Genomic Health
美國Genomic Health www.genomichealth.com
美國癌癥分子診斷市場第二大廠為Genomic Health約占美國癌癥分子診斷市場27.7%，且幾乎完全來自乳腺癌市場，它的Oncotype DXR.測試在早期乳腺癌病人中，能預測乳腺癌的續發可能性以及化療的效果，該公司以產品的差異化戰略取得了市場顯著的突破。
Genomic Health, a life science company founded in August of 2000 and located in Redwood City, California, is committed to improving the quality of cancer treatment decisions through the research, development and commercialization of genomic-based clinical laboratory services. To that end, the company conducts sophisticated genomic research to develop clinically-validated molecular diagnostics which provide individualized information on response to certain types of therapy, as well as the likelihood of disease recurrence. These diagnostic technologies generate information that healthcare providers and patients can use in making treatment decisions.
The pioneering work of Genomic Health in molecular diagnostics has led to the Oncotype DX Breast Cancer Assay, a laboratory test that analyzes the expression level of 21 genes in a woman’s breast tumor sample. It is the first and only gene expression test that has demonstrated the ability to predict a patient’s likelihood to benefit from chemotherapy as well as her risk of experiencing a disease recurrence. Oncotype DX is recommended in both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) clinical practice guidelines, including it in the standard of care for the majority of early-stage breast cancer patients.
At Genomic Health, we developed and follow a highly specialized process that not only adheres rigorously to CAP (College of American Pathologists) standards and CLIA (Clinical Laboratory Improvement Amendments) regulations, but also incorporates numerous real-time quality checks and periodic proficiency testing designed to produce a high level of accuracy in information that we deliver to physicians and patients.
Genomic Health is committed to compliance with applicable federal, state and local statutes and regulations that affect the operation of its business in its role as a provider of healthcare services, in order to conduct its activities with the utmost integrity and in accordance with the law. Genomic Health's compliance program furthers this commitment with internal controls and quality assurance processes that are designed to promote adherence to applicable federal and state laws.
Our Commitment as an Innovator in Personalized Oncology
We will put quality of care for patients first
We will use genomics to improve the quality of treatment decisions for patients
We will safeguard the privacy of patients’ genomic and health information
We will use state-of-the-art science and technology supported by rigorous clinical study and validation
We will work to provide access to our tests for all appropriate patients
