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Company Description

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301 Penobscot Drive

Redwood City, CA 94063

United States

Phone: 650-556-9300

Fax:

Genomic Health, Inc. provides genomic-based diagnostic tests that address the overtreatment and optimal treatment of early stage cancer. The company applies its scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from screening and surveillance, through diagnosis, treatment selection and monitoring, through its services and product portfolio that it collectively refer to as its Oncotype IQ Genomic Intelligence Platform. All of its testing services are made available through the company's clinical reference laboratory located in Redwood City, California. The company offers its Oncotype DX tests as a clinical laboratory service, where it analyzes the expression levels of genes in tumor tissue samples and provides physicians with a gene expression profile expressed as a single quantitative score, which it calls a recurrence score for invasive breast cancer and colon cancer, a ductal carcinoma in situ Score for DCIS and a Genomic Prostate Score, (GPS), for prostate cancer. Its Oncotype DX tests utilize quantitative genomic analysis known as reverse transcription polymerase chain reaction, (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the ‘oncotype’ of a tumor. Its Oncotype DX cancer tests analyze the expression levels of multiple genes across multiple biological pathways to predict cancer aggressiveness. The Oncotype DX breast cancer test has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit. Its Oncotype DX breast cancer test is also available for patients with DCIS, a pre-invasive form of breast cancer. The company’s Oncotype DX colon cancer test is the first multigene expression test developed to assess the risk of recurrence in patients with stage II disease, and is also available for use in patients with stage III disease treated with oxaliplatin-containing adjuvant therapy. Its Oncotype DX prostate cancer test has demonstrated that the multi-gene Oncotype DX GPS, assessed in prostate needle biopsy tumor tissue, is a predictor of adverse pathology for patients with early-stage prostate cancer. The company has a direct commercial presence with employees and consultants in the United States and certain other countries, and its tests are also available outside of the United States through a network of distributors. Oncotype DX Tests The company’s Oncotype DX tests utilize its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient’s tumor. The company offers Oncotype DX tests as clinical laboratory services, utilizing existing technologies, such as RT-PCR and information technologies and optimizes and integrates them into new processes. It expects to continue to extend the capabilities of the various components of its process to develop products. The company’s technologies allow it to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient’s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices. Oncotype DX Breast Cancer Test The company’s test for invasive breast cancer is designed to help identify those patients with higher risk disease who are most likely to benefit from chemotherapy and to identify those patients with lower risk disease who might receive minimal clinical benefit from chemotherapy. To develop its Oncotype DX breast cancer test, the company evaluated 250 genes in three independent clinical studies which identified a 21-gene panel whose composite gene expression profile could be represented by a breast cancer Recurrence Score. Oncotype DX Colon Cancer Test In developing its colon cancer product, the company used the same rigorous clinical development strategy and standardized quantitative technology designed for its

 

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