9 May 2022 - - The US Food and Drug Administration has granted De Novo marketing authorization for US-based Fujirebio Diagnostics, Inc's Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for the assessment of β-Amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline, the company said.

The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA-authorized in vitro diagnostic test in the US to aid in the assessment of Alzheimer's disease and other causes of cognitive decline.

Alzheimer's disease afflicts more than five m Americans, a number that is expected to triple to almost 14m by 2050.

It is a leading cause of disability and death, but current diagnostic methods are limited.

AD develops over many years, long before symptoms are evident, but the lack of accessible diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain.

A key feature of AD is the presence of β-Amyloid plaques in the brain. β-Amyloid plaques are believed to contribute to the loss of cognitive function that characterizes AD, but accurately evaluating amyloid pathology has been difficult.

Clinicians have relied primarily on cognitive assessments, including standardized cognitive screening tests.

However, in early stages of the disease, a diagnosis of Alzheimer's disease relying primarily on cognitive tests has been shown to be incorrect in approximately 50-60% of patients.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) offers an alternative to the current standard for determining amyloid-pathology, amyloid positron emission tomography brain imaging which is expensive, subjective, time consuming, inaccessible to many Americans, and often not covered by health insurance.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is an accurate, minimally invasive, accessible measure of β-Amyloid that can detect the formation of amyloid plaques early in the disease.

It is intended for use in adult patients aged 55 years and older presenting with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

The β-Amyloid Ratio test measures the concentrations of β-Amyloid 1-42 and β-Amyloid 1-40 in the CSF to calculate a numerical ratio as a proxy for the presence of β-Amyloid plaque in the brain.

William Hu, MD, PhD is Chief, Division of Cognitive Neurology at Robert Wood Johnson Medical School and Principal Investigator of the Hu Lab, which focuses on researching fluid biomarkers for AD and other neurodegenerative disorders.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is not intended as a screening or standalone assay to diagnose AD.

Results must be interpreted in conjunction with other patient clinical information. The assay is analyzed on Fujirebio's fully automated Lumipulse G1200 instrument system, which is available to clinical laboratories nationwide.

Fujirebio Diagnostics, a wholly owned subsidiary of Japan's H.U. Group Holdings, Inc. and Fujirebio Holdings, Inc., is a 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.

H.U. Group Holdings, Inc. (formerly known as Miraca Holdings Inc.) is a listed company on the Tokyo Stock Exchange (TYO: 4544).