EUROBIO SCIENTIFIC obtains CE marking for its proprietary test for Covid-19 screening and detection of the Omicron and Delta variants

Eurobio Scientific obtains CE marking for its proprietary test for Covid-19 screening and detection of the Omicron and Delta variants

• Routine COVID screening test simultaneously detecting the presence of the Omicron variant and screening for other variants
• First French CE marked test requiring only one reaction and delivering a result in 45 minutes

Paris, December 13, 2021 – 6:00pm

Eurobio Scientific (FR0013240934, ALERS, PEA-PME eligible), a leading French group in specialty in vitro medical diagnostics, announces the CE marking of its proprietary test EBX 047, Eurobioplex SARS-CoV-2 Fast-SVD - Screening and Variants Detection, developed specifically for the routine screening of COVID-19 and the identification of current variants. This marketing authorisation comes less than 15 days after the launch on November 30^th, of a first RUO (Research Use Only) version of this test.

The EBX SARS-CoV-2 Fast-SVD proprietary test follows the design recommended by the French National Reference Center and was expanded compared to its first version. It is a multiplex PCR * kit to identify the presence of the SARS-CoV-2 virus, and qualitatively distinguish between several mutations: K417N (screening of the Omicron and Beta variant), E484K (screening of the Beta and Gamma variant) and L452R (screening of the Delta variant). The presence of the K417N mutation without the E484K mutation also makes it possible to differentiate the Omicron variant from the Beta variant and to screen the Omicron variant.

This new test, designed and developed by Eurobio Scientific's R&D team, is produced in-house, at its premises in Les Ulis - France, and follows the ISO 13485 regulatory standard process. It is available in several versions to perform 48, 96 or 192 tests.

EBX SARS-CoV-2 Fast-SVD is available immediately for hospitals and private laboratories, both in France and internationally.

* The "Polymerase Chain Reaction" (PCR) is a method based on the selective multiplication of target DNA sequences, which makes it possible to detect specific DNA sequences present in a product.

Next financial meeting
2021 FY revenues: 24 January 2022

Disclaimer
This press release contains elements that are not historical facts including, without limitation, certain statements about future expectations and other forward-looking statements. Such statements are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, profitability or events to differ materially from those anticipated. In addition, Eurobio Scientific, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications. Such statistical data and predictions are used in this press release for information purposes only. Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.

About Eurobio Scientific

Eurobio Scientific 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 164 employees and three production units based in the Paris region, in Germany and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany and Utrecht in The Netherlands.

For more information, please visit : www.eurobio-scientific.com

The company is publicly listed on the Euronext Growth market in Paris
Euronext Growth BPI Innovation, PEA-PME 150 and Next Biotech indices, Euronext European Rising Tech label.

Symbol: ALERS - ISIN Code: FR0013240934 - Reuters: ALERS.PA - Bloomberg: ALERS:FP

Contacts

 

Group Eurobio Scientific Denis Fortier, General Manager Hervé Duchesne de Lamotte, General Manager Tel. [phone]

Calyptus Mathieu Calleux / Gregory Bosson Investors relations Tel. [phone] [e-mail]

 

Attachment

• 211213_Eurobio_Variant_omicron_CE_EN

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