JAMA Published Landmark Clinical Study on Alzheimer’s Disease Diagnosis Using the PrecivityAD2™ Blood Test
JAMA Published Landmark Clinical Study Showing C2N Diagnostics’ PrecivityAD2™ Blood Test Markedly Improves Accuracy of Alzheimer’s Disease Diagnosis in Both Primary Care and Specialized Memory Care
The Journal of the American Medical Association (JAMA) published a large clinical study examining the ability of C2N’s PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in both specialized memory care and the primary care setting, to which most patients with cognitive concerns turn for initial answers about their memory loss. The study found the same levels of strong performance and robustness for the PrecivityAD2™ test in patients regardless of where they presented for their initial care. The PrecivityAD2™ test delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis.
The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also stated that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and specialized memory care.
The media took notice of this important news and shared it with the public in a way that attracted enormous attention:
New Partnerships
C2N Diagnostics and Unilabs Announce Global Partnership, Bringing Together Innovation Leaders in Diagnostics and Laboratory Medicine to Advance Brain Health
C2N announced a major milestone in brain health diagnostics and research across Europe and beyond with Unilabs, a leading international provider of diagnostic services.
The partnership expands the reach of C2N’s Precivity™ blood tests in over 75 countries to help transform the early diagnosis of and the research in Alzheimer’s disease. The agreement also includes plans to facilitate a technology transfer of C2N’s proprietary portfolio of Alzheimer’s blood biomarkers to deliver a Unilabs testing network across Europe.
C2N’s Precivity™ Tests are Now Offered Through Mayo Clinic Laboratories
C2N Diagnostics has entered into a non-exclusive agreement with Mayo Clinic Laboratories, for inclusion of C2N’s Precivity™ tests in Mayo Clinic Laboratories’ test offerings to its clients.
William G. Morice II, M.D., Ph.D., President & CEO, Mayo Clinic Laboratories says, “By offering C2N’s tests to our clients, they have access to a portfolio of Alzheimer’s disease tests to ensure their patients receive the right answers when they need them most.”
Dr. Joel Braunstein, C2N’s CEO, says, “While C2N Diagnostics continues expanding its own commercial, operational and IT infrastructure in the U.S. and strategic countries, we’re extremely pleased to work with Mayo Clinic Laboratories to broaden access to Precivity™ testing through Mayo Clinic Laboratories’ global distribution channels, extensive U.S. infrastructure, and EMR connectivity. This non-exclusive partnership with Mayo Clinic Laboratories builds on our exclusive partnerships in other select markets. Overall, it demonstrates our commitment to excellence in clinical care and to collaborating with premium diagnostics leaders to make high-performance Alzheimer’s disease tests more accessible to healthcare providers and patients around the world. We look forward to elevating the quality of care for many patients in clinical need.”
Upcoming Webinars
A New Paradigm in the Detection of Amyloid Pathology: The Emergence of Highly Accurate Blood Tests, Upcoming Webinar Hosted by Xtalks
Join Joel Braunstein, MD, MBA, CEO and Co-Founder of C2N Diagnostics and Gil Rabinovici, MD, PhD, Professor, Department of Neurology, Memory & Aging Center, UCSF on Wednesday, September 4th at Noon EDT for this free webinar.
Attendees will gain insights from the Imaging Dementia – Evidence of Amyloid Scanning (IDEAS) study, which examines the real-world performance and utility of amyloid positron emission tomography (PET) scans in a prospective clinical care study involving Medicare beneficiaries with cognitive impairment.
In addition, attendees will learn about the PrecivityAD2™ blood test performance compared to PET scans and cerebrospinal fluid (CSF) tests for the evaluation of amyloid pathology in patients presenting with signs or symptoms of mild cognitive impairment or dementia.
The speakers will discuss the importance of pathological biomarker ratios in mitigating differences in quantitative measurements related to age, sex, ethnicity, race, and comorbidities.
Diagnostic Challenges and Opportunities in Alzheimer’s Disease Management, Webinar hosted by NAMCP (National Association of Managed Care Physicians)
Join Ian N. Kremer, JD, Executive Director, LEAD (Leaders Engaged on Alzheimer's Disease) Coalition, Suzanne E. Schindler, MD, PhD, Associate Professor of Neurology Washington University School of Medicine, Joel Braunstein, MD, MBA, CEO and Co-Founder, C2N Diagnostics, LLC, and Moderator: Gary M. Owens, MD, Gary Owens Associates, Inc on Tuesday September 17, 2024, 12:00 – 1:00pm EST for this free live webinar.
Approximately 16 million Americans are living with mild cognitive impairment and dementia and warrant a diagnostic evaluation to determine the cause of their cognitive decline. The prevalence of Alzheimer’s disease (AD) as a cause of cognitive decline in this population ranges from 30-60%.
Accurate and expeditious detection of AD pathology in affected patients continues to be a significant hurdle to delivering optimal care for patients with signs and symptoms of cognitive decline. There is an urgent unmet need for safe, lower cost, less resource-intensive, easily accessible, and broadly available tests that identify the presence or absence of brain amyloid plaques, a pathological hallmark of AD. This need has become even more prominent with the recent FDA approval of two disease-modifying therapies for AD. Current care may be improved using high performing blood biomarkers to potentially shorten the diagnostic journey and facilitate the early treatment of Alzheimer's disease.
This live webinar presentation of Diagnostic Challenges and Opportunities in Alzheimer’s Disease Management will take a close look at Alzheimer’s disease blood biomarker tests, as the emerging options and best practices to help health care providers have broad implications for managed care professionals.
Ask the Expert
Dr. Sheena Aurora serves as C2N’s Vice President of Neurology and is an experienced and passionate medical industry executive. She’s board-certified in neurology and has 30 years of clinical practice that provides her with unique and relevant insights into all phases of product development, commercialization, and business development.
Dr. Aurora is proud that she’s been voted on “top doctor” lists numerous times in Seattle and the San Francisco Bay Area. In 2021, she was recognized as one of the top 20 women leaders in the biopharmaceutical research and development sector.
She also continues her position as an Adjunct Clinical Associate Professor at Stanford University.
Please describe your role as Vice President of Neurology.
I lead clinical and medical affairs for C2N, which is focused on the safety and efficacy of our diagnostic products and services. My perspective and experience is based on three decades of clinical experience. This background enhances my ability to translate our science to healthcare providers, payers, patients and their caregivers.
I believe my role is as an emissary to transfer the scientific acumen that can then be utilized to help with streamlining the diagnosis of Alzheimer's disease.
You’ve served in important roles in the U.S. and globally. What differences exist between the U.S. and global markets, and how is C2N navigating them?
I’ve had the opportunity to participate in global product launches within the healthcare sector. In my experience, the most successful launches leveraged tactics that were aimed for success in the U.S. and then were able to grow with global implementation. For example, scientific exchanges are allowed outside the U.S., and we were able to utilize continuing medical education material to transfer the scientific acumen. C2N has established an incredible network of collaborators that span the globe. This enables us to gain important scientific insights into Alzheimer’s disease epidemiology and approaches to clinical care across different markets. We try to leverage these learnings into better products and services for the clinicians we partner with and their patients.
What do you see in the future for C2N and the Precivity tests?
The future promise of our science at C2N is very bright. C2N is continuing to innovate new tools and services that we believe will be impactful for both patient care and clinical research. This includes novel assays, like MTBR-tau, that will help us understand much more about neurofibrillary (tau) tangles, one of the core neuro-pathologies of Alzheimer’s disease, and how they are important in both diagnosis and treatment strategies. I think we also greatly benefit from the Journal of the American Medical Association’s decision to publish a large clinical study examining the ability of the PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in both specialized memory care and primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. These studies are vitally important to demonstrating to healthcare providers and policymakers the high performance of our blood biomarkers and how they can help to shape new standards of clinical care.
Connect With C2N
Upcoming Presentations
Dr. Joel Braunstein will present at:
CEOi Lausanne XI Conference
October 1-3
ADDF Fourteenth Annual Fall Symposium & Luncheon
November 7
New York, NY
NEWDIGS Roundtable: Potential patient access to pre-symptomatic/early-stage Alzheimer’s care
November 14
Boston, MA
Upcoming Conferences
CTAD: Clinical Trials on Alzheimer’s Disease
Oct. 29-Nov. 1
Madrid, Spain
NAMCP: National Association of Managed Care Physicians
Nov. 7 – 8
Las Vegas, NV
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 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. For more information visit www.C2N.com.