Roche presented data demonstrating the use of GCP-compliant quantitative MRM mass spectrometry platform in clinical trials
| MONTREAL, April 25, 2019 /PRNewswire/ - Caprion Biosciences Inc. is pleased to announce the completion of a collaborative study using mass spectrometry to quantify biomarkers in clinical samples. The results presented by Dr. Axel Ducret (F. Hoffmann-La Roche Ltd.) at the recent MSACL conference (Mass Spectrometry Applications to the Clinical Lab) in Palm Springs further support the use of targeted MRM mass spectrometry for the quantification of biomarkers in large sets of clinical samples, within a regulatory environment.
Caprion leveraged its bioanalytical and regulatory expertise to develop an assay in a GCP environment that meets the requirements of clinical biomarker programs. Using CPTAC peptides and guidelines, the assay showed robustness, reproducibility and allowed for the simultaneous quantification of twelve proteins in formalin-fixed, paraffin-embedded (FFPE) samples. “This innovative study highlighted the technology’s robustness for optimal biomarker strategy in clinical studies,” said Lorella Di Donato, Senior Vice President and Chief Operating Officer. “Understanding the applicability of MRM quantitation versus a discovery approach in a GCP environment is fundamental. From the on-set, we focus on designing the appropriate assay from a scientific, technical and regulatory perspective. We ensure data validity by comprehensively characterizing assay parameters such as specificity, interference, carry over and matrix effects. Our experience showed that applying strong analytical interpretation is key for the optimal selection of surrogate peptides and therefore, assay performance”. “Our contribution further highlights Caprion’s position as a leader in the development of complex biomarker assays,” said Martin LeBlanc, President and CEO. “Caprion’s extensive expertise in the development and validation of complex mass spectrometry bioanalytical assays for multiplexed protein quantitation differentiates us and provides our partners with the confidence to move forward with their clinical programs.” About Caprion Biosciences, Inc. For more information, please visit http://www.caprion.com/
SOURCE Caprion Biosciences |
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