Biosynex develops, manufuactures, and markets medical devices for screening, diagnosis and prevention in a constant quest for excellence. These simple, easy to use tests are used by health professionnals to facilitate the care of patients, and by the general public so that everyone can monitor their health. In this way we contribute to better PUBLIC HEALTH at all stages of life.
Who are we?
Located in Strasbourg (France), the BIOSYNEX Company was born in 2005 and is specialized in the design and distribution of rapid diagnostic tests (RDT). Today, BIOSYNEX is the leader of the RDT French market.
Fast and easy to use, these RDTs are commercialized in France and in some 70 countries through local distributors. By targeting the general public and health professionals, BIOSYNEX brings concrete and effective answers to public health issues at the heart of today’s preoccupations.
Self-tests are the general public version of RDTs and are available in pharmacies. These allow self-monitoring for multiple applications, such as: HIV, pregnancy diagnosis, ovulation period, male fertility, urinary tract infections, vaginal infections, etc.
RDTs may be used by health professionals (analytical laboratories, doctors) for diagnostic orientation. They allow an appropriate management of the patient both in consultation and in emergency. As an example, BIOSYNEX has been supplying around 50,000 liberal doctors with a strep test, Streptatest® for the last few years as part of the call for tenders launched by the National Health Insurance Fund for Employees (CNAMTS), this improving significantly the screening for bacterial angina and limiting the overconsumption of antibiotics.
RDTs may also be used in the analytical laboratory for the realization of piecemeal tests.
BIOSYNEX also commercializes a panel of instruments and machines which can be used in POC, as well as other tests for analytical laboratories based on technologies for confirmation diagnosis such as immunoblotting or molecular biology.
BIOSYNEX provides each distribution channel (biology laboratories, medical analysis laboratories, hospitals, pharmacies, hyper and supermarkets, etc) with a wide range of adapted products.
BIOSYNEX focuses its development and distribution choices on market-specific, world-class niches through home-made products with high added value (RDTs, women’s health, treatment monitoring, medical assistance, etc).
In order to maintain its position, BIOSYNEX opted for a proactive intellectual property protection policy by filing its own patents, which guarantees its role as an innovative player in the biology sector.
In order to improve its performance and productivity, BIOSYNEX integrates all the necessary know-how from the conception to the commercialization of its products in France and abroad :
- Marketing / Communication
- Quality / Regulatory
- Administration / Finance
Product compliance is the responsibility of the Quality / Regulatory unit.
BIOSYNEX has obtained the ISO 9001v2015 and ISO 13485v2016 certifications.
The complete quality assurance system has been declared in accordance with :
- European Directive 98/79/EC Annex IV.3 on in vitro diagnostic medical devices for the design, development, production and distribution of pregnancy and ovulation tests for self-diagnosis.
- Directive 93/42/EC, Annex V.3 on medical devices in order to be able to issue the CE mark and to appear as a manufacturer in the field of thermometers and tensiometers.