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

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.”