GENSPEED Biotech is a leading partner in Demo Case 2 (Molecular Diagnostics for Sars-CoV-2). Its tasks involve compatibility testing of microfluidic chips, as well as implementing a quality control system for large scale manufacturing of IVD chips for molecular diagnostics.
GENSPEED Biotech GmbH (GSB) is a ISO 13485 and ISO 9001 certified biotech company with currently 14 employees focussing on the development, production and distribution of rapid tests based on the proprietary GENSPEED technology platform. The product portfolio includes chairside tests for rapid detection of key pathogens in periodontitis, rapid tests for detection of all essential pathogens and respective resistances in nosocomial infections, as well as rapid tests for COVID-19 in laboratory quality. A production facility for IVD – CE approved products (7 brought to the market since 2012) has been established. GSB distributes via distribution partners to 30 partners worldwide.
Expertise: GSB has extensive know-how in DNA/RNA/Protein-microarray technology for detection and identification of microorganisms (bacteria and viruses) e.g. from swab samples but also for rapid detection of various biomarkers from blood, urine or saliva.
The GSB team developed from scratch the microfluidic chip-based test system named GENSPEED. The system utilizes chemiluminescence signal detection technology and passively driven microfluidics. GSB possesses extensive experience in design of microfluidics, optical detection, sample preparation and assay development (according to ISO 13485), including the optimization of signal amplification, sensitivity and time-to-diagnosis parameters. Background is from microbiology, molecular biology, biochemistry and biophysics. GSB has gathered extensive knowledge with regards to ISO 13485 compliant development of hardware (e.g. ISO 61010), software (e.g. 62304) and IVD assays.