October 17, 2025, Copenhagen – We are excited to announce the successful
completion of the gMendel® Test validation study, conducted in collaboration
with Prof. Dr. Marco Casartelli, Director of the National Newborn Screening Program
(Programa Nacional de Detección Neonatal) at the Ministry of Health, Paraguay
(Ministerio de Salud Pública y Bienestar Social).
The study analysed 92 blinded samples, including both SMA-positive individuals
and healthy donors.
Key Results from the Performance Evaluation Report:
✅ Diagnostic Sensitivity: 97.6%
✅ Diagnostic Specificity: 100%
✅ Positive Likelihood Ratio: Not applicable (no false positives detected)
✅ Negative Likelihood Ratio: 0.00024
Our CTO, Zoran Velkoski, commented: “These results confirm the robustness of the
gMendel ® technology, highlighting its high sensitivity and specificity at a fraction of the
cost of existing methods. This performance paves the way for commercial adoption
and strengthens our position in the global newborn screening landscape.”
Prof. Marco Casartelli added: “gMendel ® ’s ability to deliver comprehensive, rapid, low-
cost, and automated results makes it an excellent alternative to conventional assays
and expands opportunities for early diagnosis and timely intervention.”
We are proud of this milestone and deeply motivated by its impact. The gMendel ®
technology represents a step forward in advancing genetic screening, helping
to reduce infant mortality, one of the clearest indicators of a society’s progress and
well-being.