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Mitsubishi Chemical Medience Corporation Receives 510(k) Clearance for PATHFAST® cTnI-II (cardiac Troponin I) Test in U.S.
Date:6/13/2011

ecimen preparation, and can be used with either plasma or serum. The system has a 17-minute turn around time, a feature that can significantly reduce testing time, which can be a key consideration in a clinical laboratory or point-of-care (POC) setting.  

Mitsubishi Chemical Medience and Mitsubishi Chemical Europe have sold more than 1,000 units of the PATHFAST system in Asia, Europe, and Latin America. The PATHFAST cTnI-II test is considered "guideline acceptable" by virtue of its minimal imprecision, as measured by a coefficient of variance (CV) of less than or equal to 10% at the 99th percentile.(3) By generating precise, accurate, and rapid results, the PATHFAST cTnI-II test is expected to enhance patient safety by streamlining coordination between emergency POC and central laboratories. It may be particularly useful in the emergency room (ER) setting, as well as in satellite laboratories, physician laboratories, and central laboratories.

About Mitsubishi Chemical Medience Corporation

Mitsubishi Chemical Medience Corporation is a member of the Mitsubishi Chemical Holdings Corporation Group, which is headquartered in Tokyo, Japan. Mitsubishi Chemical Medience is the first company in Japan to establish a business style that combines clinical and diagnostic laboratory testing services with in vitro diagnostics (IVD) and pharmaceutical development support. One of Mitsubishi Chemical Medience's primary business areas is their IVD business, which includes the development, sale, export, and import of in vitro diagnostic reagents and instruments. Mitsubishi Chemical Medience's globally accepted PATHFAST system, a rapid point-of-care immunochemistry analyzer, has been exported to more than 40 countries. Throughout almost five decades of IVD business, customers in various chemical and diagnostic industry segments have come to trust and rely on Mitsubishi Chemical Medience's competence and strength, as represented by the superior q
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