Innogenetics, founded in 1985 in Gent (Belgium), is an established biotechnology company engaged in the discovery, development, and
marketing of diagnostic products for human healthcare, and in the discovery and development of therapeutic products.
The Company targets five disease areas: infectious disease, tissue repair, immune, neurodegenerative, and genetic disorders. In those
areas, the company focuses on selective markets where it can use its innovative technologies to offer high value-added products.
Innogenetics' goal is to build an innovative, international biomedical company characterized by a vertically integrated business in
diagnostics, and a partnering strategy in therapeutics.
Innogenetics is a research-driven biotech company, not only producing classic screening and diagnostic products, but an increasing
number of therapy monitoring tests and candidate therapeutics. This approach has led to original diagnostic product lines, such as the
line probe assay (LiPA) and the line immunoassay (LIA), and strong patent positions concerning the hepatitis C virus (HCV) and the
human immunodeficiency virus (HIV). Innogenetics discovered and owns the key patent on HIV-1 group O antigens.
The building of new state-of-the-art manufacturing facilities for diagnostic products is an important step towards the global
commercialization of these products.
Innogenetics has obtained ISO9001 and EN46001 certification for the development and production of in vitro diagnostic kits. The
certified body is Lloyd's Register of Quality Services.
Description of Products
Line probe assay (LiPA)
LiPA is a multiprobe, strip-based, detection system for DNA. A large number of targeted genetic characteristics, located in one or
more genes, can simultaneously be processed in a single patient sample. This allows the determination of specific recognition patterns,
which are representative for specific diseases or infections.
LiPA tests are based on the reverse-hybridization principle. Specific oligonucleotide probes are immobilized as parallel lines on
membrane-based strips. The patient's sample is submitted to PCR amplification with biotinylated primers. The amplified biotinylated
DNA material is then hybridized with the probes on the strip. After hybridization, streptavidin, labeled with alkaline phosphatase, is
added and bound to any biotinylated hybrid previously formed. Incubation with BCIP/NBT chromogen results in a purple/brown
precipitate. The banding pattern on the strip can then be interpreted.
LiPA products include assays for the detection of mutations in the reverse transcription (RT) gene of the HIV virus associated with drug
resistance, different assays for human leukocyte antigen (HLA) typing, and an assay for the detection of mutations in Mycobacterium
tuberculosis associated with rifampicin resistance.
Line immunoassay (LIA)
LIA is a multiparameter, strip-based system which is used for the detection of antibodies against antigens of infectious agents or for the
detection of autoantibodies.
Recombinant proteins and/or synthetic peptides are coated as discrete lines on a nylon strip with plastic backing. The test sample is
incubated in a test trough together with the multiple antigen-coated test strip. Specific antibodies, if present in the sample, will bind to the
individual antigen lines on the strip. Afterwards, a goat anti-human IgG labeled with
alkaline phosphatase is added and will bind to any antigen/antibody complex previously formed. Incubation with enzyme substrate and
the chromogen BCIP/NBT produces a dark brown color in proportion to the amount of specific antibody present in the sample. Color
development is stopped with sulfuric acid.
Examples of LIA products include assays for the confirmation of antibodies against HIV and differentiation between HIV-1 and HIV-2,
for the confirmation of antibodies against HCV, and for the detection of autoantibodies to anti-nuclear antigens (ANA). An assay for the
confirmation of antibodies against human T-cell lymphotropic virus (HTLV) and differentiation between HTLV-I and HTLV-II is
currently under development.
Products include assays for the detection of antibodies against HIV-1 and HIV-2 (this assay includes HIV-1 group O-specific
antigens), tests for the detection of antibodies against HCV, and assays for the detection of HIV-1 and HIV-2 antigens.
The biologicals produced at Innogenetics include antigens, monoclonal and polyclonal antibodies, as well as plasmid DNA. These
biologicals are either used in diagnostic test kits or for research purposes.
Innogenetics' research facilities consists of approximately 7,700 m² ( 77,000 sq.ft.) of working space. These premises are located in
Zwijnaarde, near Gent, Belgium on the site of an industrial park . In addition, the Company has 2,300 m² ( 23,000 sq.ft.) of facilities for
development, production, and quality control of diagnostic kits located in Zwijndrecht, near Antwerp (some 35 miles from its
Content and Size of Facility under Construction
In order to increase production capacity, centralize its various departments, and manufacture its products in compliance with the
different requirements of regulatory authorities worldwide, Innogenetics has opted to build a major new facility in close proximity
(approx. 1 mile) to its current headquarters in Zwijnaarde.
The project was launched in mid-1996 and is to result in the completion of a 3-story building with approximately 14,000 m² (140,000
sq.ft.) of space, fully operational by mid-1999. Actual construction work on the project was begun in August 1997. The following
major units will be located in the facility:
# Unit for medical diagnostic kits manufacturing (ground floor)
# Unit for development activities (first floor)
# Unit for biologicals manufacturing (second floor)
An adjacent office wing will have a total floor area of 2,650 m² (26,500 sq.ft.). The manufacturing area accounts for a total area of
11,200 m² (112,000 sq.ft.), of which 50% is taken up by laboratories containing approximately 3,200 m² (32,000 sq.ft.) of Clean
Innogenetics has chosen to locate its new facility in Zwijnaarde at the Technology Park of the University of Gent.