Cell yield for synthetic tissue controls and synthetic tissue microarray controls

Abstract

Pathology testing and clinical laboratory testing are important aspects of modern diagnostic and prognostic practices. Control samples are often used to maintain quality control (QC) for reproducibility of test results by immunohistochemical (IHC) staining, in situ hybridization (ISH), and other methods of molecular analyses. Some of the controls available for IHC staining and ISH staining of tumor tissues and other diseased tissues are cancer tissue-derived controls. However such types of controls are only available in very limited quantities, and once such controls are exhausted, replacementcontrols with the same characteristics may be unavailable. Other types of available controls are cancer cell lines-derived controls. However, such types of controls do not exhibit consistent patternsand levels of cellular expression of a given marker, or heterogeneity of said expression, which is ubiquitous to tumor tissues. As such, these controls have little or no morphological resemblance toactual tumor tissues. Further, conventional techniques to form controls involve processes that produce poor yield, thereby requiring significant amounts of cultured cells in order to form such controls, thereby increasing productivity costs and decreasing productivity efficiency.

Description

[0001] Background of the invention

[0002] Pathological testing and clinical laboratory testing are important aspects of modern diagnostic and prognostic practice. Control samples are often used to maintain quality control (QC) to ensure reproducibility of test results for immunohistochemical (IHC) staining, in situ hybridization (ISH), and other molecular analysis methods.

[0003] Some of the controls available for IHC staining and ISH staining of tumor tissue and other diseased tissues are cancer tissue-derived controls. However, the number of controls of this type is very limited, and once such controls are exhausted, it may be difficult to obtain replacement controls with the same characteristics. Another type of control that can be used is a control derived from a cancer cell line. However, controls of this type did not exhibit consistent cellular expression patterns and levels of a given marker, or the heterogeneity of said expression, which is ubiquitous in tumor tiss...

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