MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News:
Like other laboratories, bioMérieux (Paris:BIM) has been summoned to appear before the Tribunal de Grande Instance de Paris by 45 patients to obtain compensations linked to anxiety allegedly “generated by a lack of reliability of serodiagnostic tests” for Lyme disease.
Committed to serving public health for more than 50 years, bioMérieux is particularly sensitive to the distress experienced by patients affected by the symptoms of this disease. The Company is committed to doing everything possible to provide answers to the technical questions it will be asked about its tests.
Like the other Elisa tests available in France for the diagnosis of Lyme disease, these assays are prescribed by physicians as a first-line diagnostic test in accordance with recommendations issued by national and international scientific experts.
The bioMérieux Lyme assays have always complied with, and continue to comply with, regulations in Europe and the United States. They meet the recommendations from several consensus conferences gathering experts at national, European and international levels.
bioMérieux considers that no fault was committed by the Company. It will oppose the demands of the subpoena, which, in light of available information, appears to be unfounded. Mr. Matthieu Brochier of the law firm Darrois Villey Maillot Brochier will provide legal counsel to bioMérieux. The Company deems that the impact of this civil case cannot be anticipated at this step of the procedure.
As current scientific debate attests to, Lyme disease is a particularly complex disease. Because clinical signs are nonspecific, it is essential to consider test results – which represent but one of the factors in detecting the disease – within the broader context of a medical examination.
bioMérieux is ready to share its expertise within the framework of the French national plan to fight against Lyme disease, in partnership with physicians, patient organizations, scientists and biologists, as well as the Ministry of Health and health authorities.
A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 42 subsidiaries and a large network of distributors. In 2015, bioMérieux’s revenues reached €1,965 million with 90% of international sales.
bioMérieux provides diagnostic solutions (reagents, instruments, software) 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 agri-food, pharmaceutical and cosmetic products.