USFDA Allows Marketing of Fujiberio Diagnostic Tests for Alzheimer’s

The US Food and Drug Administration (FDA) has approved marketing for a new diagnostic test that tests amyloid plaques in people tested for Alzheimer’s disease. According to the report, Lumipulse G 7 [beta]The amyloid ratio (1-42 / 1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults 55 years of age or older who are being assessed for Alzheimer’s and other causes of cognitive decline.

“FDA approval of the Lumipulse G7-amyloid ratio (1-42 / 1-40) test and the upcoming US launch are important milestones in the conversion campaign. [Alzheimer’s] In a manageable disease, “said Monte Wilts, president and CEO of Fujirebio, in a recent press release. Fujirebio applied for FDA approval late last year.

“Patients, physicians and families now have a valuable new tool to help identify those whose early symptoms may be indicated. [Alzheimer’s]It provides an opportunity to embrace lifestyle changes and the possibility of accessing new therapies aimed at slowing or stopping the progression of the disease, ”Wilts said.

According to doctors and experts, a plaque of beta-amyloid protein in the brain, which is thought to drive the disease, is characterized by the presence of Alzheimer’s. Tests for beta-amyloid plaques are usually part of the diagnostic evaluation for Alzheimer’s, but so far, the only way to test these plaques was with a PET scan.

The Lumipulse test is designed to measure the levels of a patient’s cerebrospinal fluid (CSF), the liquid beta-amyloid protein around the brain and spinal cord. The experiment measured two forms of the protein, known as beta-amyloid 42 and beta-amyloid 40.

“The availability of an in vitro, or lab, a diagnostic test that could 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 diagnosis,” said Jeff Shuren, MD, FDA’s Center for Divide. The director of Radiological Health said in a separate release.

According to the company, the Lumipuls test is not intended to be used as a stand-alone measure to diagnose Alzheimer’s, but may help diagnostic work-ups. Diagnosis of Alzheimer’s has historically relied heavily on cognitive assessment, but most of the time these are not accurate enough to detect Alzheimer’s at an early stage, Fujirebi claimed.

“The importance of early diagnosis [Alzheimer’s] Widely recognized, but to date, no approved biomarker tests are available for physicians and patients. FDA approval of the Fujirebio β-amyloid ratio test is a significant breakthrough that marks the dawn of a new era, providing more efficient clinical trials for newcomers. [Alzheimer’s] Therapy and enables patients and their doctors to make more informed decisions and take steps much earlier in the disease process, ”Hu said.

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