May 16 (UPI) — The U.S. Food and Drug Administration on Friday approved a new blood test for the early detection of Alzheimer’s disease in patients beginning to show cognitive decline.
Fujirebio Diagnostics, a firm dedicated to developing medical diagnostic products, has been cleared by the FDA to begin marketing the test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio.
“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” said Dr. Michelle Tarver, the director of the Center for Devices and Radiological Health.
“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
The test works by looking at the ratio of two proteins in a patient’s blood plasma, which together are a sign of amyloid plaque buildup in the brain, which is a hallmark of Alzheimer’s disease.
Until now, confirming amyloid plaque has required costly PET brain scans or an invasive spinal tap to test cerebrospinal fluid. The new blood test would be cheaper and safer for patients testing for Alzheimer’s disease.
To clear the new blood test, the FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from adults who were cognitively impaired and compared the results to those from tests using PET scans or spinal taps.
In the study, when the blood test indicated a person likely had Alzheimer’s-related plaques, it was correct about 92% of the time, the FDA determined.
When the test said a person likely didn’t have plaques, it was correct about 97% of the time.
“These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired,” the FDA said in a news release.
“The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.”
