bioMérieux

Regulatory Filings • Apr 7, 2021

bioMérieux announces the CE marking of 3 dengue immunoassays on VIDAS®

Marcy l'Etoile, France – April, 7 th 2021 –bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its innovative and fully-automated assays to diagnose dengue infection:

• VIDAS® DENGUE NS1 Ag
• VIDAS® Anti-DENGUE IgM
• VIDAS® Anti-DENGUE IgG

Dengue is a viral disease transmitted to humans by certain types of mosquitoes. With 100 to 400 million people affected each year, it is the most common arthropod-borne viral infection worldwide. The global incidence of this infection has grown over 8 fold during the last 20 years, with the greatest burden observed in Asia (75%) followed by Latin America and Africa (1-2).

Dengue often presents non-specifically and with fever, thereby leading to a high risk of misdiagnosis in the absence of laboratory confirmation, especially in countries where many other infectious diseases are circulating. "Presenting in different forms, from mild to life-threatening, a dengue diagnosis and optimal patient management both rely on rapid and reliable diagnostics. In line with our goal of addressing major global health issues, it is important for us to provide these easy, automated, and high-quality tests for diagnosing dengue virus infection." said Mark Miller, Executive Vice President, Chief Medical Officer, bioMérieux.

Diagnostic testing for dengue relies on several laboratory methods, mainly manual, which each have their own advantages and limitations. If molecular assays are not available or the patient presents later during the course of the disease, serological methods are particularly well suited (3-5).

VIDAS® DENGUE NS1 Ag, Anti-DENGUE IgM and Anti-DENGUE IgG are the new automated assays intended as an aid in the diagnosis of dengue infection.

These VIDAS® DENGUE assays can be used independently to detect the viral antigen (NS1) and antibodies (IgM and IgG) produced by the host in response to the infection. These 3 serological tests are recommended by international guidelines (6).

Performed on the VIDAS® family platforms, VIDAS® DENGUE assays provide reliable results with improved quality compared to the existing manual methods. The performance level responds to the medical need for an early and accurate diagnosis of dengue.

The test process is fully automated, from sample identification to the result report. Based on the single test concept and the "load & go" system, the VIDAS® DENGUE panel is easy to use and accessible to all laboratories. Capitalizing on bioMérieux's expertise in infectious diseases, VIDAS® DENGUE assays enable clear-cut results with no equivocal zone and an objective interpretation thanks to the automation.

"This new VIDAS® DENGUE solution is cost-effective and suitable for low- and middleincome countries where VIDAS is widely available. It broadens our immunoassay offer against vector borne-diseases that will be further extended to chikungunya" said Pierre Boulud, Chief Operating Officer, Clinical Operations, bioMérieux.

ABOUT VIDAS®

Launched 30 years ago, VIDAS® has transformed the field of immunoassays offering laboratories universal access to a simple, automated and robust technology providing fast and reliable results. Today, VIDAS® is still the most widely used immunoassay system in clinical laboratories worldwide.

The VIDAS® menu covers a wide range of pathologies, including infectious and chronic diseases and a range of tests dedicated to emergency and critical care. A number of these parameters are part of the bioMérieux full solution to address the global challenges of antimicrobial resistance (AMR) and sepsis. As it enters into its fourth decade, VIDAS® remains a major focus of the bioMérieux immunoassay strategy with ongoing research into new parameters and frequent launches that create value for labs and clinicians, for the benefits of the patients.

ABOUT BIOMÉRIEUX

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2020, revenues reached €3.1 billion, with over 90% of international sales.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agrifood, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market. Symbol: BIM – ISIN Code: FR0013280286 Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com.

REFERENCES

• 1. Wilder-Smith A, Ooi E-E, Horstick O, Wills B. Dengue. The Lancet. 2019;393(10169):350-63. 2. WHO. Dengue and severe dengue. Fact sheets. [cited 2021 March 31]. Available from:
• https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue. 3. Raafat N, Blacksell SD, Maude RJ. A review of dengue diagnostics and implications for surveillance and control. Trans R Soc Trop Med Hyg. 2019;113(11):653-60.
• 1. Muller DA, Depelsenaire AC, Young PR. Clinical and Laboratory Diagnosis of Dengue Virus Infection. J Infect Dis. 2017;215(suppl_2):S89-S95.
• 1. Peeling RW, Artsob H, Pelegrino JL, Buchy P, Cardosa MJ, Devi S, et al. Evaluation of diagnostic tests: dengue. Nat Rev Microbiol. 2010;8(12 Suppl):S30-8.
• 6 WHO, CDC, HAS, PAHO dengue testing recommendations.

CONTACTS Investor Relations bioMérieux Franck Admant Tel.: + 33 4 78 87 20 00 investor.relations@biomerieux.com

Media Relations bioMérieux Image Sept Romain Duchez Laurence Heilbronn Claire Doligez Tel.: + 33 4 78 87 20 00 Tel.: + 33 1 53 70 74 64 Tel.: + 33 1 53 70 74 48 media@biomerieux.com lheilbronn@image7.fr cdoligez@image7.fr