Company

English: Research and Development at QIAGEN in Hilden, Germany. German: Forschung und Entwicklung bei QIAGEN in Hilden.

Biotype GmbH develops, manufactures and distributes molecular diagnostic kits for the detection and quantification of RNA and DNA markers. The assays support diagnosis and therapy in oncology, hemato-oncology, dermatology and forensics. Biotype also provides custom development & manufacturing of molecular diagnostic kits. We design and realize molecular assays on various platforms ranging from a prototype via RUO to CE-IVD. The company’s goal is to provide customers, such as laboratories, pharmaceutical, and diagnostic companies, with safe and robust molecular genetic tools.

All our tests are PCR-based and run either on commercial qPCR devices or on our Modaplex device. The Modaplex system provides a novel real-time quantification procedure through the unique combination of PCR and simultaneous capillary electrophoresis. This technology enables the examination of up to 2,000 DNA/RNA targets in one run. With little hands-on time and a simple workflow it allows to detect all types of genetic aberrations.

Company profile

  • Foundation – 1999
  • Management Dr. Wilhelm Zörgiebel, Dr. Karim Tabiti
  • Location – Dresden, Germany, GebäudeEnsemble Deutsche Werkstätten Hellerau
  • Activities – Applied research and development, production, and distribution
  • Facilities – 1000 m² composed of high-tech molecular biology labs with DNA, biochemistry and microbiology departments, as well as cleanrooms and office space

 

Quality Assurance

certification_badge_9001_13485Biotype is certified to meet DIN EN ISO 13485 and DIN EN ISO 9001 standards for the scope of sales, development, manufacturing and services of molecular tests for in-vitro diagnostic applications (ISO 13485:2016) and research and diagnostic applications (ISO 9001:2015).

The established quality management system ensures that the products and services meet all customer and regulatory requirements. Thereby, the company is able to provide its customers highest quality standards.

 

The certificates can be downloaded here:

ISO 13485 Certificate

ISO 9001 Certificate