FDA Clears Blood-Based Biomarker Test for Alzheimer's Disease in Primary Care

The U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau181 plasma test, developed by Roche, as the first blood-based biomarker test for Alzheimer's disease for use in primary care to rule out amyloid pathology. This new diagnostic tool can significantly improve the diagnostic process by preventing unnecessary specialized testing for individuals whose cognitive issues stem from non-Alzheimer's causes. The Alzheimer's Association is committed to ensuring blood tests are used appropriately and effectively across all care settings, and urges providers to utilize guidance on blood biomarker testing in conjunction with clinical judgement.

Key Takeaways:

• The FDA has cleared the Elecsys pTau181 plasma test, developed by Roche, as a blood-based biomarker test for Alzheimer's disease in primary care to rule out amyloid pathology.
• The test can help primary care physicians determine which patients do not require Alzheimer's-related follow-up tests, such as PET scans or cerebrospinal fluid analysis.
• The Alzheimer's Association has published clinical practice guidelines for the use of blood biomarker tests in specialty care settings, which are continually updated to reflect the evolving scientific landscape.
• The Association urges providers across clinical care settings to utilize guidance on blood biomarker testing in conjunction with clinical judgement to support effective and appropriate use of these tools.
• The test is intended for use in adult patients, aged 55 years and older, presenting with signs or symptoms of cognitive impairment.
• The test can help prevent unnecessary specialized testing for individuals whose cognitive issues stem from non-Alzheimer's causes.
• Alzheimer's disease diagnosis remains a multi-step process.
• The Alzheimer's Association is committed to ensuring blood tests are used appropriately and effectively across all care settings.

Statistics:

• The Elecsys pTau181 blood test is intended for use in adult patients, aged 55 years and older, presenting with signs or symptoms of cognitive impairment.
• The FDA has cleared the first blood-based biomarker test for Alzheimer's disease for use in primary care.
• The Alzheimer's Association has published clinical practice guidelines for the use of blood biomarker tests in specialty care settings.
• The test can help prevent unnecessary specialized testing for individuals whose cognitive issues stem from non-Alzheimer's causes.
• Alzheimer's disease affects over 6 million people in the United States.

Sources:

• Alzheimer's Association (Oct. 13 --- date not specified in the source material). This press release is a direct quote from the source material.
• U.S. Food and Drug Administration (FDA) ( cleared the Elecsys pTau181 plasma test developed by Roche as a blood-based biomarker test for Alzheimer's disease in primary care.
• National Institutes of Health (NIH) (historic investment in Alzheimer's and dementia research).