Walter Koch,
Vice President,
Roche Molecular Systems
Walter H. Koch, Ph.D., has been in his current role of Vice President and Head of Global Research for Roche Molecular Systems since 2005. Dr. Koch is responsible for all RMD research and early development activities, including research efforts associated with biomarker discovery and validation, the development of new technologies with diagnostics potential such as next generation sequencing, and continuing improvements in the performance of existing real time PCR products and technologies. He joined RMS in 1998 as a Research Leader to evaluate the feasibility of developing microarray-based pharmacogenetic assays for clinical diagnostic use, resulting in the launch of the AmpliChip® CYP450 assay. From 2001-2004 he served as the Senior Director of the Pharmacogenetics Department, leading six scientific teams. In this role, he was responsible for development of genetic and pharmacogenomic assays using Affymetrix oligonucleotide microarray, linear array, and real-time PCR technologies and platforms. Prior to joining Roche he held several positions within the US FDA, including Acting Lab Chief of Immunochemistry and Research Biologist in the CBER’s Division of Transfusion Transmitted Disease, and Research Biologist positions in the Division of Molecular Biological Research & Evaluation, and the Division of Toxicology within CFSAN. He received a B.S. in Chemistry from Memphis State University, a Ph.D. in Toxicology and Pharmacology from the University of Tennessee Health Science Center, and Postdoctoral training at the Johns Hopkins University School of Public Health.
Blood-based Detection of EGFR Mutations is Predictive of Survival Outcomes in Patients Treated with First-line Erlotinib Intercalated with Chemotherapy
Tarceva is approved for first line use in NSCLC patents whose tumors have been shown to have activating mutations in the EGFR receptor, usually assessed with FFPE samples by PCR tests like the cobas® EGFR Mutation Test. The ability to accurately and sensitively detect EGFR mutations from blood (so-called liquid biopsy) could provide an alternative to biopsy tissue for initial therapy selection. Moreover, quantitative assessment of dynamic changes of EGFR mutations in plasma could be an indicator of initial treatment response, disease progression, and development of resistance mutations (eg T790M). Retrospective analysis of 238 matched tissue and blood samples from the FASTACT2 clinical study using the cobas® EGFR mutation test and the cobas® EGFR blood test (in Development) has shown high concordance of EGFR mutational status between tissue and blood, with comparable prediction of PFS and OS. Further, a drop in plasma EGFR mutations to undetectable at treatment cycle 3 was associated with significantly longer OS compared to any detectable plasma EGFR mutations. In a separate collaboration, measurement of plasma EGFR mutation levels every 4 weeks during erlotinib treatment provided evidence for initial treatment response, as well as disease progression and the emergence of the T790M resistance mutation as early as 11 months before clinical disease progression. These results suggest the use of cell free DNA in plasma to assess EGFR mutation status may be a feasible alternative in those patients for whom a tumor biopsy cannot be obtained. Additionally, dynamic changes in plasma EGFR mutation levels may be predictive of clinical outcome, including disease progression and identification of specific resistance mechanisms.
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