Alzheimer's Blood Tests Now Reaching Latin America and the Caribbean
C2N Diagnostics partners with SouthGenetics to bring FDA-recognized Alzheimer's blood tests to 9 Latin American and Caribbean nations.
Summary
C2N Diagnostics is expanding access to its PrecivityAD2 blood tests for Alzheimer's disease assessment across Latin America and the Caribbean through a new partnership with SouthGenetics. The tests detect brain amyloid pathology from a blood sample, offering an alternative to costly PET imaging that is scarce in many of these regions. Initially targeting nine countries including Mexico, Colombia, and Argentina, the collaboration aims to support earlier diagnosis and guide treatment decisions — especially important now that disease-modifying Alzheimer's therapies have received recent regulatory approvals. The PrecivityAD2 test has been validated in large clinical studies published in JAMA and npj Dementia and holds FDA Breakthrough Device designation, lending it significant credibility as a clinical tool.
Detailed Summary
Access to early Alzheimer's detection is a critical gap in global healthcare, and blood-based biomarker tests represent one of the most promising solutions. C2N Diagnostics has announced a partnership with SouthGenetics to bring its Precivity portfolio of Alzheimer's blood tests to Latin America and the Caribbean — a region facing rapidly aging populations, limited dementia specialist capacity, and insufficient PET imaging infrastructure.
The centerpiece of the expansion is the PrecivityAD2 test, which measures biomarkers related to brain amyloid pathology directly from a blood draw. This is significant because amyloid accumulation is a hallmark of Alzheimer's disease, and identifying it early can inform both clinical evaluation and eligibility for emerging disease-modifying therapies. Until recently, amyloid assessment required expensive and logistically demanding PET brain scans, largely inaccessible in lower-resource settings.
The test carries substantial scientific backing. Its diagnostic accuracy has been evaluated in a large clinical study published in JAMA and independently validated in npj Dementia. It has also received FDA Breakthrough Device designation and was registered with the UK's MHRA in 2025 — markers of regulatory confidence in its clinical utility.
SouthGenetics will manage regional rollout through its existing commercial, medical, and logistics infrastructure across nine initial countries: Argentina, Chile, Colombia, Dominican Republic, Ecuador, Jamaica, Mexico, Uruguay, and Venezuela. The partnership is designed to support physician education, sample logistics, and access pathways for qualified healthcare professionals.
There are important caveats. Precivity tests are not standalone diagnostic tools and must be used within a broader clinical evaluation. Expanding laboratory infrastructure and ensuring equitable physician access across diverse healthcare systems will take time. Nonetheless, this initiative reflects the growing global momentum around blood-based Alzheimer's biomarkers as practical, scalable tools for early detection and treatment guidance.
Key Findings
- PrecivityAD2 detects brain amyloid from a blood draw, replacing the need for costly PET imaging in many cases.
- Test validated in a large JAMA study and independently confirmed in npj Dementia, supporting strong diagnostic accuracy.
- FDA Breakthrough Device designation and MHRA registration in 2025 signal strong regulatory confidence.
- Expansion targets 9 countries with aging populations and limited dementia specialist access.
- Rollout is timed with recent approvals of disease-modifying Alzheimer's therapies, enabling earlier treatment decisions.
Methodology
This is a news report summarizing a commercial partnership announcement from C2N Diagnostics and SouthGenetics. It references peer-reviewed validation studies published in JAMA and npj Dementia, and cites regulatory designations. No original primary research data is presented directly.
Study Limitations
The article is a press release-style news summary and does not provide detailed methodology or raw data from referenced studies. The Precivity tests are not standalone diagnostic tools and require qualified clinical interpretation. Real-world implementation timelines, cost accessibility, and reimbursement pathways across the nine targeted countries are not addressed.
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