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Specificity and Quantification in Chimerism Analysis Deliberate assortment of genetic markers is required, tailored product-design is mandatory Biotype Diagnostic

offers a commercially available multiparameter ana lysis for specific chimerism analysis. Dresden, Germany, June 26, 2012 -- Chimerism analysis is compulsory to examine t he therapeutic success of stem cell transplantation and to estimate the potentia l risk to suffer a relapse. Through this analysis, relative ratio of donor - and recipient - derived stem cells is quantitatively displayed and explicitly revea ls the status of transplant engraftment. For this reason a deliberate and specif ic choice of the applied diagnostics is essential. Biotype Diagnostic developed a commercially available multiparameter analysis for specific chimerism analysis . This molecular application was validated by monitoring chimerism status of mor e than 200 related donor-recipient-pairs; a unique feature of that assays. Hence , this application meets all diagnostic requirements for a sensitive and informa tive chimerism analysis. In general the predictive value of a multiparameter analysis relies on the sensi tivity and the specificity of deployed components. These components also account for robustness and thus reproducibility of generated results. Therefore, the mi nute choice and accurate combination of parameters utilised is of vital interest if a reliable diagnostic should be established. The idea to compensate weakness es of single parameters by inserting multiple other parameters is likewise misle ading then the consumption that redundancy amongst single parameters could accou nt for improved analytical value. A sound application to monitor chimerism requi res strong components that generate as little background as possible and allow a clear, unambiguous differentiation of donor - and recipient - derived stem cell s. Establishing such a diagnostic multiparameter analysis therefore asks for ext ensive bio-medical know-how and long lasting empirical value. Moreover, specific validation on relevant clinical samples is mandatory in order to test for speci ficity and significance. Since most multiparameter analyses, applied for chimerism monitoring, have not s pecifically been tested for this medical area, this accurate test-system will be of high interest for clinical experts. Biotype is filling the market niche that has last for a long time by providing an expert solution for reliable and effec tive chimerism testing. Mentype Chimera addresses 12 highly polymorphic genetic sequences that show balanced distribution within the population and generate only nominal background signal. Contact: Dr. Sophia Mersmann Biotype Diagnostic GmbH Moritzburger Weg 67 Dresden, Germany +49 351 8838 432 s.mersmann@biotype.de http://www.biotype.de

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