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RUSNANO and France's Magnisense to Produce Diagnostic Systems in Russia

RUSNANO and Magnisense today announced that they have finalized details for investment in Magnisense SE, a French developer of the next generation of in vitro bioassays for diagnostic testing in healthcare, veterinary medicine, food safety, and environmental protection. RUSNANO will invest up to €28.5 million over a three-year period in the joint project whose total cost is put at €44.3 million. The remaining co-investment will come from Magnisense's existing and new shareholders.

The new project will manufacture in Russia an advanced diagnostic system based on Magnisense's proprietary technology MIAtek®—a magnetic immunoassay in which nanosized magnetic beads are attached to an antibody that selectively binds target molecules, micro-organisms, or other antibodies in test media. The technology combines the accuracy of laboratory testing with the simplicity and compactness of rapid-test methods to provide rapid and reliable diagnostics for cardiovascular emergencies, HIV and other sexually transmitting diseases, beta-hCG levels, microbiology conditions, and vaccination control to name a few. The magnetic signal is free of interference from environmental factors, permitting more sensitive and reproducible detection than is possible with traditional markers employed in enzymatic and fluorescent technologies.

Magnisense will establish a Russian subsidiary to produce two product lines:

MIAstrip®: point-of-care testing strips that identify a target by detecting known markers for a number of conditions—cardiac arrest, bacterial infections including tetanus, viral infections such as avian flu, and parasitic and fungal infections;
MIAflo®: disposable cartridges that detect and quantify such targets as bacterial contaminants in food (e.g., Listeria and Salmonella) or water (e.g., Legionella).

Magnisense's Russian manufacturing facility is expected to open in 2015 with production capacity of 3.5 million test media. The media will be sold domestically and exported, primarily to Europe, the US, and Japan.

In the future, Magnisense intends to increase production in Russia and to focus on the professional segment of the decentralized diagnostic testing market generally known as point-of-care (POC). It will expand into the CIS, Europe, the US, Japan, and China. POC diagnostics—tests performed in medical environments, the workplace, and at home—have become the driving force in the world's healthcare market. According to Kalorama Information, a market research company specializing in healthcare and related areas, decentralized diagnostics is the fastest growing segment in healthcare. And the professional POC market, already $5.2 billion in 2009, is estimated to be growing at an annual rate of 6 percent with its rate of growth accelerating.

"Transferring this technology to Russia will involve establishing a production facility and an R&D center," said RUSNANO Managing Director Olga Shpichko. "The project will contribute to the array of new diagnostic and treatment methods being developed in the country with RUSNANO's help."

Advantages of MIAtek® technology

Higher quality. The technology is based on magnetic bead markers instead of fluorescent labels or changes in optical density, as is common in enzymatic and fluorescent technologies. This makes the readings independent of transparency or color of the sample and enables direct analysis of blood and other non-homogeneous biological samples. Virtually every magnetic label is counted, providing the highest sensitivity and the most reliable reproduction of results. In comparison with immunoabsorbent assay methods, sensitivity and accuracy are several times greater for such conditions as cardiac arrest.

Easier, faster, simpler. The ability of Magnisense technology to use non-homogeneous test samples such as whole blood reduces time in sample preparation, meaning that results are obtained more quickly, often in as little as 15 to 20 minutes. Moreover, Magnisense testing does not require special medical training or experience. It can be done by a nurse or by the patient himself. The test can be done and its results ready during the patient's office visit and immediately discussed with the doctor. Ease, speed, and simplicity significantly decrease the cost of the procedure and save time for doctors and patients.

Lower cost, more compact. The reader is portable, compact, and low cost. It does not require space or capital expense for a special environment. The physician in solo or group practice could purchase a reader and locate it in his/her office lab.

Wider application. In addition to medical applications, Magnisense is developing tests to monitor the quality of food and air. The company's proprietary technology provides accurate measures of biological targets, singularly or in combination, even in large-volume samples.

Magnisense's reader counts biomarkers

Magnisense's reader counts biomarkers—viruses, bacteria, hormones, enzymes, DNA strands—labeled with superparamagnetic particles in the MIAstrip or MIAflo carrier (grey tube on the right). The results are displayed on a smartphone for analysis in place or wireless transfer.

In the MIAtek® technology, the biomarker being analyzed is labeled with superparamagnetic particles instead of fluorescent and other types of labels used in traditional methods. Magnisense's reader counts magnetic particles with high accuracy without time- and cost-consuming sample processing.

MIAtek technology has the potential to become a leader in the diagnostics segment and to take a major share of the market for in vitro diagnostics worldwide. It will replace technologies used in laboratories today that were developed in the later of the twentieth century. These tests take a long time from sample to result, are costly, and will not comply with future requirements from regulatory authorities.

MIAtek® may also play an important social role. With an aging population, better treatment of chronic illnesses, and governments that are more conscious of the need to reduce healthcare costs, healthcare and related fields will become more and more decentralized. Magnisense has designed its technology—flexible, compact, easy to use, and low cost—to work compatibly with our changing world.

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