The Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator (DxA) Invests in Expansion of Quality Control Program for Blood and CSF Biomarkers

New investment helps to ensure patients can access high-quality and reproducible testing across labs worldwide

NEW YORK, June 2, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) today announced an investment of up to $2M to expand a quality control program for blood and CSF biomarkers, titled the University of Gothenburg Quality Control Program supported by the Diagnostics Accelerator (DxA) and Global Biomarker Standardization Consortium (GBSC). The program, led by global Alzheimer's experts Henrik Zetterberg and Kaj Blennow from the University of Gothenburg, will ensure consistent, high-quality, and reproducible testing is conducted across labs worldwide, allowing for head-to-head comparisons between tests as well as more standardized and reliable tests for patients.

"The Alzheimer's field is evolving rapidly with advances in biomarkers bringing new and novel tests to market as part of our efforts to provide patients with an early and accurate diagnosis," said Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF.  "While regulatory clearance and testing provides some control, the volume and diversity of testing being conducted creates a pressing need for the expansion of quality control efforts in more labs. A core tenet of the Diagnostics Accelerator (DxA) is to accelerate the development of accessible, reliable, and capable diagnostic tools. This program is an important step forward in ensuring that patients worldwide receive an accurate and consistent diagnosis regardless of the test setting."

The Alzheimer's quality control program launched in 2009 with the goal of establishing a tool to monitor the performance of cerebrospinal fluid (CSF) biomarker measurements across clinical laboratories and large research laboratories, while also protecting against longitudinal drift and batch-to-batch variations. The program has grown to include blood biomarkers across multiple platforms. The DxA's investment will enable the expansion of the program beyond the current 120 labs, ensuring quality control will be available beyond the existing six testing platforms. As testing and treatment becomes more widespread, quality control and proficiency testing programs will become a regulatory necessity to guarantee high-quality testing across various lab settings.

"Clinical laboratory participation in quality control programs is essential to assure accurate results," commented Henrik Zetterberg, MD, PhD, Professor of Neurochemistry and Head of the Department of Psychiatry and Neurochemistry at the University of Gothenburg and Clinical Chemist at Sahlgrenska University Hospital and 2024 Goodes Prize winner. "The long-term goal of this program is to improve the quality of procedures in CSF and blood biomarker measurements, producing stable and precise results across labs, ultimately leading to more accurate patient diagnostics. We are grateful for the Diagnostics Accelerator's continued support and leadership in the field."

External quality control testing confirms laboratory accuracy and reliability by comparing test results to an external standard or peer group. These programs have helped identify systematic errors, assess performance trends, maintain regulatory compliance, and improve individual laboratory methodology.

"Increasing early access to high-quality, reliable diagnostics is essential to helping the millions of people annually who develop Alzheimer's disease," said Niranjan Bose, Managing Director, Health and Life Sciences at Gates Ventures. "As we continue to see new and promising advancements in diagnostics, especially with blood tests for Alzheimer's diagnosis coming to market, we are excited to invest in expanding the Quality Control (QC) program at the University of Gothenburg to more labs. This will enable the testing of biomarkers beyond what is offered today, improving consistency and reliability, and ultimately ensuring that patients worldwide receive more accurate diagnoses and access to better treatment options."

About The Alzheimer's Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: http://www.alzdiscovery.org/.

ABOUT THE DIAGNOSTICS ACCELERATOR (DxA)
The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias.

This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.

SOURCE Alzheimer's Drug Discovery Foundation