Malvern-based Fujirebio Diagnostics has received marketing authorization from the FDA for its diagnostic test for Alzheimer’s disease, writes John George for the Philadelphia Business Journal. 

Alzheimer’s is a progressive brain disorder that afflicts more than five million Americans, and this number will most likely triple by 2050. Existing diagnostic methods are limited because the disease takes many years to develop before any symptoms are apparent. 

The company touts the biomarker test Lumipulse as the first in vitro diagnostic test that is available in the U.S. to help in the evaluation of patients for Alzheimer’s disease. It is meant for use in patients age 55 and older who have cognitive impairment and are being evaluated for Alzheimer’s disease and other possible causes. 

According to Monte Wiltse, Fujirebio’s CEO, the pending launch of Lumipulse represents an “important milestone” in the work to turn Alzheimer’s disease into a manageable disease. 

“Patients, physicians, and families (will) now have a valuable new tool to help identify those individuals whose early symptoms may be indicative of AD, providing the opportunity to adopt lifestyle changes and potentially to access new therapies aimed at slowing or stopping disease progression,” said Witse. 

Read more about Fujirebio Diagnostics in the Philadelphia Business Journal.