bioMérieux launches a new assay for vitamin D testing: VIDAS® 25 OH Vitamin D Total

This new diagnostic test for the determination of vitamin D status, which has received CE marking, was developed and is produced by bioMérieux in France at its Marcy l’Etoile site, where the Company’s global headquarters are located. VIDAS® 25 OH Vitamin D Total is used on the VIDAS®, mini VIDAS® and VIDAS® 3 automated immunoassay platforms. With a reputation for quality and reliability, VIDAS® is the world’s largest installed base of automated immunoassay systems in clinical laboratories. VIDAS® 25 OH Vitamin D Total is a quantitative test using ELFA (Enzyme Linked Fluorescent Assay) technology.

“We are extremely pleased to enrich our VIDAS® menu with this new test, a welcome addition for the measurement of vitamin D status,” said François Lacoste, Corporate Vice-President of the Immunoassay Unit at bioMérieux. “Vitamin D deficiency can lead to a number of diseases in patients. For clinical laboratories, this test represents a useful new development to determine vitamin D levels with precision. Many clinical laboratories will now be able to perform vitamin D testing in-house, whereas currently they must send samples to reference laboratories. We plan to seek regulatory approval in other countries, especially the United States, as well as in emerging markets.”

VIDAS® 25 OH Vitamin D Total uses an immunoenzymatic method to measure vitamin D2 (25-hydroxyvitamin D2) and vitamin D3 (25-hydroxyvitamin D3) levels in human serum and plasma, providing extremely precise and rapid results (within 40 minutes).

Vitamin D is a hormone synthesized by the body when ultraviolet rays from sunlight strike the skin. Because it promotes the absorption of calcium and phosphate, vitamin D plays an essential role in the body. Vitamin D deficiency may cause rickets in children and secondary hyperparathyroidism and osteoporosis in adults, which may lead to a risk of bone fracture. In addition, recent studies have shown that low vitamin D levels may be associated with a risk of diabetes, cardiovascular and autoimmune diseases, as well as certain forms of cancer.(1-8) Today vitamin D is recognized for the many ways it contributes to maintaining good health. (9)

About vitamin D

Vitamin D is primarily available in two distinct forms: vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). Vitamin D3 is synthesized from 7-dehydrocholesterol through the action of solar ultraviolet rays on the skin. It is also found in food (primarily fatty fish). Vitamin D2 comes only from exogenous sources, and is found in small amounts in food (mushrooms, vegetables). These two forms of vitamin D (D2 and D3) may be taken as dietary supplements and are metabolized by the body in the same way.

About VIDAS®

With over 27,000 VIDAS® and mini VIDAS® systems used by clinical laboratory professionals, bioMérieux has the largest installed base worldwide of automated immunoassay systems. Around the world, three VIDAS tests are performed each second. These systems offer multi-parameter instruments using ELFA (Enzyme Linked Fluorescent Assay) technology, based on a ready-to-use single-sample test concept. The analyses may be run in a series or individually. Launched in 1992, the VIDAS product range has earned a reputation for quality and reliability. The VIDAS menu includes 99 parameters covering a wide range of human pathologies: identification and quantification of bacteria, viruses and parasites, antibodies measuring the immunological response to an infection and different proteins circulating in the blood, markers for selected cardio-vascular diseases and certain cancers, inflammatory response and hormonal dysfunction.

VIDAS® 3, the new generation of VIDAS®, was granted CE marking in June 2013. VIDAS® 3 features enhanced automation, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. This instrument is commercially available in Europe and the countries that recognize the CE marking. The Company plans to progressively obtain regulatory approval for commercialization in other countries, particularly the United States and China.

About bioMérieux

Pioneering diagnostics

A world leader in the field of in vitro diagnostics for 50 years, bioMérieux is present in more than 150 countries through 41 subsidiaries and a large network of distributors. In 2012, revenues reached €1,570 million with 87% of sales outside of France.

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 used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the NYSE Euronext Paris market. (Symbol: BIM - ISIN: FR0010096479).

Corporate website: www.biomerieux.com

Investor website: www.biomerieux-finance.com.

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2. DOBNIG H, et al. Independent association of low serum 25-hydroxyvitamin d and 1,25-dihydroxyvitamin d levels with all-cause and cardiovascular mortality. Arch Intern Med. 2008 Jun 23;168(12):1340-9.
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