Innogenetics N.V. (now Fujirebio Europe N.V.) is an international in vitro diagnostics (IVD) company, with headquarters in Ghent, Belgium. The company develops and markets IVD testing solutions from specialized manual testing to fully automated routine testing that cover areas such as infectious diseases, oncology, genetic testing, thyroid, fertility, tissue typing, neurodegeneration and bone. The company was acquired in September 2010 by Japanese Fujirebio Inc., part of Miraca Holdings Inc., and changed name to Fujirebio Europe on October 1, 2013. The CEO of Fujirebio Europe N.V. is Christiaan De Wilde.
Innogenetics was founded on 18 July 1985, by Erik Tambuyzer, Hugo Van Heuverswyn and Rudi Mariën. In 1992, the company launched the first commercial tests for cystic fibrosis in Europe (INNO-LiPA CFTR) and in 1993 the first commercial test for Hepatitis C virus (HCV) genotyping worldwide (INNO-LiPA HCV). In 1995, the first commercial Alzheimer's disease research test for hTau was launched (INNOTEST hTau Ag). In 1998, the company launched the first commercial Alzheimer's disease research test for β-Amyloid and in 2002 the first commercial test for Hepatitis B virus (HBV) genotyping (INNO-LiPA HBV Genotyping).
The company was one of the first biotech companies to be listed on a European stock exchange, in 1996 it was the first biotech company listed on EASDAQ, now NASDAQ Europe. Until 2008 Innogenetics had its shares traded on Euronext Brussels.
Innogenetics N.V. was acquired by Fujirebio Inc., a Japanese daughter company of Miraca Holdings Inc., in 2010 and changed name to Fujirebio Europe N.V. on October 1, 2013.
Its products in the area of infectious diseases include screening and confirmation tests for HIV, HCV, HTLV and syphilis; genotyping tests for HCV, HBV, HPV and mycobacteria; and drug-resistance tests for TB and HBV. Innogenetics also offers genetic testing products for cystic fibrosis associated with genetic risks; tissue typing tests to determine the type of HLA; and neurodegeneration products including biomarkers for Alzheimer's disease. In the oncology area the company offers typing assays for detecting HR and LR papilloma virus as well as quantitative determination of hPLAP.
The company's main long-standing IVD product ranges are INNO-LiPA, INNO-LIATM, INNOTEST® and INNO-BIA and automation of LIA and LiPA can be done on the Auto-LIPA 48, Auto-LIATM 48, AutoBlot 3000H and AutoBlot 3000 platforms. In November 2011 Innogenetics also launched the Fujirebio-produced LUMIPULSE® G1200, a mid-sized and fully automated chemiluminescent enzyme immunoassay (CLEIA) system, on the European market.
It has collaborative research, development, distribution, or licensing agreements with (non-exhaustive list): Abbott Diagnostics Inc., Diasorin S.p.A., Eli Lilly, GenMark Diagnostics Inc., GlaxoSmithKline Biologicals, Hologic Inc. (formerly Third Wave Technologies Inc.), Immuno-Biological Laboratories Co. Ltd, Luminex Corporation, Quest Diagnostics Inc. (formerly Athena Diagnostics Inc.), Roche Group of Companies, Siemens Healthcare Diagnostics (formerly Bayer HealthCare LLC) and Takeda Chemical Industries, Ltd.
Its products are sold worldwide through its 6 subsidiaries and a large number of distributors. It is also member of the EDMA (European Diagnostic Manufacturers Association), the trade association that represents the IVD industry active in Europe.
- Jannes G, De Vos D., A review of current and future molecular diagnostic tests for use in the microbiology laboratory, Methods Mol Biol. 2006;345:1-21.
- Tortoli E, Marcelli F., Use of the INNO LiPA Rif.TB for detection of Mycobacterium tuberculosis DNA directly in clinical specimens and for simultaneous determination of rifampin susceptibility, Eur J Clin Microbiol Infect Dis. 2007, Jan;26(1):51-5.