C2N Diagnostics, a recognized global leader in advanced brain health diagnostics, has taken an important step forward in the fight against Alzheimer’s disease. The company has formally submitted its innovative blood test to the U.S. Food and Drug Administration (FDA) for regulatory review a milestone that could transform how clinicians detect one of the most devastating neurodegenerative disorders of our time.
The test is designed to detect brain amyloid pathology, a defining hallmark of Alzheimer’s disease, using a simple blood draw. This submission is significant not only for the Alzheimer’s community but also for the entire field of diagnostics, as it marks what C2N believes to be the first multi-analyte, algorithmic blood test based on high-resolution mass spectrometry (HRMS) ever submitted for FDA review.
A Breakthrough in Diagnostic Science
For decades, Alzheimer’s diagnosis has relied heavily on invasive or expensive procedures, such as lumbar punctures for cerebrospinal fluid (CSF) analysis or positron emission tomography (PET) scans. While accurate, these options are not always practical, affordable, or widely accessible. Blood-based diagnostics, however, have the potential to dramatically expand access to accurate testing, bringing earlier answers to millions of people worldwide.
C2N’s blood test leverages the power of HRMS, a cutting-edge technology that can detect circulating proteins in blood with extraordinary sensitivity and specificity. Specifically, the test quantifies multiple plasma biomarkers — different isoforms of β-amyloid and tau peptides — that are central to Alzheimer’s disease pathology.
Key biomarkers include:
- Aβ42/40 ratio – an established marker of amyloid plaque burden in the brain.
- p-tau217/np-tau217 ratio (%p-tau217) – a measure of phosphorylated tau, another hallmark of disease progression.
These values are fed into a proprietary statistical algorithm that produces a score between 0 and 100. Clinicians can then interpret this score to assess the likelihood that a patient has brain amyloid pathology consistent with Alzheimer’s disease.
By combining multiple biomarkers in one test, C2N provides a higher level of diagnostic accuracy than any single measure alone, representing a true leap forward for molecular diagnostics and precision medicine.
Building on Proven Success
This submission is not C2N’s first step into the Alzheimer’s diagnostic space. The company already markets the Precivity™ line of blood tests, which are designed for patients aged 50 and older who exhibit signs of mild cognitive impairment or dementia. These tests provide critical insights that can guide medical management, treatment decisions, and patient counseling.
- The PrecivityAD® test, first launched several years ago, was the first widely accessible Alzheimer’s blood test, marking the beginning of a new era in non-invasive diagnostics.
- The PrecivityAD2™ test, a more advanced version, demonstrated remarkable accuracy in identifying amyloid pathology.
A landmark study published in the Journal of the American Medical Association (JAMA) confirmed the test’s clinical value. It showed that PrecivityAD2 significantly improved diagnostic accuracy in both primary care settings — where many patients first present with memory complaints — and in specialty memory clinics. At a predefined binary cutoff, the test achieved over 90% accuracy compared to gold-standard CSF and amyloid PET testing.
These studies highlight how C2N’s approach can be seamlessly integrated into routine clinical care, giving physicians powerful, evidence-based tools without relying exclusively on specialized facilities.
Global Standards and Quality
C2N operates under the ISO 13485:2016 certification, reflecting compliance with international quality standards for medical devices. The company also conducts testing in its CAP-accredited and CLIA-certified laboratory in St. Louis, ensuring that every result meets rigorous scientific and regulatory benchmarks.
Such infrastructure not only establishes trust in C2N’s tests but also sets the stage for scaling access to patients across the U.S. and beyond.
The Importance of FDA Review
Dr. Joel Braunstein, CEO and President of C2N Diagnostics, described the FDA submission as a defining moment:
“The FDA review is an important moment for our company, the entire Alzheimer’s disease community, the field of molecular diagnostics, and precision medicine. Our FDA filing reflects our evidence-based approach and commitment to scientific breakthroughs that translate to clinical care solutions intended to improve patients’ lives.”
The FDA had already recognized the importance of C2N’s work back in 2018, granting the company a Breakthrough Device designation. This designation is reserved for technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, expediting the agency’s assessment and review.
This latest submission moves C2N closer to potentially offering an FDA-cleared blood test that could become part of routine clinical practice for millions of patients at risk of Alzheimer’s disease.
Expert Perspectives
The Alzheimer’s Drug Discovery Foundation (ADDF), a leading nonprofit driving innovation in the field, praised C2N’s achievement. Dr. Howard Fillit, co-founder and Chief Science Officer at ADDF, commented:
“We eagerly await the FDA’s review of the C2N blood test. For healthcare professionals, blood tests are invaluable tools to help rule Alzheimer’s disease in or out. We believe C2N’s tests to be accurate and actionable, reflecting the incredible progress we’ve made in the biomarkers space. Tools like these will be crucial to enabling precision medicine for Alzheimer’s. This submission is important news for the field and for the ADDF’s mission to rapidly accelerate the development of drugs to prevent, treat, and cure Alzheimer’s disease.”
Such endorsements highlight how blood-based diagnostics could complement — and in some cases replace — more invasive or expensive procedures, broadening access to critical information and advancing patient care.
A Turning Point for Patients and the Industry
For patients and families grappling with cognitive decline, timely and accurate diagnosis can make an enormous difference. Alzheimer’s is currently incurable, but early detection opens the door to better care planning, access to new therapies, and the ability to participate in clinical trials.
C2N’s submission also carries implications for the broader diagnostics industry. By successfully integrating multi-analyte algorithms with HRMS in a clinically validated product, the company is paving the way for future tests targeting other complex diseases where multiple biomarkers must be analyzed simultaneously.
In essence, this milestone signals not just a step forward in Alzheimer’s diagnostics but a paradigm shift in laboratory medicine.
Looking Ahead
As the FDA review process begins, the Alzheimer’s community, medical professionals, and biotech industry will be closely watching the outcome. Should the test receive clearance, it could set a new standard for how neurodegenerative diseases are evaluated in clinical practice.
C2N remains committed to expanding its portfolio of brain health diagnostics, with the long-term vision of enabling precision medicine approaches to neurological disorders on a global scale.
For now, the company’s submission stands as a beacon of hope: a scientifically rigorous, clinically validated, and potentially transformative tool that could change how Alzheimer’s disease is detected and managed.
About C2N Diagnostics, LLC
C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions 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 assays have been used in over 150 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 in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, Mayo Clinic Laboratories, and Unilabs. Over 50,000 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, Alzheimer’s Association, and The Michael J. Fox Foundation. For more information visit www.c2n.com.
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