New blood test offers early detection of neurodegenerative disorder Image By HPN Staff The Food and Drug Administration (FDA) recently approved a new tool in the fight against Alzheimer’s disease — a blood test that detects plaques known to be linked to the disease. The test, developed by the Japanese firm Fujirebio Diagnostics, is called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, and works by detecting and measuring amyloid and tau, two forms of amyloid-beta proteins in the blood, which form plaques in the brains of Alzheimer’s patients. Why it matters Alzheimer’s is a degenerative brain disease that affects an estimated 7.2 million Americans aged 65 and older — or one in nine Americans within that age group — and is responsible for 60-80% of dementia cases. While there is currently no cure for the disease, experts emphasize that early detection remains crucial to allow time for reducing exposure to risk factors and planning for future lifestyle changes and disease management. Furthermore, the two medications that are approved for the treatment of Alzheimer’s, Leqembi and Kisunla, are designed to slow the progression of the disease in its early stages. Prior to the FDA’s approval of the blood test, the only methods available for detecting amyloid plaque buildup were a PET scan — which is expensive and unavailable in many areas — or a spinal tap. The ability to detect and measure these plaques via blood drawing is expected to make testing less costly and more widely available to people in rural and underserved areas. It could also encourage more people to take the test before Alzheimer’s symptoms take hold. The bigger picture As part of their announcement, the FDA warned that side effects could include both false positives and false negatives. False positives could result in unnecessary anxiety and psychological distress, as well as potential issues acquiring life insurance. False negatives could result in unneeded additional diagnostic testing and delays in treatment. The blood test is not for general screening and is approved only for those 55 years of age and older who exhibit symptoms of cognitive decline. Still, studies have demonstrated the high accuracy of the Lumipulse test in the target population, which, combined with the lower cost and greater availability compared to existing test modalities, offers expanded opportunities for early screening of Alzheimer’s. The FDA approval also clears the way for insurance reimbursement, potentially including Medicaid and Medicare.
