德国Analyticon Biotechnologies www.analyticon-diagnostics.com
Analyticon® Biotechnologies AG manufactures tests for human medical diagnosis, with approx. 83 employees in two facilities in the North of Hesse in Germany.
Our philosophy:
„Standard for highest Quality“
has caught on also outside Germany:
Based on a worldwide network of dealers and branch offices, we are distributing our products all over the world, meeting the requirements of the German Medical Product Law and the RiliBÄK as well as the standards of the US Food and Drug Administration (FDA) and the Chinese inspectorate SFDA.
All Products are manufactured in line with the GMP and DIN ISO 13 485 rules. We guarantee for a complete quality control, covering development, production and sales.
Analyticon®´s R&D continuously expands its product portfolio and at the same time keeps the quality of its IVD product offer at the highest level by regular product enhancements and perfective maintenance. The main activities are in line with Analyticon®´s core competence in the field of rapid tests which are focussing on the development of new point of care tests (POCTs) for their use by medical professionals and POCTs for self-/home testing, as strips and dipsticks. The envisaged biomarkers cover a broad range of clinical applications:
Pregnancy tests
Ovulation tests
Diabetes
Cardiac markers
Tumor markers
Infectious diseases
Drugs of abuse tests
The tests under development are based on a proprietary methodology using synthetic nucleic acids or other comparable docking molecules as highly specific binders for individual biomarkers which act as molecular switches depending on the presence or absence of the respective marker molecule. This methodology, for which Analyticon® has filed patent, promises technical and economic advantages for POCT tests compared to the products that are currently available in the IVD market without accepting any compromise in the quality. A further benefit of the methodology is its modular concept which simplifies the assay development for new biomarkers. Diagnostical test systems based on synthetic nucleic acids have also potential to serve as basis for a therapeutic approach in the corresponding disease area. In parallel, so-called fast-track specific binders are used in the short-term programs. Since most of the POCT assays are developed in solution in the first step, Analyticon® also expects to establish the corresponding clinical chemistry tests in parallel for some of the biomarkers.