Medical Device Daily
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Strong 4Q instrument sales helped bioMérieux (Marcy L’Etoile, France) finish 2007 with a 7.4% increase in sales from organic growth and an additional 0.5% growth in sales due to acquisitions.

Total sales for this growing giant in in vitro diagnostics were €1.06 billion ($1.59 billion) a bare 2.5% greater than 2006 due to unfavorable exchange rates against with a strong Euro worldwide.

Using a like-for-like method for measuring sales to exclude effects of expansions, acquisition and other events, bioMérieux showed a 10.2% increase in North American sales, for example, where pure reporting of sales revenues showed a decline of 2.3%.

All regions of the world showed organic growth like-for-like in 2007, with Asia-Pacific reporting a 12% increase and the region embracing Europe, the Middle East and Africa (EMEA) reporting a 5.6% increase.

Discounting a modest growth in France, the rest of the EMEA region turned in an overall increase of 7.8%, chiefly in Germany and the UK.

Competition in Europe continued to be aggressive in microplates and the immunoassay lines edged up only slightly. The strong growth came from clinical applications of bacteriology lines, significantly with Vitek 2, and molecular biology products. Sales of industrial applications were up by 7.8%.

bioMérieux reported its Vidas line returned to growth, lifted by sales of the Vidas Brahms PCT and other medical assays.

In North America, gains were driven by the bacteriological and molecular biology lines. For industrial applications, the company credited a 14.4% growth to the strong start for Tempoand sustained growth in the Vitek 2 lines and the BacT/Alert sterility control reagents.

The FDA granted 510(k) clearance in the fourth quarter for the Vidas Brahms PCT, making bioMérieux first to market in the U.S. with an automated test for procalcitonin (PCT), a biomarker for severe sepsis and septic shock used to screen patients admitted to intensive care units.

Eroding the reporting of annual performance was a “currency effect” that cost bioMérieux €29 million ($43.5 million) and the €44 million ($66 million) impact of divesting its hemostasis business and discontinuing in North America microplate immunoassays operations.

The second half of 2007 saw a sustained business demand and bioMérieux said its installed base grew by 3,800 new instruments placed with customers, to 49,000 systems worldwide.

The company said it expects to sustain its current growth rate into 2008 and said that including new business development agreements it could reach an 8.5% increase.

The week previous bioMérieux reported a strategic agreement with Quidel (San Diego) to become the primary distributor outside the U.S. for QuickVue rapid diagnostic point-of-care tests. Japan and Scandinavia also were excluded from the distribution agreement.

The two companies said they also will co-develop new rapid tests in the area of infectious diseases by combining Quidel’s rapid test development capability and bioMérieux’s library of antibodies and antigens.

Quidel’s product line includes tests for the diagnosis of influenza, respiratory syncytial virus, fecal occult blood, Strep A, pregnancy, bacterial vaginosis, H. pylori and chlamydia.

bioMérieux has more tan 1,900 sales, marketing and service representatives in 150 countries worldwide.

In another development, Agence France Press (AFP) on Jan 22 reported Merck & Co. signed an agreement with bioMérieux to co-develop an immuonassay test for infectious disease that is promoted as a “theranostic” test by bioMérieux. No financial information about the agreement was reported.

Theranostic tests are a convergence of diagnostics with drug therapy where levels of measured analytes can predict a patient’s probable reaction or success with the therapy, allowing a more personalized drug therapy to be applied, and then measured again.

“Theranostic is a new business unit for us that we really believe in,” Stéphane Bancel, chief executive of bioMérieux, told AFP. He said he has formed a research and development team of a dozen people to focus on the Merck project.

In September, bioMérieux signed an agreement to develop a theranostic test for breast cancer with the French pharmaceutical firm Ipsen (Paris).

French hospital to get Elekta systems

Elekta (Stockholm, Sweden) reported that University Hospital Center de Poitiers (Poitiers, France) has selected the company as the main partner in what it termed “an ambitious program to improve radiation therapy treatment capacity in the Poitou-Charente region.”

Replacing equipment from a different vendor, the hospital recently signed a contract with Elekta to deliver three Elekta Synergy digital linear accelerator systems for intensity-modulated and image-guided radiation therapy (IMRT and IGRT).

The order is valued at close to 15 million.

IMRT and IGRT have during the last couple of years become standard for new deliveries of radiation therapy solutions and Elekta Synergy is being established as the reference system for what the company termed “this more precise and accurate method for radiating cancer tumors.”

“Radiation therapy is one of the most important weapons in the arsenal to fight cancer,” said Jean-Pierre Dewitte, CEO of Poitiers University Hospital. “Integrated 3-D imaging, which is what is needed for true image-guided treatment, will most certainly be one key factor for future improved outcomes.”

Dutch center adds Illumina products for study

Illumina (San Diego) reported that Erasmus Medical Center (Rotterdam, the Netherlands) has purchased Infinium HD Human610-Quad BeadChips for the analysis of 10,000 samples and a third scanner to support the Generation R Study.

Designed to identify early environmental and genetic causes of normal and abnormal growth, development and health from fetal life until young adulthood, the Generation R Study is a population-based prospective cohort study of almost 10,000 children and their parents. The study is funded by the medical center, the Dutch government and other industry partners.

“By purchasing another scanner and moving to Illumina’s four-sample BeadChip, we are gaining speed and efficiency that is otherwise not available to us. We hope that the Generation R Study unveils results that help us contribute to the development of strategies for optimizing health and healthcare for pregnant women and children,” said Professor Albert Hofman, chair of the Generation R Study Group.