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Background Fluorescence in situ hybridization (FISH) remains a gold standard for assessing gene amplification and deletion in clinical and translational oncology. Accurate evaluation of targets such as HER2 is critical for patient stratification, therapeutic response prediction, and inclusion in immunotherapy clinical trials. Discovery Life Sciences (Discovery) leverages CAP/CLIA-certified FISH services with deep expertise in probe design and analysis to support biopharma partners advancing precision oncology programs.Methods Discovery applies validated FISH assays using FDA-approved and custom probes to detect gene copy number changes, including HER2 amplification, in FFPE tissue sections. The assays are performed in a high-throughput environment, e.g. Dako Omnis, with experienced cytogenetic technologists and board-certified pathologists overseeing scoring and interpretation. Customizable workflows include dual-color and multi-target probe panels for simultaneous detection of amplifications, deletions, and structural rearrangements. These methods are integrated with matched IHC and NGS data for multi-modal biomarker development.Results Discovery has processed and analyzed over 1,000 oncology samples for HER2 amplification across multiple tumor types, including breast, gastric, and lung cancers. In parallel, the lab has deployed FISH panels for additional oncogenes and tumor suppressors, such as MYC, ALK, MET, and CDKN2A, to characterize genomic landscapes and identify patients most likely to benefit from targeted and immunotherapies. High concordance with orthogonal assays and clinical-grade QC metrics have supported inclusion of Discovery’s FISH data in regulatory submissions and clinical trial enrollment.Conclusions Discovery Life Sciences offers robust, scalable FISH testing for gene amplification and deletion, including established programs in HER2 analysis. These capabilities support the development and deployment of targeted therapies and immuno-oncology agents by enabling high-confidence patient selection and biomarker validation. The integration of FISH with other spatial and molecular platforms further enhances translational insights in immune-oncology.Ethics Approval Regulatory Approval. Discovery procures Biospecimens from its source sites pursuant to protocols approved by an Institutional Review Board (IRB)/Ethics Committee (EC) in accordance with applicable country-specific regulatory requirements. Consent Statuses: Biospecimens may be categorized as one of the following consent statuses: · Informed Consent: The subject has given written consent for participation. The consent meets all elements of informed consent as outlined in the Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR)21 CFR 50.25, or the applicable local regulatory standard if outside the United States. Waiver of Consent: The IRB/EC has approved the use of Biospecimens and/or data without written subject consent. In order to receive IRB/EC approval for waiver of consent, the study must satisfy all elements of 45CFR 46.116(f), or the applicable local regulatory standard if outside the United States.