Fujirebio Diagnostics’ Malvern site played key role in new Alzheimer’s blood test
The Chester County company's product is the first blood test cleared by the FDA to help diagnose Alzheimer's.
The Malvern location of Fujirebio Diagnostics Inc.’s played a key role in the clinical development of the first FDA-approved blood test that can help diagnose Alzheimer’s disease.
The test, cleared May 16 for people 55 and older, is expected to help identify patients who might benefit from new drugs that have been shown to slow the type of the dementia that afflicts 6 million Americans.
Fujirebio Diagnostics has had a presence in Malvern since 1998, when the Japanese company acquired the diagnostics division of Centocor, one of the Philadelphia region’s early successes in biotechnology. Johnson & Johnson bought Centocor the following year.
The new test is designed to identify a form of brain plaque that is seen as an indicator of Alzheimer’s. Previously, the FDA had approved tests of spinal fluid or brain scans to check for the plaque, known as beta-amyloid. The blood test is less expensive and less invasive.
Fujirebio Diagnostics employees in Malvern assessed the performance of the blood tests’ two active components and figured out what ratio of the two components to use in the test, Diana L. Dickson, vice president for clinical and regulatory sciences, said in an email. Staff in Malvern also determined what values the test had to show to be considered positive, and prepared the FDA application, she said.
Components for the test and the instrument system are manufactured in Belgium or Japan, Dickson said.
Fujirebio Diagnostics employs 351 people in Malvern.
This article contains information from The Associated Press.