New diagnostic test for Alzheimer’s gets FDA approval - SpecialtyRx
May 25, 2022
New diagnostic test for Alzheimer’s gets FDA approval

First in vitro diagnostic test ready to go to market,

The Lumipulse G β-Amyloid Ratio is the first in vitro diagnostic test to detect brain plaques tied to Alzheimer’s disease. The test analyzes spinal fluid, evaluating proteins that can form brain amyloid beta plaques, a sign of Alzheimer’s. The test is for adults over 55, who are exhibiting signs of cognitive decline.

The test offers a faster, more convenient alternative to expensive positron emission tomography (PET) brain scans, providing the same data without radiation risk. While this new test is exciting, the FDA has cautioned physicians not to rely solely on Lumipulse because positive results could indicate other types of neurologic conditions and signs of brain plaques may also be detected in cognitively healthy older people. However, utilizing Lumipulse in conjunction with other clinical evaluations can reduce the need for costly, time-consuming PET scans.

“At SpecialtyRx we are always excited to hear about the latest innovations in our industry, whether it be new testing, medications or treatments. Staying on the cutting edge helps to ensure we are serving our clients in the best ways possible,” stated Joe Kubulak, Chief Operating Officer at SpecialtyRx.