Opening The Door To Precision Treatment
Innovations in Alzheimer’s diagnosis continued to gain momentum in 2025, catalyzed by the ADDF. In a major milestone for the field, the FDA approved the first Alzheimer’s blood tests, including one from Fujirebio—supported by the ADDF since 2021—and another developed by Roche and Eli Lilly. C2N Diagnostics, with which the ADDF has maintained a nearly 20-year partnership, also submitted its PrecivityAD2 blood test for FDA review. All of this progress marks a key step toward broadening the availability of blood-based diagnostics, which will enable earlier diagnosis and intervention, moving the field toward a new era of precision medicine.
The Transformational Power of AI
In August, our team had the privilege of meeting with Bill Gates in Seattle to share the extraordinary progress of the DxA and our bold vision for the future. One major milestone: the ADDF’s SpeechDx program released its inaugural speech dataset. Speech is a goldmine of insight; it’s measurable with everyday devices, scalable across populations, and a promising early indicator of cognitive decline. With this new dataset, our partners at Siemens Healthineers and Callyope can now build powerful AI-driven tools to forecast Alzheimer’s development, track progression, and guide interventions before symptoms ever appear.
The Future Starts Now
Our Diagnostics Accelerator is advancing digital biomarkers, AI-powered tools, and multi-pathway blood panels that will enable even earlier, more personalized intervention – ultimately opening the door to precision treatments and prevention for every patient. Several of these promising programs are outlined below.
Enabling Next-Generation In Vitro Diagnostics
Alamar Biosciences is working to translate its ARGO-HT research platform into an FDA-cleared system to support the development of in vitro diagnostic tests – the gold standard of diagnostics. The ARGO-HT System automates ultrasensitive, high-throughput NULISA assays, enabling precise detection of blood-based biomarkers for Alzheimer’s and other dementias. The ADDF invested a landmark $10 million to help advance this technology toward a first of its kind blood panel in Alzheimer’s.
Advancing Global Quality Control in Alzheimer’s Biomarker Testing
The University of Gothenburg Quality Control Program, led by Goodes Prize recipient Henrik Zetterberg, aims to ensure consistent, high-quality, and reproducible blood and CSF testing is conducted across labs worldwide, allowing for more standardized and reliable tests for patients. As testing and treatment become more widespread, quality control and proficiency testing programs will become a regulatory necessity. With the ADDF’s support, the program will be expanded beyond the current 120 labs, ensuring quality control will be available beyond existing testing platforms.
Integrating Multi-Omics and AI for Early Alzheimer’s Detection
Superfluid Dx is developing a novel blood-based diagnostic approach that combines cell-free RNA and proteomic data with advanced AI to capture a more complete picture of the underlying pathobiology of Alzheimer’s disease. This multimodal strategy, supported by the ADDF, aims to enable earlier detection, more accurate prognosis, and a new framework for AI-driven precision medicine in Alzheimer’s and other neurodegenerative diseases.