GENT, Belgium & MALVERN, Pa. & TOKYO--(BUSINESS WIRE)--#IVD--H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G NfL CSF and Lumipulse G NfL Blood assays for the fully automated random-access LUMIPULSE^� G immunoassay systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative measurement of Neurofilament light (NfL) in human Cerebrospinal fluid (CSF) and plasma/serum, respectively, within just 35 minutes. The two assays are available for Research Use Only.

�In 2022, we introduced three fully automated blood-based assays for the detection of pTau181, ?-Amyloid_1-42 and ?-Amyloid_1-40, and we are now proud to once again expand our neurodegenerative disease portfolio with the highly anticipated NfL biomarker,� Christiaan De Wilde, CEO of Fujirebio Europe and Global Head Neuro Business. �The assay menu offered by other industry leaders today is still limited and we are working diligently to create a solid lineup of tests for the entire neurodegenerative disease field as quickly as possible.�

The new biomarker tests will allow researchers and clinical research professionals across the world to further study the clinical utility of NfL in diverse disease conditions such as multiple sclerosis, amyotrophic lateral sclerosis, frontotemporal dementia, Parkinson�s, or Alzheimer�s disease as well as in acute situations such as traumatic brain injury. NfL is considered a promising biomarker for disease activity, progression, prognosis, and monitoring effectiveness of therapies.^1-4

Laboratory professionals can select their preferred specimen matrix and measure NfL on the fully automated, random-access LUMIPULSE G platform. This standardized immunoassay system family is widely available and used in routine labs active in the field of neurological diseases with its current assay menu. The LUMIPULSE G platform meets the necessary throughput, quality, and regulatory requirements to support possible future routine use of NfL in addition to the existing portfolio.

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 AD 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/neuro.

References

1. Yuan A, Rao MV, Veeranna, Nixon RA. Neurofilaments and Neuro-filament Proteins in Health and Disease. Cold Spring Harb Perspect Biol. 2017 Apr 3;9(4):a018309.
2. Gaetani L, Blennow K, Calabresi P, Di Filippo M, Parnetti L, Zetterberg H. Neurofilament light chain as a biomarker in neurological disorders. J Neurol Neurosurg Psychiatry. 2019 Aug;90(8):870-881.
3. Thebault S, Booth RA, Freedman MS. Blood Neurofilament Light Chain: The Neurologist�s Troponin? Biomedicines. 2020; 8(11):523.
4. Yuan A, Nixon RA. Neurofilament Proteins as Biomarkers to Monitor Neurological Diseases and the Efficacy of Therapies. Front Neurosci. 2021 Sep 27;15:689938

Contacts

For media:

Public Relations Section, Public Relations/Sustainability Department,

H.U. Group Holdings, Inc..

Phone: +81-3-6279-0884

E-mail: [email protected]

Christiaan De Wilde

CEO Fujirebio Europe

Phone: +32 9329 1703

For investors and analysts:

IR/SR Dept.

Phone: +81-3-5909-3337

E-mail: [email protected]