Fujirebio’s Diagnostic Test for Beta-amyloid Plaques Given FDA OK
The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease.
The Lumipulse G β [beta]-Amyloid Ratio (1-42/1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults ages 55 and up who are being evaluated for Alzheimer’s and other causes of cognitive decline.
“FDA authorization of the Lumipulse G β-Amyloid Ratio (1-42/1-40) test and the upcoming U.S. launch are important milestones in the campaign to transform [Alzheimer’s] into a manageable disease,” Monte Wiltse, president and CEO at Fujirebio, said in a press release.
Fujirebio applied for FDA authorization late last year.
“Patients, physicians and families now have a valuable new tool to help identify those individuals whose early symptoms may be indicative of [Alzheimer’s], providing the opportunity to adopt life style changes and potentially to access new therapies aimed at slowing or stopping disease progression,” Wiltse said, adding that the authorization reflects the company’s “ongoing commitment to working with the healthcare community and [Alzheimer’s] advocates to achieve significant progress against this devastating disease.”
Alzheimer’s is marked by the presence of plaques, or tangles, of beta-amyloid protein in the brain, which is thought to drive the disease. Testing for beta-amyloid plaques is commonly a part of the diagnostic evaluation for Alzheimer’s, but until now, the only way to check for these plaques was a PET scan.
The Lumipulse test is designed to measure levels of beta-amyloid protein in a patient’s cerebrospinal fluid (CSF), the liquid around the brain and spinal cord. The test measures two forms of the protein, referred to as beta-amyloid 42 and beta-amyloid 40.
By calculating the ratio between these two forms of beta-amyloid, the test can determine whether a person is likely to have amyloid plaques. According to the FDA, a positive result on the Lumipulse test is “consistent with the presence of amyloid plaques, similar to what would be seen in a PET scan,” while a negative test result is consistent with no amyloid plaques on a PET scan.
“The availability of an in vitro, or lab, 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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a separate release.
“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,” Shuren said.
The Lumipulse test is not intended to be used as a stand-alone measure for diagnosing Alzheimer’s, but may aid in the diagnostic work-up. Diagnosing Alzheimer’s has historically relied mainly on cognitive assessments, but these are not accurate for detecting Alzheimer’s in its early stages most of the time, according to Fujirebio.
“The development of accurate tests for Alzheimer’s using biomarkers found in the CSF or other bodily fluids is a requirement if we are to make real progress against this dreaded disease,” William Hu, MD, PhD, chief of the division of cognitive neurology at Robert Wood Johnson Medical School, said. Research in Hu’s lab has focused on Alzheimer’s biomarkers.
“The importance of early diagnosis in Alzheimer’s is widely acknowledged, but until now, there has been no approved biomarker test available to clinicians and patients,” Hu said. “FDA authorization of the Fujirebio β-Amyloid Ratio test is a significant advance that marks the advent of a new era, facilitating more efficient clinical trials for new Alzheimer’s therapies and enabling patients and their doctors to make more informed decisions and take action much earlier in the disease process.”
May 16, 2022