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 specialises in the design and distribution of rapid tests (RDT). Biosynex is now the French market leader in this field.
Fast and easy to use, these tests are commercialized in France and in some 90 countries through local distributors. By targeting both the public and healthcare professionals, Biosynex provides concrete effective solutions to all the latest public health issues.
Since 2020, Biosynex has been at the forefront of the Covid-19 pandemic, offering innovative screening solutions (serology tests, antigen tests, self tests and PCR).
Self-tests are the general public version of RDTs (rapid diagnostic tests) 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 : THE ONLY ACTOR IN FRANCE TO MASTER THE ENTIRE CHAIN OF VALUE
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 products for which Biosynex is legal manufacturer meet the requirements of:
- the Directive 98/79/(EC) and in transition the European regulation (EU)2017/746 for IVDs (InVitro devices)
- the European regulation EU2017/745 for MDs (Medical Devices).
Compliance with CE marking requirements is verified according to the regulations in force for all products.