Fujirebio Diagnostics Receives FDA Breakthrough Device Designation for Lumipulse® G β-Amyloid Ratio (1-42/1-40) Quantitative In Vitro Diagnostic Test

Product news

Feb 14, 2019

Malvern, PA, USA -- February 14, 2019 – Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., has received Breakthrough Device Designation (formerly known as Expedited Access Pathway (EAP) designation) from the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on February 1, 2019 for the Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test. The Breakthrough Devices Program is designed to expedite the development and review of certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.

“We are very pleased that the FDA has granted us breakthrough status for this important new diagnostic tool in the fight against Alzheimer’s Disease”, said Monte Wiltse, President and CEO of Fujirebio Diagnostics, Inc. “The entire Fujirebio group of companies are committed to bringing novel diagnostic tools for Alzheimer’s Disease to healthcare systems globally, we look forward to working closely with the FDA to provide both physicians and patients this innovative, new test.”

The Lumipulse G β-Amyloid Ratio (1-42/1-40) is a quantitative in vitro diagnostic test using measurable β-Amyloid 1-42 and β-Amyloid 1-40 concentrations found in human cerebral spinal fluid (CSF) and combines those concentrations into a numerical ratio of β-Amyloid 1-42/ β-Amyloid 1-40 to estimate the presence of β-Amyloid neuritic plaque pathology in the brain.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of Lumipulse G β-Amyloid 1-42 and β-Amyloid 1-40 using the Lumipulse G System. The Lumipulse G β-Amyloid Ratio (1-42/1-40) results are intended to aid in the assessment of adult patients, aged 50 years and over, presenting with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. The Lumipulse G β-Amyloid Ratio (1-42/1-40) results must be interpreted in conjunction with other diagnostic tools such as neurological examination, neurobehavioral tests, imaging and routine laboratory tests.

A negative Lumipulse G β-Amyloid Ratio (1-42/1-40) result is consistent with a negative amyloid PET scan result. A positive Lumipulse G β-Amyloid Ratio (1-42/1-40) result is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. This test is not intended as a screening or stand-alone diagnostic assay. Fujirebio Diagnostics, Inc., looks forward to providing a commercially available in vitro diagnostic test to help in the assessment of Alzheimer’s Disease; a disease with 5.7 million afflicted Americans resulting in the 6^th leading cause of death in the United States www.alz.org .

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is a global leader in the field of high quality in vitro diagnostics (IVD) testing. It has more than 40 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio Diagnostics has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us as www.fujirebio-us.com.

Fujirebio Diagnostics is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544).

Media Contact

Hiroshi Sekiya

Fujirebio US, Inc.

Office: 484-395-5557

Hiroshi.Sekiya@fujirebio-us.com