Eurobio Scientific gets CE marking for its proprietary COVID-19 test
Paris, March 25, 2020 – 5:45pm
Eurobio Scientific (FR0013240934, ALERS, PEA-PME eligible), a leading French group in the field of specialty in vitro medical diagnostics, is today announcing the CE marking for its EBX 041 SARS CoV2 proprietary test, developed specifically for the clinical diagnosis of COVID-19.
The EBX 041 SARS CoV2 proprietary kit follows the design recommended by the French National Reference Center (CNR) and has been approved based on clinical samples with an independent hospital. This is a multiplex kit with three targets: two for identifying the virus and one target for a control integrated into each patient test.
The test is being produced in-house by Eurobio, at its recently renovated Les Ulis facility, following the regulatory standard process ISO 13481. Its production capacity represents over 200 kits of 96 tests each, for a total of nearly 20,000 tests per day, with the capacity to triple this volume in line with demand.
This is a multiplexed real-time PCR* test that can be used directly on a large number of open thermal cycler instruments, present in diagnostic laboratories. After extraction, it makes it possible to rapidly detect (1h15) the genes identifying the SARS COv2 virus, as recommended by the World Health Organization (WHO).
Alongside this, Eurobio Scientific is continuing to distribute the ALLPLEX™ CORONAVIRUS panel developed by its South Korean partner SEEGENE™, for which it is the exclusive distributor in France. With nearly 60 laboratories and technical platforms in France (public and private), the order book (sales + orders) for these tests and related instruments represents approximately €5m to date.
The company remains organized, in the current epidemic context, to produce and deliver in line with demand from both hospital and private laboratories.
Denis Fortier, General Manager of Eurobio Scientific: “I would first of all like to thank our teams, our partners and our client laboratories for their continued mobilization in difficult conditions. Diagnosis is a key resource in the fight against the Coronavirus epidemic and our mission is to do everything possible to ensure that this resource is efficient, effective and available in sufficient quantities to support patients. Eurobio Scientific is also ready for the next diagnostic phase, which will involve testing immunity on a wide scale, with serological testing”.
* The Polymerase Chain Reaction (PCR) is a method based on selectively multiplying target DNA sequences, which makes it possible to detect specific DNA sequences present in a sample.
Next Financial Meeting
2019 annual results: April 14, 2020 (after market close)
|About Eurobio Scientific
Eurobio Scientific (ex Diaxonhit) is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 120 employees and two production units based in the Paris region and in the United States.
For more information, please visit: www.eurobio-scientific.com
The company is publicly listed on the Euronext Growth market in Paris
|Eurobio Scientific Group
Denis Fortier, General Manager
Hervé Duchesne de Lamotte, General Manager
Tel. +33 1 69 79 64 80
Mathieu Calleux / Gregory Bosson
Tel. +33 1 53 65 68 68 – firstname.lastname@example.org