BioSynth Announces Positive Phase 3 Results for Novel Alzheimer's Biomarker Test
BioSynth has reported statistically significant results from its Phase 3 clinical trial for a blood-based biomarker test that detects Alzheimer's disease up to seven years before symptom onset.
BioSynth, a clinical diagnostics company, today announced statistically significant Phase 3 results for its BioSynth-AD blood test, a non-invasive diagnostic that detects amyloid pathology associated with Alzheimer’s disease up to seven years before clinical symptoms appear.
The randomised, double-blinded trial enrolled 3,200 participants across 18 clinical sites in eight European countries. The BioSynth-AD test demonstrated:
- Sensitivity: 91.4%
- Specificity: 88.7%
- Negative Predictive Value: 96.1%
Results were presented today at the European Congress of Psychiatry in Vienna and simultaneously published in The Lancet Neurology.
“Early detection is the key to unlocking the next generation of Alzheimer’s treatments,” said Chief Scientific Officer Dr. François Leblanc. “A blood test that any GP can order changes the entire screening paradigm.”
BioSynth plans to submit a regulatory dossier to the European Medicines Agency in Q2 2026 and to the FDA in Q3 2026.
Media Contact MediPlex Media Relations on behalf of BioSynth | media@mediplex.com
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MediPlex Media Relations
Director of Communications, MediPlex Healthcare
Media contact for MediPlex Healthcare, a medical technology and diagnostics company operating across Europe.