C2N Diagnostics, a provider of advanced brain health diagnostics, has released 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 Sebastian Palmqvist, MD, PhD, 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.

Demetrius Maraganore, MD, 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 Blood Test Adds to Diagnostic Family

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 Joel Braunstein, MD, 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.