Diagnostic Systems

Departments

PharmGenomics GmbH stands for interdisciplinary research and development. The company unifies employees from the areas biology, bioinformatics/informatics and quality management allowing for a close and well balanced cooperation of the different fields. Thereby every project is revised from design to final development in all relevant areas to identify weak spots and to meet all agreed requirements. For example any in-house developed software is not only tested by the computer scientists but also by the users, e.g. the biologists in the lab.

The following websites introduce the individual departments of our company:

Academy

Since several years the PharmGenomics GmbH deals with clinical analyses and research projects in the fields of pharmacogenetics and individualized therapies. Since 2010 we commit ourselves to education and training and therefore founded the PharmGenomics academy. We offer a wide range of training and courses for physicians, scientists and laboratory personnel.

 

Quality Management Seminars

  • DIN EN ISO 9001
  • DIN EN ISO 15189
  • DIN EN ISO 13485
  • DIN EN ISO/IEC 17025

Molecular Biological Work

Diagnostic Laboratory

The diagnostic laboratory is our company’s youngest department resulting from the successful developmental work of the last few years. Here we offer a genotyping-service based on the PGx GenoChip technology or real-time PCR, depending on our customers’ demands and needs.

The department is led by Dipl. Ing. This e-mail address is being protected from spambots. You need JavaScript enabled to view it. , who has a long lasting experience in all applied technologies and the careful handling of human samples.

We set high value on a fast and precise processing of every order and the appropriate handling of samples and data entrusted to us. For this purpose our bioinformatics department developed a customized software engaging every step from sample arrival over processing up to the final diagnostic report in one system.

For more information check our  product catalogue under PGx GenoChip and Service Laboratory or  This e-mail address is being protected from spambots. You need JavaScript enabled to view it. us directly.

 

Quality Management

Quality management serves as an important instrument for lasting effectiveness and efficiency in the context of realizing processes of varying forms.

New technological developments and guidelines strengthen the awareness for quality, competency and transparency in the performance of various tasks and document the perception of the private sector as a provider of quality-assured products and services. Through the social responsibility of PharmGenomics GmbH the quality policy is based on “Guidance on social responsibility” (DIN ISO 26000:2011).

Considering the demands on genetic diagnostic laboratories and in-vitro-diagnostics manufacturers, the PharmGenomics GmbH established a quality management system based on good professional practice and according to international standards (i.e. DIN EN ISO 9001:2008, DIN EN ISO 13485:2010, DIN EN ISO 15189:2007 und DIN EN ISO/IEC 17025:2005), directives (i.e. 98/79/EG, Directives of the genetic diagnostic commission and the German Federal Medical Council) and guidelines (i.e. S2-guideline human genetic diagnostics). The QM-system relies on the eight fundamental quality management principles: customer orientation, leadership, inclusion of the employees, process approach, system-oriented management approach, continuous improvement, factual approach to decision making and mutually beneficial supplier relationships. The current Quality Management Handbook is available on request.

External quality evaluations measures, so called round robin tests, complement the quality management of PharmGenomics GmbH as further verification control. Round robin tests are used to review the applicability/efficiency of methods and test-systems and to determine the competency of the diagnostic laboratory.

We strictly follow the guidelines of the German Federal Medical Council for the quality assurance of medical laboratory tests (RiLiBÄK).

View the current certificates of our successful participation in round robin tests.

PharmGenomics has met the demands for the following examinations:

  • Faktor V (Leiden)
  • Faktor II 20210
  • MTHFR
  • PAI-1
  • CETP
  • GP IIIa (L33P)
  • TPMT
  • CYP2D6
  • ALDO B
  • UGT1A1
  • HFE
  • DPD Exon 14 skipping (*2A)
  • LCT T-13910C

Quality management representative: Dipl.-Biol. This e-mail address is being protected from spambots. You need JavaScript enabled to view it. .

Research and Development

The department research and development of the PharmGenomics GmbH focuses on products in the field of genetic diagnostics. We pay special attention to pharmacogenetic markers from different areas, among others oncology, with the aim for personalized therapies.

Since various mutations in the human genome can impact the efficacy of drugs, we work on the development of quick, robust and precise tests for the detection of these gene modifications (genotyping). Thereby it is possible to screen the genes responsible for drug metabolism even before starting the therapy. By this an accurate  therapeutic decision, adapted to the needs of the individual patient, can be made to avoid side effects and to ensure a treatment as efficient as possible. Furthermore, we deal with several mutations linked to various food intolerances.

For our special demands we developed and patented the PGx GenoChip technology relying on DNA-Macroarray-technology that allows for a fast, safe and cost-effective detection of many gene variants in one assay.

On the basis of this detection platform it is possible to establish tests for many mutations asked for by clinicians.

Depending on the individual question of our costumers we develop, basing on our PGx GenoChip technology, a multiplex-assay adapted to the particular problem to allow a cost-effective and fast diagnostic. Production and validation are carried out according to high quality standards (DIN EN ISO 13485). We provide all suitable documents for a standard-compliant CE-labeling.

 

Read more about further offers and questions concerning the order of individual development or contact us directly.

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