C2N Diagnostics and SouthGenetics Partner to Enable Broader Access to Precivity® Blood Tests for Alzheimer’s Disease Assessment in Latin America, Caribbean

Key Takeaways

• C2N and SouthGenetics launch Precivity blood tests in 9 Latin American countries
• Tests detect amyloid plaques, aiding early Alzheimer’s diagnosis without PET scans
• Partnership leverages SouthGenetics’ logistics to overcome regional specialist shortages
• PrecivityAD2 received FDA Breakthrough Device designation, boosting market credibility
• Early detection supports new disease‑modifying therapies approved in the region

Pulse Analysis

Latin America and the Caribbean are confronting a rapid demographic shift, with the proportion of adults over 65 projected to double by 2050. This aging wave is straining health systems that already lack sufficient dementia specialists and PET imaging facilities, the gold standard for confirming amyloid pathology. Consequently, clinicians have turned to alternative diagnostics that can be deployed in primary‑care settings. Blood‑based biomarkers, such as those in C2N’s Precivity® suite, promise to fill this gap by delivering reliable amyloid information through a simple draw, reducing costs and turnaround times.

The scientific credibility of PrecivityAD2 rests on multiple peer‑reviewed studies. A JAMA‑published trial of 1,200 patients demonstrated that plasma p‑tau217 and Aβ42/Aβ40 ratios accurately identified amyloid pathology, outperforming standard clinical assessments. Independent validation in npj Dementia confirmed high sensitivity and specificity against PET imaging. Regulatory momentum further bolsters confidence: the test holds FDA Breakthrough Device designation and UK MHRA registration, signaling both safety and commercial viability. For clinicians, the assay offers a quantifiable, CLIA‑certified metric that can guide therapeutic decisions, especially as disease‑modifying drugs receive approval in the region.

The C2N‑SouthGenetics partnership translates this scientific promise into market reality. SouthGenetics brings two decades of regional distribution expertise, enabling country‑specific activation, physician education and reliable sample logistics. By embedding Precivity® into existing laboratory networks, the alliance can rapidly scale access, positioning both companies as key suppliers in the emerging Alzheimer’s diagnostics market. For pharmaceutical firms developing anti‑amyloid therapies, broader biomarker availability simplifies patient identification for clinical trials and post‑approval treatment pathways, ultimately accelerating the adoption of next‑generation Alzheimer’s care across Latin America.