Genomic Health, Inc., a global healthcare company, provides genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer. 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 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. Its Oncotype DX cancer tests analyze the expression levels of multiple genes across multiple biological pathways to predict cancer aggressiveness. The company’s research and development activities are focused on developing a pipeline of tests to optimize the treatment of urologic cancers, including bladder and kidney cancers, as well as additional treatment decisions in breast, colon and prostate cancers. As of December 31, 2014, approximately 19,000 physicians in approximately 70 countries had ordered approximately 500,000 Oncotype DX tests. 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 provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score for invasive breast cancer and colon cancer, a DCIS Score for ductal carcinoma in situ, or DCIS and a Genomic Prostate Score, or GPS, for prostate cancer. Patents and Proprietary Technology As of December 31, 2014, the company had 39 issued patents in the United States and 85 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 validated each patent in key European Union countries. In addition, the company 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. In these patent applications, it has either sole or joint ownership positions. 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 As of December 31, 2014, the company’s research and development expenses included $56.1 million. Competition The company faces competition from companies that offer products or have conducted research to profile genes, gene expression or protein expression in breast, colon or prostate cancer, including public companies, such as, GE Healthcare, a business unit of General Electric Company; Hologic, Inc.; Myriad Genetics, Inc.; NanoString Technologies, Inc.; Novartis AG; Qiagen N.V.; and Response Genetics, Inc. The company faces competition from commercial laboratories with distribution networks for diagnostic tests, such as Laboratory Corporation of America Holdings and Quest Diagnostics Incorporated. 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 the Clinical Laboratory Improvement Amendments of 1988 (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:NASDAQ GS)
301 Penobscot Drive
Redwood City, CA 94063
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