Emerging biomedical imaging-based companion diagnostics for precision medicine [PDF]
iScience, 2023 Summary: The tumor heterogeneity, which leads to individual variations in tumor microenvironments, causes poor prognoses and limits therapeutic response.
Shiyi Liao +8 more
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Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS [PDF]
Molecular Therapy: Methods & Clinical Development, 2023 Companion diagnostics (CDx), which is essential in precision medicine, is changing to a personalized treatment approach. CDx is a test that identifies patients who can benefit from a specific drug and those who experience side effects of drugs for safe ...
Su Lim Kang +4 more
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The current landscape of the FDA approved companion diagnostics [PDF]
Translational Oncology, 2021 Predictive biomarker is an important element in the realization of precision medicine and with the introduction of the drug-diagnostic codevelopment model, the number of regulatory approved companion diagnostics (CDx) have steadily increased.
Jan Trøst Jørgensen
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Companion Diagnostics: State of the Art and New Regulations [PDF]
Biomarker Insights, 2021 Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro ...
Vasiliki Valla +5 more
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Clinical utility of liquid biopsy-based companion diagnostics in the non-small-cell lung cancer treatment [PDF]
Exploration of Targeted Anti-tumor Therapy, 2022 Recently, technological advances in the detection and biological characterization of circulating tumor DNA (ctDNA) have enabled the implementation of liquid biopsy testing into clinical practice.
Yoshiharu Sato
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Analytical Performance of a Highly Sensitive System to Detect Gene Variants Using Next-Generation Sequencing for Lung Cancer Companion Diagnostics [PDF]
Diagnostics, 2023 The recent increase in the number of molecular targeted agents for lung cancer has led to the demand for the simultaneous testing of multiple genes. Although gene panels using next-generation sequencing (NGS) are ideal, conventional panels require a high
Kikuya Kato +8 more
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Companion Diagnostics (CDx) Based on Molecular Biology Techniques [PDF]
LifeMolecular profiling based on genomic mutations provides clinically important diagnostic and prognostic information. Companion diagnostic (CDx) testing, which is based on targeted drug therapy, is being applied to a variety of molecular diagnostic ...
Su Lim Kang, Ji Yean Kwon, Sung Min Kim
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Development of Companion Diagnostics. [PDF]
Semin Nucl Med, 2016 The goal of individualized and targeted treatment and precision medicine requires the assessment of potential therapeutic targets to direct treatment selection. The biomarkers used to direct precision medicine, often termed companion diagnostics, for highly targeted drugs have thus far been almost entirely based on in vitro assay of biopsy material ...
Mankoff DA +3 more
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In situ protein detection for companion diagnostics [PDF]
Frontiers in Oncology, 2013 The emergence of targeted therapies for cancer has created a need for the development of companion diagnostic tests. Assays developed in recent years are aimed at determining both the effectiveness and safety of specific drugs for a defined group of ...
Gabriela eGremel +4 more
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A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics [PDF]
Frontiers in Genetics, 2016 Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics.
Dee eLuo +15 more
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