New Pathology
Molecular Pathology and Precision Oncology Consulting
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.
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.
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 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.
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.
Biomarkers & Technologies
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
- NGS panel design for oncology, including targeted panels and comprehensive genomic profiling.
- Whole genome sequencing (WGS) and whole exome sequencing (WES) in translational oncology projects.
- Liquid biopsy diagnostics and ctDNA testing strategies, from feasibility to routine clinical adoption.
- MRD in solid tumors, including the design and interpretation of tumor-informed MRD assays and longitudinal monitoring concepts.
Biomarker portfolio
- Development and positioning of TMB biomarker and HRD biomarker assays in clinical and reimbursement contexts.
- ESR1 mutation testing and ctDNA-based ESR1 monitoring in hormone receptor-positive breast cancer strategies.
- PD-L1 testing, HER2 diagnostics (including HER2-low), and MTAP biomarker integration into diagnostic workflows.
- Immunohistochemistry biomarkers and combined IHC/NGS approaches in pathology practice.
Germany & Europe
Reimbursement & Market Access
Advisory support covers reimbursement pathways and market access considerations for molecular diagnostics, particularly in Germany and Europe. The focus is on realistic implementation, adoption barriers, and the interaction between evidence generation, clinical utility, and reimbursement decisions.
Germany: reimbursement structures
- Orientation on EBM reimbursement molecular diagnostics and coding options for oncology testing.
- Discussion of GOÄ molecular pathology billing in private care settings.
- Considerations around IV contracts Germany and selective contracts for molecular diagnostics.
- High-level advisory on molecular diagnostics reimbursement Germany in the context of precision oncology programs.
Market access and adoption
- Oncology diagnostics reimbursement Europe and differences across key markets from an expert perspective.
- Market access molecular diagnostics considerations for new biomarkers and companion diagnostics.
- Adoption barriers, implementation realities, and stakeholder expectations in hospital and laboratory settings.
- How clinical evidence, utility, and health-economic data influence reimbursement decisions for advanced oncology tests.
About
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.
Languages
Consulting projects, advisory work, and expert interviews can be conducted in English , German, and Dutch.
Contact
For consulting inquiries regarding molecular pathology, precision oncology, biomarkers, genomic diagnostics, or reimbursement and market access:
In English: Lukas C Heukamp, MB PhD BSc (Hons) consulting@newpathology.de
Auf Deutsch: PD Dr. Lukas C Heukamp beratung@newpathology.de