Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu) announced today that it plans to launch gene amplification detector RD-100i, which extracts and amplifies genes in lymphatic tissues in order to detect lymph-node metastasis in approximately thirty minutes, as well as related reagents, in European Markets in April 2006, while boosting its activities for increased brand recognition and solution sales.
The RD-100i is the first commercial offering for clinical-use from the company's life science lines. As a new diagnostic technology application, the product has undergone clinical studies in Japan as well as in European and North American countries to date, and is now ready to debut in Europe’s markets ahead of the rest of the world. Upon the product's launch into the market, we will make greater efforts to well-prepare the product to be covered by insurance in Europe, and enhance its recognition at academic meetings and other occasions. We are also going into full swing in our solution sales activities in countries such as The Netherlands, Germany, and the United Kingdom, where clinical study is currently underway, so that we attract new institution customers and ensure wider recognition of the product’s utility as a testing technology.
For the time being, we plan to phase-in the target areas in Europe, with the aim of market launch in Japan and the United States in fiscal 2007.
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The advent of an aging society has brought with it an increase in patients of cancer and lifestyle diseases, giving rise to renewed interest in the healthy life expectancy and quality of life (QOL). In the United States and Europe, as well as in Japan, governments are shifting emphasis from treatment- to prevention-oriented healthcare policies, in an attempt to extend healthy life expectancy and control rising healthcare costs.
Anticipating that laboratory tests for early detection and prevention of recurrence will assume greater importance, we are focusing our R&D efforts on development in the life science field of tests that improve patients’ QOL, contribute to the detection and therefore indirect reduction of diseases around the world, and create new markets along with facilitating the standardization of testing routines. Particularly, we decided to direct our efforts towards cancer treatment, and apply technologies that analyze the functions of genes and proteins for the development of new testing technologies that will help achieve disease management for cancer patients. Currently, we are also committed to commercialization of the technologies by building infrastructures for clinical studies on testing technologies and support for scientific research, increasing awareness of them in the market, as well as other related activities in Japan, Europe, and the United States.
The key to treating breast cancer is to detect cancer cell metastasis both promptly and accurately. Using Sysmex’s proprietary "One Step Nucleic Acid Amplification” (OSNA), RD-100i and related reagents reduce the detection time to approximately thirty minutes, dramatically faster than the conventional method of anatomic pathology testing of the lymph-node sections. Detecting lymph-node metastasis during an operation of early breast cancer makes it possible to peroperatively resect any lymphatic tissue with metastasis, thus easing the patient burden from operations while reducing the risk of recurrence.
We have decided to pursue opportunities in the life science business, a new core business that will help us realize our goal of creating a healthy society. Accordingly, to make a full-fledged launch of the life science business possible, we will further accelerate the drive to create new markets.
[About breast cancer]
Worldwide, more than approximately 1.1 million cases of breast cancer are diagnosed in one year, with approximately 200 thousand in the United States, approximately 30 thousand in three European countries including Great Britain, Germany, and France and approximately 30 thousand in Japan. Each year, approximately 170 thousand breast cancer operations are performed in the United Sates, approximately 110 thousand in three European countries, and approximately 20 thousand in Japan (Company estimate). In Japan, the number of breast cancer patients is growing every year. In fact, breast cancer tops stomach cancer in becoming the most frequently occurring cancer in women.
[About Quality of Life]
Quality of Life (QOL) refers to the maintenance of human dignity and improved well-being. For this purpose, it is required to offer more patient-oriented treatment.
[About disease management for cancer patients]
Sysmex aims at “disease management,” a management system of introducing new tests to provide patients with the most appropriate treatment. While supplementing conventional pathology testing with our proprietary technologies, including rapid cancer lymph-node metastasis detection, recurrence prediction, which assesses the risk of cancer recurrence based on characteristics of the cancer, and detection of sensitivity to anticancer drugs, which determines the effect of anticancer drugs beforehand, we are expediting R&D and commercialization of testing technologies that contribute to diagnosis, treatment, and risk prevention of cancer.
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Gene Amplification Detector RD-100i |
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Gene Amplification Reagent LYNORHAG |
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Gene Amplification Reagent LYNOAMP BC |
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Gene Amplification Detector |
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Reagents |

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