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1. 2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies)

2. 2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)

4. Supplementary Table 1 from A High Frequency of Activating Extracellular Domain ERBB2 (HER2) Mutation in Micropapillary Urothelial Carcinoma

5. Supplementary Table S1. from Relapsed Classic E-Cadherin (CDH1)–Mutated Invasive Lobular Breast Cancer Shows a High Frequency of HER2 (ERBB2) Gene Mutations

6. Supplementary Data from Relapsed Classic E-Cadherin (CDH1)–Mutated Invasive Lobular Breast Cancer Shows a High Frequency of HER2 (ERBB2) Gene Mutations

7. Supplementary Figure 1 from A High Frequency of Activating Extracellular Domain ERBB2 (HER2) Mutation in Micropapillary Urothelial Carcinoma

9. Suppression of heat shock protein 27 induces long-term dormancy in human breast cancer

11. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing

14. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies

17. Abstract 4989: Introduction of a robust workflow for the whole-side acquisition and co-registration of multiplex immunofluorescence tissue images for analysis of a 9-color, 8-marker immunophenotyping assay

26. Colchicine, aspirin, and montelukast – A case of successful combined pharmacotherapy for adult multisystem inflammatory syndrome in COVID-19.

30. New method for immunoprofiling of the tumor microenvironment of cancer patients by opal multiplex quantitative immunofluorescence (IF) assay

31. Abstract 4699: Analytical validation of solid tumor fusion gene detection in a comprehensive NGS-based clinical cancer genomic test

32. Response of an ERBB2-Mutated Inflammatory Breast Carcinoma to Human Epidermal Growth Factor Receptor 2–Targeted Therapy

33. Clinical application of comprehensive next-generation sequencing-based genomic profiling for identification of actionable genomic alterations in pediatric solid tumors and hematolymphoid malignancies: The Foundation Medicine pediatric experience.

34. Comprehensive Genomic Profiling of Relapsed and Metastatic Adenoid Cystic Carcinomas by Next-generation Sequencing Reveals Potential New Routes to Targeted Therapies

35. A High Frequency of Activating Extracellular Domain ERBB2 (HER2) Mutation in Micropapillary Urothelial Carcinoma

37. Abstract B122: A high frequency of activating extracellular domain ERBB2 (HER2) mutation in micropapillary urothelial carcinoma.

38. Use of next-generation sequencing (NGS) to identify actionable genomic alterations (GA) in diverse solid tumor types: The Foundation Medicine (FMI) experience with 2,200+ clinical samples.

39. Use of the FoundationOne next-generation sequencing (NGS) assay to detect actionable alterations leading to clinical benefit of targeted therapies for relapsed and refractory breast cancer.

40. Relapsed Classic E-Cadherin (CDH1)–Mutated Invasive Lobular Breast Cancer Shows a High Frequency of HER2 (ERBB2) Gene Mutations

41. Targeted Next-generation Sequencing of Advanced Prostate Cancer Identifies Potential Therapeutic Targets and Disease Heterogeneity

42. Abstract 2279: Bringing next generation sequencing (NGS) to the clinic: Analytical validation of a comprehensive NGS-based cancer gene test.

43. Use of next-generation sequencing (NGS) to detect a novel ALK fusion and a high frequency of other actionable alterations in colorectal cancer (CRC).

44. Targeted next-generation sequencing (NGS) of advanced prostate cancer (PCA) using formalin-fixed tissue.

45. Abstract 5074: Massively parallel DNA-sequencing of aggressive prostate cancer reveals disease heterogeneity and identifies targetable mutations

46. Abstract 967: Massively parallel sequencing of clinical FFPE cancer specimens enables comprehensive genomic assessment of patient eligibility for targeted therapy

47. Abstract C22: Massively parallel DNA-sequencing of aggressive prostate cancer reveals disease heterogeneity and identifies targetable mutations

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