Designing good studies is essential. Experiments must work in order to generate the results you need. This requires more than just following recipes – you must validate your protocols and assays, as well as the antibodies, and reagents you use – whether they were developed in your lab for research, are under development as new products, or are under development for diagnostics or other testing applications. For tissue-based tests such as IHC/antibody studies, FISH, in situ gene expression analysis, imaging/cell morphology, and others, validation must be performed against a full panel of properly typed and matched tissue samples. Doing this will enable you to achieve the following desired results:
Consistency. Confirm consistent behavior and response across the full range of tissue and cell types, patient backgrounds, tissue collection sites and methods, etc.
Variation Analysis. Determine variation in signal and background detection across diverse tissue and cellular samples.
Disease-specific markers and changes. For cancer and other disease studies, it is important to characterize the range of differences in signal detection in the normal versus disease samples overall, and at the cellular level, as well as identify any factors associated with assay errors (false positives and negatives).
Assays and Reagents. For assays and reagents designed or being tested for ability to differentiate sub-populations within a disease population – for example, receptor status, protein phosphorylation state, gene/protein expression, chromosome translocation, or other biomarkers used to identify and select clinical patient subsets – it is important to validate the methods on sufficiently large and diverse sample sets. To accomplish this efficiently, you need a biobank as rich as Folio’s to get enough samples properly qualified and annotated with the disease state and other clinical characteristics, as well as possible outcome information. Folio has the number of samples required for good study design and experimental significance, and it will provide all of the diversity – or commonality – you need for your tissue samples.
Biomarker discovery. Discover new biomarkers or disease states that associate with your assay – for example, other proteins with similar or opposite changes in expression or localization within all, or specific, tissue and cell types, cellular morphology, or specific diseases or populations with consistently different patterns of detection.
Assay parameters. Determine the sensitivity and specificity of your assays, antibodies, and other reagents across a large, diverse, but well-matched set of tissue samples from the Folio Biosciences biobank.
Secondary screens. Once you have taken the steps to optimize your assays for the desired test, you can repeat them on the same samples from Folio. If you need more of specific cases, it can reserve the blocks for you from the sections provided, or it can help you widen/narrow the tissue selection to validate your final methods and reagents – for example, specific antibodies and combinations.