Daniel Kazdal
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View article: Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview
Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union—a comparative overview Open
Process chains in medical diagnostic laboratories lead to an accurate diagnosis and consequently to optimized personalized therapy recommendations. In addition to approved commercial in vitro diagnostic medical devices, devices and tests m…
View article: Whole Exome Sequencing on FHIR: Towards Adoption in Clinical Practice for Precision Oncology Pipelines
Whole Exome Sequencing on FHIR: Towards Adoption in Clinical Practice for Precision Oncology Pipelines Open
Introduction: Whole Exome Sequencing (WES) promises to open a new range of personalized treatments due to breaking the limits of former panel-based methods of molecular analysis. While the methodology is well established and already includ…
View article: 155eP Microcosting analysis of combined whole genome sequencing and whole transcriptome sequencing in cancer diagnostics
155eP Microcosting analysis of combined whole genome sequencing and whole transcriptome sequencing in cancer diagnostics Open
View article: Differentiating Main-Duct IPMN from Chronic Pancreatitis Using Next-Generation Sequencing of Main Pancreatic Duct Fluid: A Pilot Study
Differentiating Main-Duct IPMN from Chronic Pancreatitis Using Next-Generation Sequencing of Main Pancreatic Duct Fluid: A Pilot Study Open
Background: A dilated main pancreatic duct (MPD) ≥ 5 mm can be observed in main-duct IPMNs (MD-IPMN) and chronic pancreatitis (CP); however, distinguishing between the two differently treated diseases can be difficult. Cell-free (cf) DNA i…
View article: Impact of Baseline β-Catenin Comutations on Prognosis in EGFR-Mutant Lung Cancer
Impact of Baseline β-Catenin Comutations on Prognosis in EGFR-Mutant Lung Cancer Open
PURPOSE Epidermal growth factor receptor (EGFR) mutations are a main actionable driver in non–small cell lung cancer (NSCLC). However, the clinical significance of catenin beta-1 (CTNNB1) comutations remains unclear. This study evaluated o…
View article: CG>TG mutation frequency as negative predictor of homologous recombination deficiency in ovarian and breast cancer
CG>TG mutation frequency as negative predictor of homologous recombination deficiency in ovarian and breast cancer Open
View article: Corrigendum to “A reproducibility study on invasion in small pulmonary adenocarcinoma according to the WHO and a modified classification, supported by biomarkers” [Lung Cancer 199 (2025) 108060]
Corrigendum to “A reproducibility study on invasion in small pulmonary adenocarcinoma according to the WHO and a modified classification, supported by biomarkers” [Lung Cancer 199 (2025) 108060] Open
The authors wish to inform the readers that the correct authors list and affiliations of all the authors have been updated as above. The authors have identified an error in the legend of Figure 5. The legend should be replaced with “Figure…
View article: Comprehensive genomic profiling requires a blended ecosystem of learning healthcare and clinical trials
Comprehensive genomic profiling requires a blended ecosystem of learning healthcare and clinical trials Open
View article: Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing Open
Current European/US guidelines recommend that molecular testing in advanced non‐small cell lung cancer (aNSCLC) be performed using next‐generation sequencing (NGS). However, the global uptake of NGS is limited, largely owing to reimburseme…
View article: Biopsy‐derived organoids in personalised early breast cancer care: Challenges of tumour purity and normal cell overgrowth cap their practical utility
Biopsy‐derived organoids in personalised early breast cancer care: Challenges of tumour purity and normal cell overgrowth cap their practical utility Open
The ability to establish organoids composed exclusively of tumour rather than healthy cells is essential for their implementation into clinical practice. Organoids have recently emerged as a powerful tool to expand patient material in cult…
View article: A reproducibility study on invasion in small pulmonary adenocarcinoma according to the WHO and a modified classification, supported by biomarkers
A reproducibility study on invasion in small pulmonary adenocarcinoma according to the WHO and a modified classification, supported by biomarkers Open
The modified classification demonstrates essentially higher reproducibility compared to the current WHO classification in NMA. The modified classification proves valuable in identifying low-risk lesions that are entirely non-invasive, and …
View article: A novel clinical brain prognostic index for KRAS-mutated lung cancer and brain metastases (KRAS-BPI): Real-world evidence from two large European centers
A novel clinical brain prognostic index for KRAS-mutated lung cancer and brain metastases (KRAS-BPI): Real-world evidence from two large European centers Open
In the largest real-word data study of KRAS-mutated NSCLC patients with BM, we developed a novel prognostic tool for improved patient stratification.
View article: Clinical Implementation of a High-Throughput Automated Comprehensive Genomic Profiling Test
Clinical Implementation of a High-Throughput Automated Comprehensive Genomic Profiling Test Open
View article: Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika
Die Pathologie im Rahmen des europäischen und nationalen Medizinprodukterechts: Betrieb, Anwendung und Eigenherstellung von In-vitro-Diagnostika Open
Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation …
View article: 118P Whole transcriptome sequencing of lung tissue to combine disease classification and identification of actionable targets
118P Whole transcriptome sequencing of lung tissue to combine disease classification and identification of actionable targets Open
View article: 131P Benchmarking whole exome sequencing in the German network for personalized medicine
131P Benchmarking whole exome sequencing in the German network for personalized medicine Open
View article: KRAS and TP53 co-mutation predicts benefit of immune checkpoint blockade in lung adenocarcinoma
KRAS and TP53 co-mutation predicts benefit of immune checkpoint blockade in lung adenocarcinoma Open
View article: Leveraging Off-Target Reads in Panel Sequencing for Homologous Recombination Repair Deficiency Screening in Tumor
Leveraging Off-Target Reads in Panel Sequencing for Homologous Recombination Repair Deficiency Screening in Tumor Open
Targeted tumor only sequencing has become a standard practice in cancer diagnostics. This study aims to develop an approach for robust copy number variant calling in tumor samples using only off-target region (OTR) reads. We also establish…
View article: The pregnancy-associated protein glycodelin as a potential sex-specific target for resistance to immunotherapy in non-small cell lung cancer
The pregnancy-associated protein glycodelin as a potential sex-specific target for resistance to immunotherapy in non-small cell lung cancer Open
View article: High Concordance of Different Assays in the Determination of Homologous Recombination Deficiency–Associated Genomic Instability in Ovarian Cancer
High Concordance of Different Assays in the Determination of Homologous Recombination Deficiency–Associated Genomic Instability in Ovarian Cancer Open
PURPOSE Poly(ADP-ribose) polymerase inhibitors (PARPi) have shown promising clinical results in the treatment of ovarian cancer. Analysis of biomarker subgroups consistently revealed higher benefits for patients with homologous recombinati…
View article: 54P Efficacy of first-line immunotherapy for non-small cell lung cancer with MET exon 14 skipping according to PD-L1 expression
54P Efficacy of first-line immunotherapy for non-small cell lung cancer with MET exon 14 skipping according to PD-L1 expression Open
Background METΔ14ex is the driver alteration for approximately 3% of non-small cell lung cancers (NSCLC) and associated with a higher PD-L1 expression, but unclear benefit from immunotherapy (IO). Methods Seventy-eight consecutive patients…
View article: First-line immunotherapy for lung cancer with MET exon 14 skipping and the relevance of TP53 mutations
First-line immunotherapy for lung cancer with MET exon 14 skipping and the relevance of TP53 mutations Open
View article: Genomic heterogeneity at baseline is associated with <scp>T790M</scp> resistance mutations in <i>EGFR</i>‐mutated lung cancer treated with the first‐/second‐generation tyrosine kinase inhibitors
Genomic heterogeneity at baseline is associated with <span>T790M</span> resistance mutations in <i>EGFR</i>‐mutated lung cancer treated with the first‐/second‐generation tyrosine kinase inhibitors Open
This study analyzed whether extended molecular profiling can predict the development of epidermal growth factor receptor ( EGFR ) gene T790M mutation, which is the most frequent resistance alteration in non‐small cell lung cancer (NSCLC) a…
View article: A Reproducibility Study on Invasion in Small Pulmonary Adenocarcinoma According to the Who and a Modified Classification, Supported by Biomarkers
A Reproducibility Study on Invasion in Small Pulmonary Adenocarcinoma According to the Who and a Modified Classification, Supported by Biomarkers Open
View article: Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology
Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology Open
View article: PL03.07 Invasion or No Invasion, That’s the Question. A Large Reproducibility Study in Pulmonary Adenocarcinoma, Supporting a Modified Classification
PL03.07 Invasion or No Invasion, That’s the Question. A Large Reproducibility Study in Pulmonary Adenocarcinoma, Supporting a Modified Classification Open
View article: Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial
Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary: a phase II trial Open
View article: Multicentric pilot study to standardize clinical whole exome sequencing (WES) for cancer patients
Multicentric pilot study to standardize clinical whole exome sequencing (WES) for cancer patients Open
A growing number of druggable targets and national initiatives for precision oncology necessitate broad genomic profiling for many cancer patients. Whole exome sequencing (WES) offers unbiased analysis of the entire coding sequence, segmen…
View article: Current challenges and practical aspects of molecular pathology for non-small cell lung cancers
Current challenges and practical aspects of molecular pathology for non-small cell lung cancers Open
View article: Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie
Die Verordnung (EU) 2017/746 (IVDR) in der Praxis: Umsetzung von Anhang I in der Pathologie Open