C2N Diagnostics and SouthGenetics Partner to Expand Access to Alzheimer’s Blood Biomarker Testing Across Latin America and the Caribbean
C2N Diagnostics, LLC, a specialty diagnostics company focused on advancing blood-based biomarker testing for neurodegenerative diseases, has announced a strategic collaboration with SouthGenetics, a U.S.-based diagnostics organization with extensive experience introducing molecular and precision medicine technologies across Latin America and the Caribbean. The partnership is designed to expand access to C2N’s Precivity® portfolio of blood tests, which provide clinically relevant information related to amyloid pathology associated with Alzheimer’s disease.
The collaboration represents an important step toward improving diagnostic access in regions where healthcare systems face increasing demand for dementia care services, limited specialist availability, and restricted access to advanced imaging technologies such as amyloid PET scans.
Through this initiative, healthcare professionals in several Latin American and Caribbean countries will gain access to C2N’s blood-based diagnostic tools designed to support the detection of amyloid plaques in the brain, a key pathological hallmark of Alzheimer’s disease. These tests are intended to assist clinicians in evaluating patients with cognitive impairment and inform more precise medical management and treatment decisions.
Expanding Alzheimer’s Diagnostics in Underserved Regions
The initial rollout of the collaboration will focus on several countries across the region, including Argentina, Chile, Colombia, the Dominican Republic, Ecuador, Jamaica, Mexico, Uruguay, and Venezuela. Additional countries are expected to be evaluated for future expansion as implementation progresses.
The need for scalable and accessible Alzheimer’s disease diagnostics is growing rapidly in Latin America and the Caribbean. Population aging trends are driving a significant increase in the number of individuals at risk for dementia-related conditions, while healthcare infrastructure in many regions remains under-resourced in terms of specialized neurological care.
Access to advanced diagnostic tools such as positron emission tomography (PET) imaging, which can detect amyloid plaque buildup in the brain, is limited in many healthcare systems due to high costs, technical complexity, and lack of widespread availability.
At the same time, the introduction of disease-modifying therapies for Alzheimer’s disease in select global markets has increased the urgency for accurate and accessible diagnostic solutions that can identify patients who may benefit from treatment.
Against this backdrop, blood-based biomarker testing is emerging as a practical and scalable alternative that can help bridge diagnostic gaps and support earlier and more accurate identification of Alzheimer’s pathology.
The Precivity® Blood Test Portfolio
At the center of the collaboration is C2N Diagnostics’ Precivity® portfolio of blood-based tests, which are designed to measure biomarkers associated with amyloid accumulation in the brain.
Amyloid plaques are widely recognized as one of the defining pathological features of Alzheimer’s disease and are closely linked to disease progression. Detecting their presence can play a critical role in confirming diagnosis and guiding clinical decision-making.
The Precivity® tests are intended to provide healthcare professionals with noninvasive insights into amyloid pathology using a simple blood draw. These tests are not designed to replace clinical evaluation but to complement existing diagnostic approaches by providing additional biological information that can improve diagnostic confidence.
According to C2N Diagnostics, the availability of such tools in regions with limited access to specialized imaging and neurology expertise could significantly improve the quality and consistency of dementia care.
Leadership Perspectives on the Collaboration
Dr. Joel Braunstein, President and Chief Executive Officer of C2N Diagnostics, emphasized that the Precivity® platform was developed to provide clinicians with clearer, scientifically grounded insights into Alzheimer’s disease pathology.
He noted that the collaboration with SouthGenetics represents a meaningful step toward expanding access to advanced blood biomarker testing in healthcare systems that are preparing for increased demand in Alzheimer’s disease diagnosis and treatment.
Dr. Braunstein highlighted that the partnership aligns with C2N’s broader mission of delivering “Clarity Through Innovation®” by making complex biological information more accessible to clinicians worldwide.
From SouthGenetics’ perspective, CEO Washington Rodriguez emphasized that successful implementation of advanced diagnostic technologies in the region depends not only on scientific innovation but also on effective healthcare system integration.
He explained that SouthGenetics was established to address the gap between innovation and real-world implementation by providing logistical support, medical education, and country-specific deployment strategies. According to Rodriguez, ensuring that healthcare providers can effectively access and utilize these tools is essential for improving patient outcomes in regions with diverse healthcare infrastructures.
Supporting Regional Healthcare Infrastructure
SouthGenetics will play a central role in operationalizing the collaboration across Latin America and the Caribbean. The company will leverage its established network of commercial operations, medical engagement teams, and logistics systems to support test availability and physician adoption.
Key responsibilities will include facilitating physician education, coordinating sample collection and transport, and establishing access pathways for patients undergoing evaluation for cognitive decline or suspected dementia.
Importantly, access to the Precivity® tests will be limited to qualified healthcare professionals and used as part of a broader clinical assessment process.
This implementation strategy is intended to ensure that blood-based biomarker testing is integrated appropriately into existing diagnostic workflows while maintaining clinical rigor and data quality standards.
Evidence Supporting Blood-Based Alzheimer’s Diagnostics
The collaboration is supported by a growing body of clinical evidence validating the performance of C2N’s blood-based Alzheimer’s diagnostics.
C2N’s earlier PrecivityAD® test was included in the Davos Alzheimer’s Collaborative Healthcare System Preparedness Early Detection Flagship Program, which implemented digital cognitive assessments and blood biomarker testing across multiple international sites, including locations in Mexico and Brazil.
Results from that program demonstrated that blood-based biomarker testing, when combined with cognitive assessment tools, improved clinician confidence in diagnosing and managing cognitive impairment in both primary care and non-specialist settings. These findings underscore the potential value of scalable diagnostic tools in regions where access to dementia specialists and advanced imaging remains limited.
More recent research has further strengthened the clinical validity of C2N’s next-generation assay, PrecivityAD2®.
A large-scale clinical study published in JAMA evaluated a blood test based on plasma p-tau217 and the Aβ42/Aβ40 ratio in more than 1,200 patients undergoing cognitive evaluation. The study found that the blood-based approach demonstrated high diagnostic accuracy for identifying Alzheimer’s disease pathology and, in many cases, outperformed standard clinical evaluations conducted by both primary care physicians and dementia specialists.
Additional validation published in npj Dementia further confirmed the accuracy of the PrecivityAD2® test when compared with amyloid PET imaging. The study reported strong sensitivity and specificity using clinically established thresholds, reinforcing the reliability of blood-based biomarker approaches as an alternative to more resource-intensive imaging methods.
Regulatory Recognition and Ongoing Development
C2N Diagnostics’ technology has also received regulatory recognition in multiple regions.
The company’s proprietary brain amyloidosis blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), reflecting its potential to address significant unmet medical needs in Alzheimer’s disease diagnostics. The test is currently under FDA review.
In addition, the PrecivityAD2® test received medical device registration from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2025, further supporting its international clinical adoption.
These regulatory milestones reinforce growing global interest in blood-based biomarkers as a transformative approach to diagnosing neurodegenerative diseases.
Addressing the Growing Burden of Dementia
Alzheimer’s disease represents one of the most significant and rapidly growing public health challenges worldwide. As populations age, particularly in regions such as Latin America and the Caribbean, the number of individuals affected by cognitive decline and dementia is expected to rise substantially.
Healthcare systems in many of these countries face structural challenges, including limited access to neurologists, uneven distribution of diagnostic infrastructure, and financial barriers to advanced imaging technologies.
In this context, blood-based diagnostic tools offer a potentially scalable and cost-effective solution that can help expand diagnostic capacity and enable earlier intervention.
By improving diagnostic accuracy and accessibility, tools like the Precivity® portfolio may help healthcare systems better identify patients who could benefit from emerging disease-modifying therapies, once clinically appropriate.
The collaboration between C2N Diagnostics and SouthGenetics represents a significant step toward expanding equitable access to Alzheimer’s disease diagnostics in underserved regions.
As implementation progresses, both organizations aim to strengthen physician education, expand infrastructure for sample handling and testing, and support the integration of blood-based biomarkers into routine clinical practice.
While the Precivity® tests are intended to be used alongside clinical evaluation and not as standalone diagnostic tools, their growing validation and accessibility position them as an important addition to the global Alzheimer’s diagnostic toolkit.
By combining advanced molecular diagnostics with established regional distribution and healthcare implementation expertise, the partnership seeks to help bridge the diagnostic gap for Alzheimer’s disease across Latin America and the Caribbean, ultimately supporting earlier and more accurate patient care decisions.
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 200 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, and Mayo Clinic Laboratories. Over 90,000 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.
About SouthGenetics
SouthGenetics has an international presence with more than 20 years of experience in Latin America and the Caribbean. The company focuses on expanding access to advanced diagnostic tools for patients and health care professionals across the region.
SouthGenetics has introduced multiple pioneering diagnostic innovations in Latin America, including prenatal fetal DNA testing, liquid biopsy technologies, and advanced biomarkers in urology and oncology. The company partners with leading international laboratories in molecular diagnostics and precision medicine, helping bridge the gap between global innovation and regional access.
