAD2 in my practice to determine my patients’ eligibility for newly approved Alzheimer’s disease therapies.”

Precivity™ Line of Blood Tests Expands Further With Availability of Precivity-ApoE™ Test

C₂N’s PrecivityAD2 blood test joins the company’s Precivity-ApoE blood test, which is indicated for use in adult patients for whom knowledge of apolipoprotein E2, E3, E4 allele status may be informative for medical management and treatment decisions. C₂N launched its original PrecivityAD® blood test to wide acclaim nearly three years ago. The company says the entire test portfolio facilitates earlier and more accurate diagnosis of Alzheimer’s disease pathology by healthcare providers.

“We believe the PrecivityAD2 test represents the next generation in blood biomarker tests and will help establish a new standard in Alzheimer’s disease diagnosis. The 2022 Clinical Trials on Alzheimer’s Disease Task Force report outlined that combined biomarkers can be especially helpful in avoiding misdiagnosis, and PrecivityAD2 does just that by harnessing two established biomarkers in one assay. We believe the test addresses a major unmet need for an accurate, safe, non-invasive, and accessible alternative to amyloid PET scans and lumbar punctures,” says Dr. Joel Braunstein, C₂N’s president and CEO. “This announcement is timely with the approval of new disease modifying therapies and others on the way along with the ability for healthcare providers to more easily refer patients to sites or to mobile phlebotomists where their blood can be drawn for diagnosis.”

Both the PrecivityAD2 and 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. The Precivity-ApoE Test is intended for use in adult patients for whom the test result may be informative for medical management and treatment decisions. The tests are available in every state (except New York) and Washington, D.C., and Puerto Rico.

All Precivity tests must be ordered by an authorized healthcare provider, and patients can easily schedule a blood draw appointment from C₂N’s network of over 700 patient service centers and 13,000 mobile phlebotomists.

The C₂N laboratory is a CLIA-certified, CAP-accredited laboratory that performs the Precivity tests as Laboratory Development Tests (LDT). C₂N received a Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018. C₂N is the preferred diagnostics provider by over 20 leading biopharmaceutical companies.

Healthcare providers may order the Precivity tests by calling 1-877-226-3424 or visiting www.precivityAD.com.

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 15,000 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.

COMPANY CONTACT:
Joni Henderson
JHenderson@c2n.com
314-464-0009

MEDIA CONTACT:
Adam Shapiro
Adam.Shapiro@ASPR.bz
202-427-3603