Corporate Development

// founded 1998

// Technology Campus Berlin Buch



  • By the end of the year, CONGEN had produced more than 10 million SARS-CoV-2 PCR tests, making an important contribution to the health system
  • As on of the first manufacturers CONGEN developed a real-time PCR System for the detection of Coronavirus SARS-CoV-2


  • AOAC/ Microval validation for Salmonella detection including rapid extraction method
  • Succesful reaccreditation according to DIN EN ISO 17025:2005
  • Succesful recertification according to DIN EN ISO 9001:2015


  • Succesful recertification according to DIN EN ISO 13485
  • Certified VLOG lab (GMO free labeling)
  • Servicelab move to new and from production seperated laboratories in house 80
  • First 510(k) Premarket Notification (PMN) for Norovirus genogroup detection kit
  • Start of product sales for personalized medicine
  • Rebuilding and expansion for planed FDA approval regarding special detection kits for clinic parameters and Norovirus


  • Development of detection kits in the field of personalized medicine
  • Award “Innovative through Research” by the German Stifterverband


  • DIN EN ISO 13485 certification – development, production and distribution of molecular biological test systems for clinical diagnostics
  • Development of the first 5plex real-time applications for clinical diagnostics
  • Exit of Dr. Kuhn from the operative business
  • 30 employees


  • R-Biopharm acquire GmbH-shares
  • First external product validation of AOAC/Microval


  • Start of product sales for clinical diagnostics
  • Development of the first 4plex real-time applications


  • Start of product development for clinical applications


  • DIN EN ISO 17025 accreditation (competence of testing and calibration laboratories)
  • Reorientation towards real-time PCR products with hydrolysis probes (TaqMan)


  • ISO 9001 certification (quality management system)
  • Distribution via R-Biopharm


  • Opening of the laboratory and beginning of development work for applications in the fields of GMO, animal species and allergens


  • Founding of CONGEN Biotechnologie GmbH by Dr. M. Kuhn and Dr. S. Mergemeier
  • 3 employees