ADDF's New Investment to Enhance Quality Control in Alzheimer's Biomarkers Testing

Investment to Enhance Biomarker Testing

The Alzheimer's Drug Discovery Foundation (ADDF) has declared a significant commitment of up to $2 million to broaden a quality control initiative designed for blood and cerebrospinal fluid (CSF) biomarkers. This effort, known as the University of Gothenburg Quality Control Program, is managed by the Diagnostics Accelerator (DxA) and the Global Biomarker Standardization Consortium (GBSC). Spearheading this initiative are prominent Alzheimer's researchers, Henrik Zetterberg and Kaj Blennow at the University of Gothenburg.

This innovative program aims to secure high-quality, consistent, and reproducible testing protocols across laboratories internationally. The intention is to make head-to-head comparisons of various tests viable and to provide more standardized and reliable tests for patients seeking Alzheimer's diagnoses.

According to Dr. Howard Fillit, Co-Founder and Chief Science Officer at the ADDF, the Alzheimer's landscape is rapidly changing, with breakthroughs in biomarker technology leading to novel diagnostic tests. While existing regulatory measures do impose some level of control, the diverse range and volume of testing being performed highlight an urgent need for reinforced quality control in a growing number of laboratories. The core mission of the DxA is to expedite the development of testing tools that are accessible, reliable, and robust. This expansion of quality control is crucial for ensuring that patients everywhere receive accurate diagnoses irrespective of the testing environment.

Initially launched in 2009, the Alzheimer's quality control program aims to oversee the efficiency of CSF biomarker assessments across both clinical and significant research laboratories while preventing issues like longitudinal drift and variations between batches. The program has progressively included blood biomarkers across several platforms. With the support from DxA, the initiative will be extended to over 120 labs, broadening its reach beyond the current six testing platforms. Given the expanding demand for testing and treatments, the introduction of quality control and proficiency testing standards is poised to become a regulatory requirement to maintain high testing standards across varied laboratory environments.

Dr. Henrik Zetterberg emphasized the importance of clinical laboratories participating in quality control initiatives to ensure accurate diagnostic outcomes. He mentioned that the overarching aim of this program is to enhance the quality of both CSF and blood biomarker assessments resulting in consistent and dependable results across different labs and facilitating accurate diagnoses for patients.

Furthermore, external quality control assessments validate a lab's accuracy by contrasting its results against an external benchmark or peer assessments. Such initiatives not only unveil systematic errors but also help in tracking performance trends, complying with regulations, and advancing a lab's methodologies.

Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures, highlighted the significance of improving access to high-quality, reliable diagnostics. As new and innovative diagnostic solutions, primarily blood tests for Alzheimer's detection, continue to emerge, he expressed enthusiasm about investing in the enhancement of the quality control program at the University of Gothenburg. By doing so, the initiative will enable a broader testing of biomarkers than currently available, thus improving both consistency and reliability of diagnoses and, consequently, treatment options for patients worldwide.

About ADDF

Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is committed to hastening the development of drugs that prevent, treat, and potentially cure Alzheimer's disease. Focused solely on funding Alzheimer's-related drug development, the foundation employs a venture philanthropy approach to support research in academia and the biotech realm. ADDF's accomplishments have significantly contributed to the introduction of the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®), greatly affecting the current robust drug pipeline. The foundation has allocated over $370 million towards supporting 765 drug discovery programs, biomarker research, and clinical trials across 21 nations. For more information, visit www.alzdiscovery.org.

About the Diagnostics Accelerator (DxA)

Founded in July 2018, the Diagnostics Accelerator is a $100 million global research initiative launched with support from key figures including ADDF Co-Founder Leonard A. Lauder, Bill Gates, and Jeff Bezos. The aim is to expedite the development of innovative biomarkers for early diagnosis of Alzheimer's disease and related dementias, promoting the clinical advancement of targeted treatments. The program offers translational research grants and expert consulting, helping researchers in both academia and industry develop novel diagnostic biomarkers effectively.