Company Sees the Soon-to-be-Released PrecivityAD2™ Blood Test as Reliable Replacement for CSF and PET as Alzheimer’s Disease Diagnosis Guideline Updating Begins

C₂N Diagnostics says it further bolstered its role as a leader in advanced brain health diagnostics at the Alzheimer’s Association International Conference^® (AAIC^®) 2023 in Amsterdam. The presentations included information on the company’s pipeline product, PrecivityAD2, along with other Precivity-related analytes that are setting a new standard in blood biomarker innovation and diagnostic performance. The company’s next generation product, PrecivityAD2, with a commercial release this month, is designed to help healthcare providers determine the presence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease (AD), by using proprietary mass spectrometry technology.

Several highlights of the research discussed at AAIC included the following:

• Dr. Sebastian Palmqvist of Lund University in Sweden explained first-of-its-kind data, involving over 1,000 patients with cognitive concerns from four independent cohorts, about the use of the PrecivityAD2 blood test in primary care. The PrecivityAD2 test 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. Dr. Palmqvist and his colleagues with the BioFINDER-Primary Care study say the blood test had both very high accuracy for identifying Alzheimer’s disease pathology (AUCs 0.95-0.97) and for helping to correctly diagnose clinical Alzheimer’s disease in up to 87% of the cases as compared to primary care physicians using standard assessment tools (55% of the cases).

“We’ve shown that primary care doctors could gain access to a blood biomarker test with high test performance to detect Alzheimer’s disease pathology. This high performance means that these tests may be used to identify AD pathology with the same accuracy as the current cerebrospinal fluid biomarkers, known as a spinal tap, that we currently rely on. These tests could raise quality of care to a new standard for many patients, but before implementation in primary care there are several important aspects that need to be considered, such as whom to test and what to do with a positive/negative test result,” says Dr. Palmqvist.

• Dr. Suzanne Schindler of Washington University School of Medicine in St. Louis added to the growing data of high-performance blood tests based on C₂N’s underlying technology to evaluate patients presenting with cognitive impairment. Her analysis (performed in the laboratory of C₂N co-founder Dr. Randall Bateman) on over 1,500 individuals from two independent cohort studies found that the plasma p-tau217 ratio that the company measures to be equivalent in performance to identify amyloid and even better for clinical use as compared to two FDA-cleared CSF amyloid tests.

• Eli Lilly and Company used C₂N’s Precivity-p-tau217 blood biomarker in its Phase 3 clinical trial and analysis for donanemab, which Lilly says significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease. Exploratory outcomes included changes in plasma p-tau217 at 76 weeks and other time-based analyses.

These developments occur as the National Institute on Aging and the Alzheimer’s Association look to update their diagnostic criteria to incorporate blood biomarkers for the first time so healthcare providers can use them to identify amyloid plaques in the brain, a hallmark indicator of Alzheimer’s disease. The workgroup is currently collecting feedback and suggestions about the draft guidelines.

C₂N CEO Dr. Joel Braunstein noted that the developments at AAIC occur along with the fact that Eisai Co., Ltd. used C₂N’s assay in its clinical trial for the recently approved LEQEMBI® for Alzheimer’s disease treatment. “These activities demonstrate C₂N’s blood biomarkers have been principal blood biomarkers to demonstrate biological evidence of clinically-relevant disease modification with anti-amyloid therapeutic antibodies. This positioning will continue to grow and be very helpful as diagnostic guidelines reflect these innovations and recognize their availability for use in clinical care. It’s a privilege for our biomarkers to be incorporated into landmark treatment studies that are changing how patients with early AD will be managed. We believe these data, combined with the primary care data presented by Dr. Palmqvist, further bolster the company’s position as the preferred partner in brain health diagnostics to work alongside healthcare providers in improving patient care and to advance clinical research of new treatment options for patients.”

Dr. Braunstein also affirmed the company’s commitment to the trifecta required by the EU/US CTAD Task Force guidelines for the development of effective blood biomarkers in real world studies, which are high performance, prespecified cut-off points, and prospective trial designs.

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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