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Fujirebio Diagnostics is a premier global in vitro diagnostics (IVD) company specializing in the development and manufacturing of oncology biomarkers. Originally established as Centocor Diagnostics, the company was acquired by Fujirebio in 2006 and now serves as a key pillar of the H.U. Group Holdings. The company is widely recognized for its gold-standard assays, including the ROMA (Risk of Ovarian Malignancy Algorithm) and a broad portfolio of tumor markers such as CA125, HE4, and CA19-9. Beyond its own product line, Fujirebio Diagnostics is a leading contract development and manufacturing organization (CDMO), partnering with major diagnostic firms to produce high-quality clinical assays. With significant operations in the United States and Sweden, the company is also expanding its reach into neurodegenerative disease biomarkers, particularly for Alzheimer's disease.
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