New diagnostic test for early Alzheimer’s cleared by US FDA

(Eagle News) — The U.S. Food and Drug Administration clears marketing for the first in vitro diagnostic test for early detection of Alzheimer’s Disease.

The FDA said the test is to be used in adult patients aged 55 years and older who present with cognitive impairment and are being evaluated for Alzheimer’s Diseae and other causes of cognitive decline.


Dr. Jeff Shuren of the FDA explained how this new test benefits patients and their families.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” said Shuren. “With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.”

(Eagle News Service)