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医学捌号楼·医疗资讯·首个便携式内毒素(endotoxin)测试系统“Endosafe-PTS(TM)”获得FDA的批准
首个便携式内毒素(endotoxin)测试系统“Endosafe-PTS(TM)”获得FDA的批准
www.med8th.com  |  2006年7月20日

(BW)(MA-CHARLES-RIVER-LABS)(CRL) Charles River实验室获得FDA的批准,进行首个便携式内毒素测试系统“Endosafe-PTS(TM)”的销售和营销;具有突破性意义的一键通技术革命化了内毒素检测

美国商业新闻2006年7月18日美国马萨诸塞州威尔明顿消息——

Charles River 实验室国际有限公司(Charles River Laboratories International, Inc.)(纽约证券交易所:CRL)已经获得美国食品及药物管理局(FDA)的批准,美国食品及药物管理局允许其销售和营销首个便携式内毒素(endotoxin)测试系统“Endosafe-PTS(TM)”。获得专利的Endosafe-PTS(TM)可用于检测药品、医疗设备、生物制品及其他独特应用中(包括国家航空和宇航局空间飞行器航行(NASA spacecraft missions))中所含有的内毒素污染物。PTS是一项革命化的技术,其:

——是一个便携的手持系统,可被用在使用点的检测中

——在15分钟内就可提供定量结果,而当前的其他方法需要花费45分钟或几天的时间

——仅需要稍稍进行培训就可学会使用——仅需插入PTS滤筒,添加样品及读取定量结果

通过迅速、方便的提供内毒素污染物的检测结果,Endosafe-PTS(TM)系统可加速新药品的发现和开发,因此,节省了药品公司、医学专业人士和科学家在生产流程中的时间和费用。

PTS系统在现实世界中可应用于以下领域,包括:

——医疗设备&可注射药品

——透析临床

——核医学

——医院

——干细胞研究

——行星保护

PTS采用一次性滤筒(该滤筒中事先装有试剂)以及一个便携的手持阅读器来提供定量的内毒素值。鉴于其便携性,PTS可在样品收集点处进行检测。此外,简单的一键通操作仅需进行较少的技术培训就可学会使用,数据可以被存储在PTS中,下载到计算机和/或打印出来。

最近,国家航空和宇航局使用Endosafe-PTS(TM)来监测构造火星探测漫游者(Mars Exploration Rovers)“勇气号”和“机遇号”过程中微生物污染物所处的环境。计划在国际太空站中操作PTS部件,以对微生物污染物所处的环境进行监测。PTS未来的应用可能包括检测火星上微生物生命的迹象。

关于Charles River实验室

Charles River实验室位于美国马萨诸塞州威尔明顿,是一家解决方案的全球提供商,其解决方案增强了药品的发现和开发过程。我们处于技术前沿的产品和服务致力于使我们的客户把其药品更快、更高效的投放到市场中。受我们精确的、最先进的程序和获得认可的数据收集、分析和报告能力的支持,我们的产品和服务分成三个种类,涵盖药品开发过程中的每一个环节:研究模式和服务、临床前服务以及临床服务。Charles River的客户群包括所有主要的制药公司和许多生物技术公司、政府机构和先进的医院及众多学术机构。Charles River的8500位员工为50多个国家的客户提供服务。欲知关于Charles River的更多信息,请访问我们的网站:www.criver.com 。

前瞻性声明警示。本新闻稿中包括1995年《私人证券诉讼改革法案》中所界定的前瞻性声明。这些前瞻性声明可能是使用了诸如“预期”、“认为”、“希望”、“将要”、“可能”、“估计”、“计划”、“前景”和“项目”以及其他类似的对未来事件或趋势或非有关历史事件声明表述所用的词语。本注示中的这些声明涉及Charles River对PTS系统的市场及潜在应用性的预期。Charles River不能担保PTS的市场一定能按预期那样获得开发,或PTS系统的特殊应用一定是可行的。该前瞻性声明是基于Charles River当前的期望和信念,包含了许多风险和不确定因素。这些风险和不确定因素可能会导致实际结果与这些表述或前瞻性声明所暗示的结果存在本质的区别,公司在2006年3月14日归档的Charles River年报表10-K以及提交给美国证券交易委员会的其他文件中对这些风险、不确定因素和其他事件都进行了详尽的描述。除非法律要求,否则Charles River不承担更新此发布中信息的责任,并明确表示不承担更新的义务。

多媒体访问:

http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5189561

联系方式:Charles River实验室国际有限公司 全球通信部总监 Elizabeth Ferber, 978-658-6000 传真: 978-658-7841 corpcomm@crl.com

(BW)(MA-CHARLES-RIVER-LABS)(CRL) Charles River Laboratories Receives FDA Approval for Sale and Marketing of First Portable Endotoxin Test System, the Endosafe-PTS(TM); Breakthrough One-Button Technology Revolutionizes Endotoxin Detection

WILMINGTON, Mass.--(BUSINESS WIRE)--July 18, 2006—

Charles River Laboratories International, Inc. (NYSE:CRL) has received FDA approval that allows for the sale and marketing of the first portable endotoxin test system, the Endosafe-PTS(TM). The patented Endosafe-PTS(TM) is used to detect endotoxin contaminants in drugs, medical devices, biological products and other unique applications including NASA spacecraft missions. The PTS is a revolutionary technology that:

-- is a portable handheld system that can be used for point of use testing

-- provides quantitative results in 15 minutes rather than current methods which take from 45 minutes to several days

-- requires minimal technical training - just insert the PTS cartridge, add sample and read quantitative results

The Endosafe-PTS(TM) system can accelerate the discovery and development of new drugs by offering quick and easy endotoxin contamination results, thereby saving pharmaceutical companies, medical professionals and scientists both time and money in the manufacturing process.

Real world applications for the PTS system include:

-- Medical devices & injectable drugs

-- Dialysis clinics

-- Nuclear medicine

-- Hospitals

-- Stem cell research

-- Planetary protection

The PTS utilizes disposable cartridges that are pre-loaded with reagents and a portable, handheld reader to provide quantitative endotoxin amounts. Because of its portability, the PTS allows for testing to be performed at the point of sample collection. In addition, the simple one-button operation requires minimal technical training and the data can be stored in the PTS, downloaded to a computer and/or printed.

NASA recently used the Endosafe-PTS(TM) to monitor the environment for microbial contamination during the construction of the Mars exploration rovers "Spirit" and "Opportunity". PTS units are scheduled to be flown to the International Space Station to perform environmental monitoring for microbial contamination. Future applications of PTS may include detecting signs of microbial life on Mars.

About Charles River Laboratories

Charles River Laboratories, based in Wilmington, Massachusetts, U.S., is a global provider of solutions that advance the drug discovery and development process. Our leading-edge products and services are designed to enable our clients to bring drugs to market faster and more efficiently. Backed by our rigorous, best-in-class procedures and our proven data collection, analysis and reporting capabilities, our products and services are organized into three categories spanning every step of the drug development pipeline: Research Models and Services, Preclinical Services, and Clinical Services. Charles River's customer base includes all of the major pharmaceutical companies and many biotechnology companies, government agencies and leading hospitals and academic institutions. Charles River's 8,500 employees serve clients in more than 50 countries. For more information on Charles River, visit our website at www.criver.com.

Caution Concerning Forward-Looking Statements. This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "will," "may," "estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements include the statements in this notice regarding Charles River's expectation regarding the markets for and potential applications of the PTS systems. Charles River cannot guarantee that the markets for PTS will develop as expected, or that specific applications of the PTS system will be viable. Forward-looking statements are based on Charles River's current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River's Annual Report on Form 10-K as filed on March 14, 2006, as well as other filings we make with the Securities and Exchange Commission. Charles River assumes no obligation and expressly disclaims any duty to update information contained in this release except as required by law.

MULTIMEDIA AVAILABLE:

http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5189561

Charles River Laboratories International, Inc. Director, Global Communications Elizabeth Ferber, 978-658-6000 F: 978-658-7841 corpcomm@crl.com

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