Flagship Biosciences, Inc. is the global leader in quantitative tissue image analysis solutions that help bio/pharmaceutical companies define their path to success. Flagship’s Computational Tissue Analysis (cTA™) platform provides the quantitative, contextual tissue interpretations necessary to make timely decisions, creating an indispensable partnership with bio/pharma companies in their development of novel drugs, especially in immuno-oncology (I/O). The proprietary cTA platform allows for the evaluation and interrogation of tissues using a patented cell-based approach to deliver the most biologically relevant quantification endpoints required for drug discovery, development and patient stratification. Flagship offers its partners a continuous tissue image analysis technical pathway, from drug discovery through commercialization. Leveraging a unique combination of its technology platform, extensive expertise across multiple disciplines (e.g., pathology, biology, image analysis, software engineering), and an in-house CLIA lab, Flagship is developing quantitative tissue biomarker interpretations for clinical development of tissue-based diagnostics, including companion diagnostics (CDx). Over 100 pharmaceutical, biotech, and medical device firms rely on Flagship's technology for success. As the largest clinical tissue-image-analysis operation in the US, Flagship has completed over 400 projects since 2009.
Exploratory endpoints for clinical trials are developed and validated in our GCP laboratory, and can be transitioned to CLIA validated biomarker selection approaches in our CLIA laboratory for patient selection hypothesis testing or PMA registration trials. Flagship’s proprietary tools and laboratory infrastructure are designed to create the high complexity, quantitative, in situ assay needed for targeted therapy and immuno-oncology patient selection approaches. Our in house quality assurance for clinical trials, regulatory affairs, and FDA Quality Manufacturing groups ensure that the image analysis approaches we create for the exploratory setting can be successfully transitioned into companion diagnostic devices.
Tumor biomarker heterogeneity is a major confounding variable in clinical and research oncologists. Flagship's proprietary heterogeneity tools report application-specific measurements which describe the effect of heterogeneity on a tissue measurement.
Flagship's cellular analysis tools are an effective approach to quantifying chromogenic in situ hybridization markers in a wide range of tissue and disease types. Using dot based algorithms, we classify signals into individual cells, and quantify RNA signals using dot intensity, dot size, and aggregate parameters.
Immuno-oncology approaches demand the interpretation of multiple types of cells characterized by multiple biomarkers in the context of their relationship to each other. Flagship’s proprietary approaches designed to meet these specific demands are capable of measuring these sophisticated contextual relationships.
Evaluating RNA expression in the localized tissue context is a valuable addition to many pharmaceutical companion diagnostics and research programs. Automation of this approach utilizing autostainers increases the reproducibility of these approaches, but requires strong working knowledge of the equipment and assays to be successful. This requires expertise unique to the technology and an understanding of the expected results. Flagship has extensive experience in developing, validating, and measuring RNA using in situ hybridization. This approach is maximized by the benefits of image analysis based quantification, using our novel approaches designed specifically for this technically challenging application.
We develop high quality chromogenic and fluorescent immunohistochemistry assays for quantitative endpoints. Our approach creates the best fit-for-purpose solution to match your intended use of an assay, and provides you with the most robust and relevant results. For drug discovery, basic exploratory research assays are quickly developed in our IHC laboratory to meet the proper performance criteria needed for prevalence studies, xenograft studies, and basic biomarker hypothesis testing. In the clinical trial exploratory setting, we develop assays which meet the guidelines defined under Good Clinical Laboratory Practice (GCLP) standards for conducting laboratory testing using specimens from IND-registered clinical trials. If a clinical trial requires patient enrollment activities, we validate assays in our CLIA laboratory and provide sample processing/reporting within your timeline.
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