We applaud the FDA’s clearance for Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test another important milestone that has the potential to advance the Alzheimer’s diagnostic process and bring more accessible, scalable tools to physicians and specialists, ultimately benefitting people living with Alzheimer’s disease. Developed as a collaboration between Eli Lilly & Co and Roche, Elecsys® pTau217 is the “…first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.”
GAP was proud to have contributed to this effort by participating in the necessary clinical trial to get this market ready, through our Trial Execution Services Teams, providing high-touch support and resources. Moments like this demonstrate how support from our teams can lead to major milestones in the field moving it forward.
The rapid advancement of blood-based biomarker tests represents a landmark step forward in the detection and diagnosis of Alzheimer’s disease. As access to these innovative technologies expands, it is essential that they reach people from communities historically underserved and understudied in research. Ensuring that future advances in Alzheimer’s diagnostics are accessible, inclusive and equitable will be critical for the benefits of scientific progress to reach everyone.
We thank the FDA for this clearance ,which is helping accelerate progress in science, creating yet another pathway towards a faster Alzheimer’s diagnosis. We hope that the path forward continues with rigor so that we continue the momentum to improve the lives of all impacted by this terrible disease.