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Sysmex Launches Clinical Flow Cytometry System in Japan
- Realizing Higher Efficiency and Standardization of Flow Cytometry (FCM) Testing -
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) will launch its Clinical Flow Cytometry1 System Flow Cytometer XF-1600, Sample Preparation System PS-10, antibody reagents, and other related products in Japan in May 2023, following the launch in North America, Europe, and Asia Pacific regions. Sysmex’s flow cytometry portfolio makes it possible, in combination with monoclonal antibody2 reagents, for laboratories to automate the entire process of flow cytometry testing from sample preparation to the reporting of measurement results of clinical FCM testing used for diagnosis and detailed analysis of hematological diseases such as leukemia and malignant lymphoma. This contributes to higher efficiency and testing standardization.
Flow cytometry is a technology in which microscopic particles are optically analyzed as they pass through channels. This basic principle is used in Sysmex’s hematology and sediment urinalysis analyzers. Flow cytometers, measuring devices that use FCM technology, are utilized by pharmaceutical manufacturers and universities to research cancers and regenerative medicine, as well as in clinical testing and other domains. They are also used in various industrial applications, such as quality control for food and beverages. In the clinical domain, high accuracy and prompt result delivery are required for these measurements, because FCM testing is performed for a detailed examination of cells after blood cell counting (hematology) tests. These processes typically involve complicated and time-consuming manual operations, such as dispensing samples and reagents, as well as agitation and incubation. The significant burden this places on highly skilled clinical laboratory technologists in their daily work is an issue in laboratory settings.
In 2013, Sysmex acquired Partec (now Sysmex Partec), a pioneer in FCM technology that has accumulated know-how in this field for many years, and has strived to establish a clinical flow cytometry system that can automate the FCM testing process by combining Sysmex’s cell counting technology with Partec’s.
Sysmex will launch its Clinical Flow Cytometry System, which combines the Flow Cytometer XF-1600, Sample Preparation System PS-10, antibody reagents, and other related products in Japan in May 2023, following the launch in the North American, European, and Asia Pacific markets. The System makes it possible for laboratories to automate the entire testing process, from sample preparation to the reporting of measurement results in clinical FCM testing. This achieves higher efficiency and standardization of testing and reduces the burden placed on clinical technologists, allowing them to focus on the more technically demanding analysis of testing results.
Going forward, Sysmex will continue to further expand markets to provide its Clinical Flow Cytometry System, aiming to maximize a synergy with the hematology field.
Product Overview
Product Photo
| Generic name: | Flow Cytometer | ||||
| Product name: | Flow Cytometer XF-1600 (Medical Device Marketing Notification No.: 28B1X10014000009) |
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| Marketing Authorization Holder: |
Sysmex Corporation
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| Target market: | Japan | ||||
| Launch: | May 2023 | ||||
| Generic name: | Sample Preparation System | ||||
| Product name: | Sample Preparation System PS-10 (Medical Device Marketing Notification No.: 28B1X10014000003) |
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| Marketing Authorization Holder: | Sysmex Corporation | ||||
| Target market: | Japan | ||||
| Launch: | May 2023 | ||||
Product Photo
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| Clinical Flow Cytometry System | Antibody reagents (for research) |
Reference
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August 6, 2019 news release: “Sysmex Launches its Sample Preparation System PS-10 in North America, a New Product to Make Clinical Flow Cytometry Testing More Efficient”
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June 17, 2020 news release: “Sysmex Launches Flow Cytometer XF-1600 in North America |
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Terminology
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Flow cytometry (FCM):
Method involving the flow dispersion of minute particles and the use of lasers to optically analyze minute flows. Used primarily to observe individual cells.
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| 2 |
Monoclonal antibody:
A monoclonal antibody is a molecule obtained from a clone derived from a single antibody production cell. Common polyclonal antibodies are prepared from the blood serum of animals with antigen immunity, so include a mixture of various types of antibody molecules, but a monoclonal antibody has only one type of molecule.
A flow cytometer analyzes human blood by combining a human CD marker with a monoclonal antibody to analyze a specific cell population that contributes to immunity, allowing the human immune state to be determined.
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Sysmex’s Materiality
| Sysmex has identified the “Creating new value for a healthy society” as one of the issues that we prioritize (materiality), and we are working toward the resolution of medical issues through innovation. Through various collaborations, we aim to offer new value to make each individual's healthcare journey better and grow as an essential presence in society. | |
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- The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.