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New IHC Validation Guideline Improves Patient Safety by Ensuring Consistent Lab Test Results

Physicians and patients rely on accurate laboratory test results to guide treatment decisions. To ensure the accuracy of laboratory tests and reduce variation in laboratory practices, the College of American Pathologists has developed the first evidence-based guideline to validate all immunohistochemical (IHC) assays. The guideline, Principles of Analytic Validation of Immunohistochemical Assays, is now available in the online edition of Archives of Pathology & Laboratory Medicine.

ASCO and the CAP Release Updated Guideline on HER2 Testing in Breast Cancer

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.

Caris Life Sciences Launches Significant Enhancements to Industry-leading Cancer Tumor Profiling Service

Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, recently launched significant enhancements to its Molecular Intelligence™ tumor profiling service. These enhancements include significant updates to MI Portal™, the company’s online physician resource, a streamlined molecular profiling panel structure and the addition of two biomarkers.

Nuclea Bio Acquires Oncogene Science, Extends Deal with Wilex

Just a few months after announcing several new partnerships and landing venture capital dollars, Nuclea Biotechnologies Inc. has snapped up Oncogene Science, an Cambridge, Mass.-based subsidiary of Wilex AG in Germany.

Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.