MOMENTUM IN ALZHEIMER’S BIOMARKERS PROPELS FIELD TOWARDS NEXT GENERATION OF CARE

ADDF-funded C2N Diagnostics announced an agreement with Mayo Clinic Laboratories to offer their blood tests, boosting access globally.

Workgroup convened by the Alzheimer’s Association released revised diagnostic criteria that move the field towards biology-based diagnoses.

NEW YORK—June 28, 2024—Progress in the development of biomarkers and diagnostics continues to define the new era of Alzheimer’s research, as shown by the Alzheimer's Association’s revised diagnostic criteria that recommend centering diagnoses and staging around the disease biology. This news comes on the heels of ADDF-funded C2N Diagnostics announcing a new agreement with Mayo Clinic Laboratories to make the company’s blood tests more widely available. Leveraging a biology of aging approach to develop new drugs and diagnostics will be integral to the next generation of care, and with accessible blood-based biomarkers now at the forefront, the field is closer than ever to precision Alzheimer’s care.

“These advancements move us closer to the holy grail of Alzheimer’s care—combination therapy and precision medicine. We must gain a better understanding of the relationship between the disease biology and its progression, which requires the use of accessible and scalable biomarkers alongside the monitoring of clinical symptoms,” says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the ADDF. “Increasing availability of C2N’s first-in-class and high performing blood test expands our arsenal of diagnostic tools, helping accelerate research while enabling early detection.” 

With the advent of new disease-modifying therapies, there is a pressing need to treat Alzheimer’s based on the underlying disease biology, like in cancer. The revised criteria depart from the traditional, clinical symptom-based diagnoses to a broader biological framework that examines the disease biology in conjunction with clinical symptoms to define and stage Alzheimer's. Like diagnostic models employed in conditions such as heart disease, the six clinical stages in the recommendations range from asymptomatic with amyloid in the brain (Stage 1) to severe dementia (Stage 6). These recommendations also reflect recent progress in the development of blood-based biomarkers, several of which have been found to be as accurate as PET scans, the current gold standard of Alzheimer’s diagnostics. 

“The use of new diagnostic tools to confirm disease pathology is crucial, however, when patients are asymptomatic and have the pathology, diagnosing Alzheimer’s needs to be approached with caution,” notes Dr. Fillit. “While it is important to continue building our understanding of pre-clinical Alzheimer’s, the field is not ready to begin diagnosing asymptomatic patients solely on the presence of plaques. Research shows that having amyloid in the brain does not guarantee the development of Alzheimer’s.”

Disease staging and diagnosis is only possible with the correct biomarkers. C2N—which received seed funding from the ADDF—developed the first blood test to market, which has proven to be highly sensitive and accurate. C2N is part of the ADDF’s robust and diverse biomarker portfolio, led by the Diagnostics Accelerator (DxA). Founded in 2018 by Leonard A. Lauder, Bill Gates, and other leading philanthropists, the DxA is a $100 million global initiative aimed at fast-tracking the development of accessible, affordable, and scalable diagnostic tools for Alzheimer’s. To date, the DxA has invested nearly $70 million in over 60 projects.

“These developments signify a shift where blood tests will soon become the gold standard, but it is important to remember that blood-based biomarkers cannot work alone,” said Dr. Fillit. “To stop Alzheimer’s in its tracks, we will need to deploy blood tests alongside digital and ocular screening tools to help predict Alzheimer’s risk and offer personalized treatment plans that can optimize care or even prevent the disease.”