Genomic Health, Inc., a global healthcare company, provides actionable genomic information to personalize cancer treatment decisions. Oncotype DX Platform The company’s Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction, or RT-PCR, in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. 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. The company analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices. 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 quantitative gene expression profile expressed as a single quantitative score. The company’s Oncotype DX breast cancer test analyzes the expression levels of 21 genes and its Oncotype DX colon cancer test analyzes the expression levels of 12 genes. Its Oncotype DX prostate cancer test measures the level of expression of 17 genes across 4 biological pathways to predict prostate cancer aggressiveness in men with low risk disease. All of the company’s testing services are made available through its clinical reference laboratory located in Redwood City, California, which is accredited under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and by the College of American Pathologists. As of December 31, 2013, approximately 19,000 physicians in approximately 70 countries had ordered approximately 420,000 Oncotype DX tests. The company has a direct commercial presence with employees and consultants in the United States and certain other countries, and its Oncotype DX breast and colon cancer tests are also available outside of the United States through a network of distributors. In 2013, the company initiated the first clinical treatment decision impact study of its biopsy-based prostate cancer test. The company has two contracts to perform clinical studies to demonstrate the value of the Oncotype DX prostate cancer test in patients on active surveillance The company’s research and development activities are focused on developing a pipeline of tests to optimize the treatment of urologic cancers, including prostate, bladder and kidney cancers, as well as additional treatment decisions in breast and colon cancers. The company has a direct commercial presence with employees and consultants in a number of countries, including Canada, France, Germany, Ireland, Italy, Japan, the Netherlands, Switzerland and the United Kingdom. Additionally, it has exclusive distribution agreements for one or more of its Oncotype DX tests with approximately 20 distributors covering approximately 90 countries. Competition The company competes with GE Healthcare, a business unit of General Electric Company; Hologic, Inc.; Myriad Genetics, Inc.; NanoString Technologies, Inc.; Novartis AG; Qiagen N.V.; Response Genetics, Inc.; Laboratory Corporation of America Holdings; and Quest Diagnostics Incorporated. Patents and Proprietary Technology As of December 31, 2013, the company had 32 issued patents in the United States and 65 issued patents outside of the United States covering genes and methods that are components of the Oncotype DX breast, colon and prostate cancer tests or research methods and platform technologies. For patents issued by the European Patent Office, the company has validated each patent in key European Union countries. In addition, it has various pending patent applications in the United States and in other countries, including provisional and non-provisional filings. The company’s issued U.S. patents expire at various times between 2023 and 2032. Some of these U.S. patent applications also have corresponding pending or granted applications under the Patent Cooperation Treaty in Canada, Europe, Japan, Australia and other jurisdictions. Agreements The company licenses from Roche Molecular Systems, Inc., on a non-exclusive basis, a number of U.S. patents claiming nucleic acid amplification processes known as PCR, homogeneous PCR, and RT-PCR. It uses these processes in its research and development activities and in the processing of its Oncotype DX tests. Research and Development Expenses The company’s research and development expenses were $66.3 million for the year ended December 31, 2013. Regulation As a clinical reference laboratory, the company is required to hold certain federal, state and local licenses, certifications and permits to conduct its business. Under CLIA, the company is required to hold a certificate applicable to the type of work it performs and to comply with standards covering personnel, facilities administration, quality systems and proficiency testing. Clinical laboratory tests like the company’s Oncotype DX tests are regulated under CLIA, as administered by the Centers for Medicare and Medicaid Services, as well as by applicable state laws. Diagnostic that are sold and distributed through interstate commerce are regulated as medical devices by the Food and Drug Administration. The company is subject to the federal physician self-referral prohibitions, commonly known as the Stark Law, and to similar restrictions under California's Physician Ownership and Referral Act. History Genomic Health, Inc. was founded in 2000. The company was incorporated in Delaware in 2000.
genomic health inc
(GHDX:Consolidated Issue Listed on NASDAQ Global Select )
301 Penobscot Drive
Redwood City, CA 94063
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