Major Advances in the Early Detection of Neuro­degenerative Diseases

In 2025, Fujirebio Diagnostics became the first company in the world to receive approval from the U.S. Food and Drug Administration for a blood test used in the diagnosis of Alzheimer’s disease. In Mölndal, efforts are now continuing to develop tests for the early detection of other neurodegenerative diseases and cancers.
A researcher operating the Lumipulse® system, Fujirebio Diagnostics’ fully automated platform for high-sensitivity biomarker analysis. Photo: Fujirebio Diagnostics.
A researcher operating the Lumipulse® system, Fujirebio Diagnostics’ fully automated platform for high-sensitivity biomarker analysis. Photo: Fujirebio Diagnostics.

IThe international biotechnology company Fujirebio Diagnostics develops, manufactures, and commercializes medical devices for in vitro diagnostics (IVD), with a focus on tumor markers for the diagnosis, monitoring, and follow-up of patients with solid tumors, as well as biomarkers for diagnosing neurodegenerative diseases in cerebrospinal fluid and blood. The group operates across several business areas.

– We develop diagnostics using monoclonal antibodies, supply antibodies to world-leading medical technology companies within the diagnostics industry, and support the diagnostics industry in developing and manufacturing products for their testing systems, explains Christian Fermér, Managing Director at Fujirebio Diagnostics.
The CanAg Glypican-3 ELISA kit, developed for the early detection of liver cancer biomarkers, part of Fujirebio Diagnostics’ oncology portfolio. Photo: Fujirebio Diagnostics.

During the 2020s, Fujirebio Diagnostics has increasingly focused on diagnostics for neurodegenerative diseases, and in May 2025, the company made history when its Lumipulse® test became the first in the world to be approved by the FDA as a tool for diagnosing Alzheimer’s disease.

– A milestone that reinforces our position as a leader in diagnostics for neurodegenerative diseases. We are now making a major investment here in Mölndal to develop tests for other neurodegenerative diseases.

ALS and Parkinson’s Disease

In the development laboratory at the company’s new facilities in GoCo Health Innovation City, the R&D team is working on developing a new test for early diagnosis of Amyotrophic Lateral Sclerosis, a disease for which only symptomatic treatments are currently available.

– While research into future treatments is ongoing, improved early diagnostics are needed to help rule out other diseases. Although it is still early in the process, the outlook is very promising.
– We are also actively involved in the development of early diagnostics for Parkinson’s disease and have, over the past year, developed specific antibodies for this purpose.
Fujirebio Diagnostics’ researchers handling biological samples under controlled conditions in the development laboratory in Mölndal. Photo: Fujirebio Diagnostics.

The Swedish operations, which originated from a research project in 1980 aimed at developing a blood test for pancreatic cancer, are also leading in oncological diagnostics.

– We have developed a test for the early detection of Glypican-3, a protein that is highly overexpressed in liver cancer, which is a major issue in parts of the world. The test is available on our ELISA platform and will soon also be available on our fully automated Lumipulse® platform.
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Håkan Oltander
Håkan Oltander
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