Purpose
To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer.

/pdf/recommendations-for-human-epidermal-growth-factor-receptor-2-g57f9qz7g7.pdf

Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

Purpose.—To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in b...

/pdf/recommendations-for-human-epidermal-growth-factor-receptor-2-2ccp79orqo.pdf

Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update

The present invention provides multi-layer microfluidic systems, by providing additional substrate layers, e.g., third, fourth, fifth and more substrate layers, mated with the typically described first and second layers. Microfabricated elements, e.g., grooves, wells and the like, are manufactured into the surfaces between the various substrate layers. These microfabricated elements define the various microfluidic aspects or structures of the overall device, e.g., channels, chambers and the like. In preferred aspects, a separate microscale channel network is provided between each of the substrate layers.

Multi-layer microfluidic devices

HER2 (human epidermal growth factor receptor 2) receptor is a membrane tyrosine kinase and when activated affects cell proliferation and survival. The HER2 oncogene is located on chromosome 17q12. HER2 amplification is the primary pathway of HER2 receptor overexpression and is a major driver of tumor development and progression in a subset of breast cancers. HER2 is amplified in about 15% to 20% of breast cancers. The overexpressed HER2 receptor is a valuable therapeutic target. The 2007 ASCO guidelines mandate that HER2 should be evaluated in every invasive breast cancer, either at the time of diagnosis or recurrence to guide therapy. Currently HER2 testing is carried out by several methods. It is crucial to standardize testing techniques to accurately assess HER2 status. The aim of this review on HER2 in breast cancer is to discuss the important aspects of HER2 biology, its significance in breast cancer, and the current standards for its detection.

HER2 in breast cancer: a review and update.

HER2 or ErbB2 is a member of the epidermal growth factor family and is overexpressed in subsets of breast, ovarian, gastric, colorectal, pancreatic, and endometrial cancers. HER2 regulates signaling through several pathways (Ras/Raf/mitogen-activated protein kinase and phosphatidylinositol-3 kinase/protein kinase B/mammalian target of rapamycin pathways) associated with cell survival and proliferation. HER2-overexpressed and/or gene-amplified tumors are generally regarded as biologically aggressive neoplasms. In breast, cervical, endometrial, and ovarian cancer, there have been several studies linking the amplification of the c-erbB2 gene with chemoresistance and overall poor survival. Tyrosine kinase inhibitors and immunotherapy with monoclonal antibodies targeting HER2 hold promise for patients harboring these aggressive neoplasms. Trastuzumab combined with cytotoxic chemotherapy agents or conjugated with radioactive isotopes is currently being investigated in clinical trials of several tumor types.

HER2 Expression Beyond Breast Cancer: Therapeutic Implications for Gynecologic Malignancies

A test assembly for water-flow alarms having a housing made up of two sections. One section includes a control valve, and the other section a viewing chamber. The control valve is capable of a passing water therethrough at two distinct flow rates, one of which being equivalent to the flow rate passing through the orifice of a sprinkler. The viewing chamber contains a uniquely designed sight module therein through which the flow of water can be viewed. By incorporating the test assembly within a sprinkler system it is possible to reliably test a water-flow alarm without activating the sprinkler within the system.

Test assembly for water-flow alarms

The invention provides materials and methods for determining the aggressiveness of a cancer in a mammal. Specifically, the invention provides methods and methods for measuring the level of a TIEG marker in a sample. Such levels can be correlated with the aggressiveness of a cancer to predict patient outcome and develop treatment regimens.

Determining cancer aggressiveness

The importance of HER2 status in breast cancer management has focused attention on the ability of clinical assays to correctly assign HER2 amplification status. There is no consensus as to the best method for assessing HER2 status. Disadvantages of fluorescence in situ hybridization (FISH) testing include longer time required for staining and scoring slides, requirements for specialized training and fluorescence microscopy, and loss of the signal due to quenching of the fluorescent dye. Silver-enhanced in situ hybridization (SISH) is a rapid fully automated assay providing permanently stained slides that are interpreted by conventional bright field microscopy which enables pathologists to evaluate slides within the context of tissue morphology. This study evaluates the concordance between SISH and FISH assays in determining the status of HER2 gene amplification in a cohort of 298 primary invasive breast carcinomas. Furthermore, we assessed in detail the variables contributing to interobserver interpretive reproducibility of HER2 SISH among 10 pathologists. HER2 was quantified using the ratio of HER2 to CHR17 signals using the conventional historical interpretation scale and also by the American Society of Clinical Oncology/College of American Pathologists reporting scheme. For SISH status determined by consensus among 10 pathologists, overall concordance between SISH and FISH was identified in 288 of 298 cases (96.6%) using the conventional Food and Drug Administration approved criteria. Overall agreement was observed in 282 of 285 cases (98.9%) using the American Society of Clinical Oncology/College of American Pathologists result reporting scheme (with equivocal cases removed). In conclusion, SISH represents a novel approach for the determination of HER2 status in breast cancer. The overall concordance between SISH and FISH is excellent, and the interpretation of SISH results by pathologists is most reproducible using the HER2/CHR17 ratio.

Silver in situ hybridization (SISH) for determination of HER2 gene status in breast carcinoma: comparison with FISH and assessment of interobserver reproducibility.

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Test assembly for water-flow alarms

Determining cancer aggressiveness

Silver in situ hybridization (SISH) for determination of HER2 gene status in breast carcinoma: comparison with FISH and assessment of interobserver reproducibility.