Fujirebio Submits FDA Regulatory Filing for Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test as an Aid to Identify Patients with Amyloid Pathology Associated with Alzheimer’s Disease

MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse^® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD).

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD. β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD.

AD is a devastating condition that afflicts more than 6 million Americans and is a leading cause of disability and death. Access to reliable diagnostic tools is currently limited. Diagnosis involves a variety of subjective measures and costly or invasive procedures, such as amyloid positron emission tomography (PET) scans and cerebral spinal fluid (CSF) tests. As a result, many patients are not diagnosed until their disease has advanced, limiting the benefits of available treatment options.

The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022.

“The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective. An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally. As part of our worldwide commitment to improving the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.

Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at www.fujirebio.com/alzheimer.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio.com.