The US Food and Drug Administration (FDA) has approved Japan-based Fujirebio to market its blood test for diagnosing Alzheimer’s disease in some patients. The test, called Lumipulse, measures two proteins in the blood associated with amyloid plaques, which are linked to the disease.
The FDA cleared the test for use in adults aged 55 and older who present at specialized care settings with signs of cognitive decline. The agency says the test is effective, with 91.7% of patients testing positive also showing up in brain scans or spinal fluid tests. Experts had previously been wary of blood tests for Alzheimer’s due to concerns over accuracy and regulatory oversight.
However, a federal judge recently ruled against the FDA’s regulation on laboratory-developed tests, which are used by many clinical laboratories to diagnose Alzheimer’s and other conditions. The ruling removes burdensome regulations that were intended to protect patients from inaccurate results.
Fujirebio’s Lumipulse test is now available in US clinical laboratories using the company’s equipment, which can run 120 tests an hour. Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated that the clearance “makes it easier and potentially more accessible for U.S. patients earlier in the disease.”
Source: https://www.cbsnews.com/news/fda-first-alzheimers-blood-test-fujirebio