Background
Historically, immunohistochemistry (IHC) assays have been designed for simplicity of manual pathology, however, this is not always ideal to acquire the appropriate data for patient selection and outcomes. Due to various challenges within the current pathology scoring paradigms and the increasing complexity of biomarker strategies for patient enrollment, advancements in this field is required. Particularly the movement of clinical diagnostics (CDx) into the digital age is needed to allow for data-driven approaches. Flagship Biosciences, Inc. provides a tissue and biomarker analysis platform that gives an advantage to drug development and clinical diagnostics.
Flagship Biosciences, Inc. has an in-house developer team that is at the forefront of innovation with the capability to provide end-to-end biomarker assays and analysis for clinical trials and regulatory management. Our central site allows for custom and complex assay design, as well as reliable and validated imaging criteria in normal tissues and many disease types (e.g. oncology, muscle, liver, and neuronal). Our proprietary image analysis (IA) platform allows for the collection of many data endpoints, from simple to complex with the flexibility and adaptability to create new capabilities when required. Operation of the IA platform is performed by dedicated engineers intricately familiar with the platform to get the most of out of it, ensuring high-quality data. Furthermore, IA data yields comparable results to pathologist interpretation but eliminates the intra-pathologist and inter-pathologist variability associated with manual scoring.