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Bayer HealthCare to Collaborate with Sysmex Inostics GmbH to Develop Blood-based Companion Diagnostic Tests in Oncology

Bayer HealthCare has entered into a master collaboration agreement with the diagnostic company Sysmex Inostics GmbH for the development of companion diagnostics for targeted cancer therapies. The innovative blood-based companion diagnostic solutions offered by Sysmex Inostics will complement anti-cancer agents developed by Bayer.

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.

Personalized Medicine Roadmap: Definiens Releases Five Steps to Utilize Data Mining with Image Analysis

Definiens, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, recently released tips for integrating data mining with image analysis. As pathologists, researchers and clinicians seek to advance personalized medicine through the development and prescription of targeted therapies, data generated through image analysis of digitized tissue sections is becoming essential to stratifying patients and providing personalized care.

Life Technologies and Advanced Cell Diagnostics Sign Global Distribution Agreement

Life Technologies Corporation (NASDAQ: LIFE) and Advanced Cell Diagnostics, Inc. (ACD), a leader in the field of molecular pathology and developer of cell and tissue-based analysis tools, recently announced a global distribution agreement by which Life will distribute ACD’s fluorescent RNAscope® portfolio of probes and kits to the research market through its worldwide distribution network.

FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.