The Quality League of Immunodiagnostic Components
DIARECT AG is a privately owned biotech company with over 20 years expertise in developing and establishing standardized large-scale productions of both recombinant and native proteins, including their worldwide distribution. Providing customers with products and services of consistent quality is the cornerstone of DIARECTs business philosophy.
DIARECT is not only a leading manufacturer of autoimmune and infectious disease antigens, but also of recombinant and native purified allergens. The most recent additions to the product portfolio were modified autoimmune disease antigens and human chimeric antibodies to be used as standards or positive controls. In addition, DIARECT is the exclusive distributor of Surmodics in Europe. With Surmodics' protein stabilization reagents, blockers and BioFX substrates, DIARECT is able to provide most of the critical components for the development of diagnostic end products.Research & Development
Since its founding, DIARECT has been involved in numerous product innovations:
- First thyroid peroxidase antibody test system, based on recombinant TPO
- First ANA/ENA profile and screening assay, utilizing several recombinant proteins
- Introduction of symmetrically dimethylated recombinant SmD proteins
- Supply of antigens for the detection of rare antibodies, e.g. EJ, KS, MDA5, TIF1 gamma
- Supply of biotinylated autoimmune disease antigens
- Large-scale production of human chimeric autoantibodies
- Most complete panel of recombinant tick-borne disease antigens
- Development of purified native and recombinant allergens for component-resolved diagnostics
Driven by the commitment to further expand its range of products, DIARECT will continue the development of new and innovative products in the years to come.ISO Certification
High quality has always been the key criterion for DIARECT products. As a high-grade key component manufacturer and provider, DIARECT realized our customers needs very early and first implemented a quality management system certified according to ISO 9001 in 2002, followed by ISO 13485 standards in 2008. DIARECT is dedicated to provide our customers the best services in all aspects of our business, particularly the design, development, manufacturing and distribution of raw materials and intermediates for IVD devices (autoimmune and infectious disease antigens, allergens, antibodies).