# New Pathology ## Site description Independent consulting in molecular pathology, precision oncology, digital pathology, laboratory workflow design, molecular diagnostics and AI-assisted pathology workflows. Canonical website: https://www.newpathology.de/ Contact: https://www.newpathology.de/#contact --- # Consulting Services Independent consulting in molecular pathology, oncology biomarkers, genomic diagnostics, reimbursement strategy, and market access. Consulting support for pharmaceutical and biotechnology companies, diagnostics developers, investors, market research organizations, and selected laboratory or clinical strategy projects. The focus is on molecular pathology consulting, precision oncology consulting, oncology biomarker consulting, and genomic diagnostics consulting. Consulting services and expert interviews are provided to pharmaceutical companies, diagnostics developers, investors and market research organizations seeking insight into molecular diagnostics and precision oncology. This website describes consulting and advisory work for professional stakeholders. It does not offer public patient diagnostics. ## Audience - pharmaceutical and biotechnology companies - diagnostics developers - investors - market research organizations - selected laboratory or clinical strategy projects Contact: [Contact](https://www.newpathology.de/#contact) --- # About New Pathology and Lukas Heukamp Dr. Lukas Heukamp is a board-certified pathologist with a focus on molecular pathology and precision oncology. His work spans translational oncology, biomarkers, and genomic diagnostics, with an emphasis on the implementation of precision medicine approaches in real-world clinical practice. He has been involved in the evaluation and introduction of molecular diagnostics in oncology, including next-generation sequencing assays, liquid biopsy, and minimal residual disease concepts. His experience includes peer-reviewed publications in molecular pathology and translational oncology and collaboration with clinical, laboratory, and industry partners. His work also includes the design and implementation of digital pathology, laboratory software, automation, and AI-assisted diagnostic workflows, particularly where medical, molecular, and technical requirements intersect. ## Languages Consulting projects, advisory work, and expert interviews can be conducted in English, German, and Dutch. More: [Contact](https://www.newpathology.de/#contact) --- # Expertise Advisory work focuses on the design, implementation, and evaluation of molecular pathology and precision oncology diagnostics across research, clinical development, and routine care. Engagements typically combine molecular pathology consulting, precision oncology consulting, genomic diagnostics consulting, and reimbursement-focused perspectives. This also includes digital pathology and laboratory workflow consulting, including software architecture, automation and AI-assisted diagnostic workflows. An overview of selected expert topics in molecular pathology, precision oncology, reimbursement, and market access is available on the [expert topics in molecular pathology and precision oncology](https://www.newpathology.de/expert-topics) page. ### Molecular diagnostics and laboratory strategy - Oncology biomarker strategy from discovery to clinical implementation. - Laboratory strategy in molecular diagnostics, including assay selection and platform considerations. - Clinical implementation of advanced diagnostics in pathology workflows and precision oncology programs. - Advisory support for market research and expert network interviews on molecular pathology and genomic profiling. - Digital transformation of pathology laboratories, including workflow automation, software-supported diagnostics, AI integration, and the technical implementation of new diagnostic processes. ### Precision oncology and biomarker programs - Study-aligned biomarker concepts for precision oncology trials and translational oncology projects. - Integration of molecular pathology readouts into clinical decision pathways and tumor board processes. - Evaluation of diagnostic pathways, oncology biomarker consulting for launch preparation, and market readiness. - Independent review of evidence packages for genomic diagnostics, including analytical performance, clinical validity, and clinical utility. ### Digital pathology, software and AI-enabled workflows - Digital pathology strategy, including workflow design, system integration, and implementation in diagnostic laboratories. - Design and evaluation of software-supported pathology workflows, including laboratory automation, structured reporting, and integration with LIMS (laboratory information management system) and clinical systems. - Advisory support for AI and large-language-model applications in pathology, including transcription, report generation, information retrieval, and clinical workflow integration. - Prototyping and development of software solutions for pathology and molecular diagnostics as part of consulting and implementation projects. - Evaluation of IT architectures, local and cloud-based AI infrastructure, data flows, interoperability, and practical deployment requirements in pathology laboratories. --- # Molecular Pathology Molecular pathology consulting and laboratory strategy for oncology biomarker programs, genomic profiling, and clinical implementation. ## Molecular diagnostics and laboratory strategy - Oncology biomarker strategy from discovery to clinical implementation. - Laboratory strategy in molecular diagnostics, including assay selection and platform considerations. - Clinical implementation of advanced diagnostics in pathology workflows and precision oncology programs. - Advisory support for market research and expert network interviews on molecular pathology and genomic profiling. - Digital transformation of pathology laboratories, including workflow automation, software-supported diagnostics, AI integration, and the technical implementation of new diagnostic processes. ## Molecular Pathology & Precision Oncology - Molecular pathology consulting for oncology programs - Precision oncology consulting and tumor board workflows - Design of integrated pathology workflows for genomic profiling - Interpretation of complex genomic reports in solid tumors - Integration of molecular results into clinical decision pathways Related HTML: [Expertise](https://www.newpathology.de/#expertise) · [Expert topics](https://www.newpathology.de/expert-topics) --- # Precision Oncology Precision oncology consulting covering biomarker programs, tumor board workflows, and evidence review for genomic diagnostics. ## Precision oncology and biomarker programs - Study-aligned biomarker concepts for precision oncology trials and translational oncology projects. - Integration of molecular pathology readouts into clinical decision pathways and tumor board processes. - Evaluation of diagnostic pathways, oncology biomarker consulting for launch preparation, and market readiness. - Independent review of evidence packages for genomic diagnostics, including analytical performance, clinical validity, and clinical utility. Related HTML: [Expertise](https://www.newpathology.de/#expertise) --- # Liquid Biopsy and MRD Experience spans tissue-based and blood-based oncology biomarker assays, including DNA, RNA, and protein-level technologies. This includes next-generation sequencing oncology, immunohistochemistry biomarkers, and liquid biopsy diagnostics across solid tumors. ## Genomic technologies (liquid biopsy and MRD) - Liquid biopsy diagnostics and ctDNA (circulating tumor DNA) testing strategies, from feasibility to routine clinical adoption. - Minimal residual disease (MRD (measurable/minimal residual disease)) analysis in solid tumors, including the design and interpretation of tumor-informed MRD (measurable/minimal residual disease) assays and longitudinal monitoring concepts. ## Liquid Biopsy & MRD - Liquid biopsy diagnostics and ctDNA (circulating tumor DNA) testing strategies - Analytical and clinical aspects of ctDNA (circulating tumor DNA) assays - Minimal residual disease (MRD (measurable/minimal residual disease)) analysis in solid tumors and tumor-informed MRD (measurable/minimal residual disease) assays - Use of MRD (measurable/minimal residual disease) readouts in clinical trials and routine care - Positioning of liquid biopsy in existing pathology workflows Related HTML: [Biomarkers & Technologies](https://www.newpathology.de/#biomarkers) --- # Digital Pathology and AI Digital pathology and laboratory workflow consulting, including software architecture, automation and AI-assisted diagnostic workflows. ## Digital pathology, software and AI-enabled workflows - Digital pathology strategy, including workflow design, system integration, and implementation in diagnostic laboratories. - Design and evaluation of software-supported pathology workflows, including laboratory automation, structured reporting, and integration with LIMS (laboratory information management system) and clinical systems. - Advisory support for AI and large-language-model applications in pathology, including transcription, report generation, information retrieval, and clinical workflow integration. - Prototyping and development of software solutions for pathology and molecular diagnostics as part of consulting and implementation projects. - Evaluation of IT architectures, local and cloud-based AI infrastructure, data flows, interoperability, and practical deployment requirements in pathology laboratories. ## Digital Pathology, Software & AI - Digital pathology strategy and implementation in diagnostic laboratories - Software-supported pathology workflows, laboratory automation, and structured reporting - Integration with LIMS (laboratory information management system) and clinical systems - AI and large-language-model applications in pathology (transcription, report generation, retrieval) - Prototyping and development of software solutions for pathology and molecular diagnostics - IT architectures, local and cloud-based AI infrastructure, and interoperability - Practical deployment requirements for AI-enabled workflows in pathology laboratories Related HTML: [Expertise](https://www.newpathology.de/#expertise) · [Expert topics](https://www.newpathology.de/expert-topics) --- # Selected Expert Topics in Molecular Pathology and Precision Oncology This page lists selected topics that are frequently addressed in consulting projects, expert interviews, and discovery discussions. The emphasis is on molecular pathology, precision oncology, biomarkers, digital pathology and AI-enabled workflows, reimbursement, and market access for oncology diagnostics in Germany and Europe. ## Selected keywords and consulting topics - molecular pathology consulting - oncology biomarker strategy - liquid biopsy diagnostics - minimal residual disease (MRD (measurable/minimal residual disease)) testing - ctDNA (circulating tumor DNA) monitoring - tumor mutational burden (TMB (tumor mutational burden)) - homologous recombination deficiency (HRD (homologous recombination deficiency)) - microsatellite instability (MSI) - complex biomarker analysis - ESR1 mutations - PD-L1 testing - HER2 diagnostics - NGS (next-generation sequencing) panel design - hybrid capture NGS (next-generation sequencing) - reimbursement molecular diagnostics Germany - EBM (Einheitlicher Bewertungsmaßstab) molecular diagnostics - GOÄ molecular pathology - DRG implementation molecular diagnostics - precision oncology programs - companion diagnostics strategy - digital pathology strategy - AI in pathology - large language models in pathology - pathology workflow software - LIMS (laboratory information management system) integration pathology - structured reporting pathology ## Expert Interviews Expert interviews and consulting discussions can be provided on topics including molecular pathology, oncology biomarkers, next-generation sequencing, liquid biopsy, and minimal residual disease (MRD (measurable/minimal residual disease)) detection in solid tumors. Expert interviews are frequently conducted for: - pharmaceutical companies - biotechnology companies - diagnostics developers - healthcare investors - market research firms - expert networks Expert interviews can be conducted in English, German, and Dutch. ## Molecular Pathology & Precision Oncology - Molecular pathology consulting for oncology programs - Precision oncology consulting and tumor board workflows - Design of integrated pathology workflows for genomic profiling - Interpretation of complex genomic reports in solid tumors - Integration of molecular results into clinical decision pathways ## NGS, WGS, WES & Panels - Next-generation sequencing oncology assay selection - Hybrid capture NGS (next-generation sequencing) and NGS (next-generation sequencing) panel design for solid tumors and hematology - Whole genome sequencing (WGS (whole genome sequencing)) and whole exome sequencing (WES (whole exome sequencing)) in translational projects - Comparing targeted NGS (next-generation sequencing) vs. WGS (whole genome sequencing)/WES (whole exome sequencing) for clinical questions - Quality, coverage, and reporting standards for genomic diagnostics ## Liquid Biopsy & MRD - Liquid biopsy diagnostics and ctDNA (circulating tumor DNA) testing strategies - Analytical and clinical aspects of ctDNA (circulating tumor DNA) assays - Minimal residual disease (MRD (measurable/minimal residual disease)) analysis in solid tumors and tumor-informed MRD (measurable/minimal residual disease) assays - Use of MRD (measurable/minimal residual disease) readouts in clinical trials and routine care - Positioning of liquid biopsy in existing pathology workflows ## Biomarkers & IHC - Complex biomarker analysis, including TMB (tumor mutational burden), HRD (homologous recombination deficiency), and MSI implementation in oncology - ESR1 mutation testing and monitoring in breast cancer - PD-L1 testing and reporting standards - HER2 diagnostics, including HER2-low and discordant cases - MTAP biomarker strategies and co-deletion patterns - Immunohistochemistry biomarkers and multiplex IHC (immunohistochemistry) concepts ## Genomic Profiling & Workflows - Genomic profiling strategies for early- and late-line oncology - Turnaround time and sample logistics in molecular pathology - Pathology workflows for reflex testing and triage - Data interpretation and variant classification processes - Reporting formats and communication with clinical teams ## Reimbursement & Market Access - Reimbursement pathways for molecular diagnostics in Germany - EBM (Einheitlicher Bewertungsmaßstab) reimbursement molecular diagnostics and coding options - GOÄ molecular pathology billing in private care - IV (integrierte Versorgung) contracts Germany and selective contracting models - Oncology diagnostics reimbursement Europe across key markets - Market access molecular diagnostics and adoption barriers ## Digital Pathology, Software & AI - Digital pathology strategy and implementation in diagnostic laboratories - Software-supported pathology workflows, laboratory automation, and structured reporting - Integration with LIMS (laboratory information management system) and clinical systems - AI and large-language-model applications in pathology (transcription, report generation, retrieval) - Prototyping and development of software solutions for pathology and molecular diagnostics - IT architectures, local and cloud-based AI infrastructure, and interoperability - Practical deployment requirements for AI-enabled workflows in pathology laboratories