Beckman Coulter Announces FDA Clearance Of UniCel(R) DxH 800

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Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 27 Dec 2008 - 0:00 PDT

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Beckman Coulter, Inc. (NYSE: BEC), a leading developer, manufacturer, and marketer of products that simplify and automate complex biomedical testing, ushers in a new era of cellular analysis with the release of the UniCel(R) DxH 800 Coulter(R) Cellular Analysis System.

Capturing 29 individual measurements per cell analyzed, the system provides improved sensitivity and specificity, which means more reliable assessment of abnormal cell populations. Laboratories equipped with the system will be able to respond more quickly and accurately to physician demands, improving patient health and reducing the cost of care.

"The UniCel DxH 800 will transform the hematology lab with unparalleled quality of results, innovative efficiency and revolutionary scalability, reinforcing Beckman Coulter's place at the forefront of cellular analysis," said Cynthia Collins, group vice president of Cellular Analysis at Beckman Coulter.

The system's all new physical design - demonstrated by more than 40 new and pending patents - minimizes moving parts, increasing instrument reliability and technologist efficiency. The modular and scalable design makes the DxH 800 the ultimate solution for a variety of market segments. Multiple systems can be connected easily into a work cell to meet the volume needs of a broad range of labs from mid- to very high-volumes. A unique magnetic Specimen Transport Module (STM) transports cassettes between connected instruments with no track required.

Future platform enhancements include an automated Slide Maker/Stainer, featuring the same patented STM technology for transporting samples. A single SMS unit will support multiple DxH 800 systems, automatically balancing the workload for connected systems and making slides based on user-defined Decision Rules, without operator intervention.

Another significant future enhancement will be the incorporation of flow cytometry technology which will further extend the DxH 800 systems' ability to yield an unparalleled breadth of information. This new capability will decrease the number of manual reviews required today - greatly enhancing the efficiency of the laboratory, while extending the cellular analysis menu of tomorrow. Future applications may include monitoring provisions for Sepsis, Cancer, HIV, Diabetes and other high value disease states.

The UniCel DxH 800 system advances the technology that made Coulter systems the worldwide market leader and will change how labs manage their cellular analysis process.

About Beckman Coulter

Beckman Coulter, Inc., based in Orange County, California, develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 200,000 Beckman Coulter systems operate in laboratories around the world, supplying critical information for improving patient health and reducing the cost of care. Recurring revenue, consisting of supplies, test kits and operating-type lease payments, represents approximately 78 percent of the company's 2007 annual revenue of $2.76 billion. For more information, visit http://www.beckmancoulter.com.

Beckman Coulter, Inc.
http://www.beckmancoulter.com

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