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New biomarker blood tests gain traction in Alzheimer's diagnosis

October 16, 2023

Labcorp has begun offering physicians a blood test it says measures markers for amyloid, tau, and neurodegeneration, with a list price of $626. The new ATN Profile combines three blood biomarkers to identify and assess biological changes associated with Alzheimer's disease that can help accelerate the path to diagnosis and intervention. (Labcorp, 2023)

Labcorp is not the first company to develop alternatives to the more invasive CSF tests with lumbar puncture and expensive PET brain scans currently being used to identify the biological changes associated with Alzheimer's disease. This year alone, Quest Diagnostics, C2N Diagnostics, and Quanterix have all launched new blood tests—including one for consumers—but none have been established as accurate, formally approved by regulators, or reimbursed by insurers. (Reuters, 2023; Park, 2023)

Researchers say there's still debate over which biomarkers, or proteins in the blood, signal the presence of amyloid and tau in the brain and more research is needed to understand the impact of race, underlying medical conditions, and other factors. Thus, medical experts and company executives expect that it will be another couple of years before such tests become widespread and commonplace. (Reuters, 2023)

Nonetheless, the need for blood tests has become more pressing since the FDA approved Leqembi in July. The agency is currently reviewing a similar drug, donanemab, from Eli Lilly.(Reuters, 2023)

Until recently, it's been difficult to specifically identify the biological changes consistent with Alzheimer's disease through widely available methods. The standard approach, which includes a physical exam, routine blood and urine tests, and cognitive testing may not provide distinct answers and may result in delayed referral to a specialist. The ATN Profile gives physicians an easily accessible and interpretable blood test to assess pathologies associated with Alzheimer's disease and other neurodegenerative conditions, potentially speeding up the time it takes to order further testing, reach a diagnosis, and begin treatment for the disease. (Labcorp, 2023; Park, 2023)

The Alzheimer's Association estimates that 6.7 million Americans have the disease, but also notes that the number could be 30% lower if biological testing is used. (Reuters, 2023)

Sources:

(2023, October 11). Labcorp. Labcorp Launches New Test to Accelerate Path to Diagnosis of Alzheimer's Disease. https://www.labcorp.com/labcorp-launches-new-test-accelerate-path-diagnosis-alzheimers-disease

Beasley, D. (2023, October 11). Reuters. Blood tests needed for widespread Alzheimer's diagnosis on the way. https://www.reuters.com/business/healthcare-pharmaceuticals/blood-tests-needed-widespread-alzheimers-diagnosis-way-2023-10-11/

Park, A. (2023, October 11). FIERCEBiotech. Labcorp launches tri-biomarker blood test to aid Alzheimer's diagnosis. https://www.fiercebiotech.com/medtech/labcorp-launches-tri-biomarker-blood-test-aid-alzheimers-diagnosis