The new plasma-based diagnostic tool is intended to improve early detection of Alzheimer’s through a less invasive method.
The U.S. Food and Drug Administration (FDA) has cleared the first blood test authorized to support the diagnosis of Alzheimer’s disease in adults aged 55 and older showing symptoms. Developed by Fujirebio Diagnostics, Inc., the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test measures protein levels in blood plasma that correlate with amyloid plaque buildup in the brain—a key indicator of Alzheimer’s.
This advancement offers a less invasive, more accessible alternative to PET scans or spinal taps, which are traditionally used for diagnosis. Clinical trials showed the test was accurate in over 90 percent of positive and 97 percent of negative cases when compared to those standard methods.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Dr. Marty Makary. “Knowing that 10 percent of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
As the Lord Leads, Pray with Us…
- For Commissioner Makary to receive God’s wisdom as he oversees the Food and Drug Administration.
- For Secretary Kennedy to be prudent in his leadership of the Department of Health and Human Services and its many agencies.
Sources: Food and Drug Administration
