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Fujirebio Diagnostics Files 510(k) With FDA for Lumipulse® G β-Amyloid Ratio (1-42/1-40) In Vitro Diagnostic Test

·3-min read

—When Cleared, FDA-Designated Breakthrough Device Expected to Be a Commercially Available In Vitro Diagnostic for Patients Being Evaluated for Alzheimer’s Disease in the U.S.—

Fujirebio Diagnostics, Inc., a consolidated subsidiary of H.U. Group Holdings, Inc., today announced that it has filed its Lumipulse® G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test with the U.S. Food and Drug Administration (FDA) for 510(k) premarket clearance. The test was granted Breakthrough Device Designation by the FDA in February 2019 and is expected to be among the first commercially available in vitro diagnostic tests in the U.S. to help in the assessment of Alzheimer’s disease. The test is analyzed using Fujirebio’s fully automated Lumipulse G1200 instrument system.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201202005029/en/

Fujirebio’s fully automated LUMIPULSE® G1200 system will analyze its expected in vitro diagnostic test for Alzheimer's disease. (Photo: Business Wire)

Alzheimer’s disease is a devastating condition, characterized by amyloid plaques in the brain, which afflicts more than 5 million Americans and is a leading cause of disability and death. Current tools available to evaluate amyloid pathology such as amyloid PET imaging can be expensive, time consuming, and difficult to access. As a result, many patients are not diagnosed until their disease is well advanced, with few available treatment options.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 found in human cerebral spinal fluid (CSF) into a numerical ratio of β-Amyloid1-42/β-Amyloid1-40. The ratio is a semiquantitative in vitro diagnostic test intended to be used in adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

"The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer’s disease contributes to its late diagnosis and inadequate treatment," says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. "We designed our Lumipulse G β-Amyloid Ratio test to help physicians triage their patient much sooner when effective interventions are more feasible using these well-researched β-amyloid biomarkers. Accurate and earlier intervention will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of Alzheimer’s disease increases with a rapidly aging population globally."

The Lumipulse G β-Amyloid and Tau tests are already CE-marked for use in the European Union.

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of H.U. Group Holdings, Inc. and 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. H.U. Group Holdings, Inc. (formerly known as Miraca Holdings Inc.) is a listed company on the Tokyo Stock Exchange – TYO: 4544.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201202005029/en/

Contacts

Hiroshi Sekiya
Fujirebio US, Inc.
Office: 484-395-5557
hiroshi.sekiya@fujirebio-us.com

Debra Harrsch
Brandwidth Solutions LLC
215-997-8575
dharrsch@brandwidthsolutions.com