Frequently Asked Questions
Genomic Health conducts sophisticated genomic studies and research to develop and commercialize clinically-validated molecular diagnostic tests, which provide individualized information on response to certain types of cancer therapy and the likelihood of disease recurrence. Molecular diagnostic testing generates information that healthcare providers and patients can use in making more informed treatment decisions.
Genomics is the study of complex sets of genes, how they are expressed (their level of activity) and the role they play in biology and disease.
The Human Genome Project helped identify and sequence the full set of genes in the human body, but it did not provide sufficient information to impact treatment planning for cancer. Actionable insights come from knowing the genes’ relative expressions and their impact on disease recurrence and/or benefit from treatment, not simply their sequences or forms.
As the study of genomics advances, the application of genomic information is expected to enhance the diagnosis, prognosis and treatment and prevention of many different diseases.
In oncology, “personalized” or “individualized” medicine (or treatment) refers to the utilization of tests such as those Genomic Health has developed/is developing to determine which sets of genes and gene interactions can be reliably used to predict an individual patients’ likely response to therapy or the likelihood of disease recurrence. The use of clinically validated molecular diagnostic testing services that provide the genomic profile of an individual's tumor enable healthcare providers and patients to better understand what treatments are most likely to work for that patient or how likely a cancer is to spread or return.
The company was founded with a focus on cancer because of the belief that there is an urgent need and immediate opportunity to develop molecular diagnostic testing to impact the quality of care and quality of life for cancer patients and their families.
An individual cancer contains many different alterations—it is not the same disease for every patient. As a result, some patients may be more or less likely to develop advanced disease or to respond to certain therapies. Until recently, we have had only limited insight into these differences at a patient’s initial diagnosis, which limited clinicians’ ability to choose a treatment tailored to the individual patient.
This is where genomics—the study of complex sets of genes, their expression and their functions—comes in. Genomic Health is developing new genomic testing services to provide clinically-validated, individualized tumor profiles, which may greatly improve the quality of treatment decisions for patients with cancer.
Yes. The company currently has tests that are commercially available for breast and colon cancer patients:
Oncotype DX Breast Cancer Assay
An advanced diagnostic test that analyzes the expression level of specific genes in a woman’s breast cancer tumor sample. It is the only multigene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.
Oncotype DX Breast Cancer Assay for DCIS / Pre-Invasive Breast Cancer
The Oncotype DX Breast Cancer Assay is the first clinically validated, genomic assay which provides DCIS patients with an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma) to help guide treatment decision making in women with ductal carcinoma in situ treated by local excision, with or without adjuvant tamoxifen therapy
Oncotype DX Colon Cancer Assay
An advanced diagnostic test that analyzes the expression level of specific genes in a colon cancer tumor sample. It is the only multigene expression test available that has clinical evidence validating its ability to predict the risk of disease recurrence in patients with newly diagnosed Stage II disease.
For detailed information about these tests, please call: (866) ONCOTYPE or visit www.oncotypedx.com
ASCO® is a registered trademark of the American Society of Clinical Oncology. NCCN® is a registered trademark of the National Comprehensive Cancer Network. ASCO and NCCN do not endorse any product or therapy.
Genomic Health is applying the same technology and clinical rigor used to develop the Oncotype DX breast and colon tests, to other cancers including, prostate, renal cell and lung cancers, as well as melanomas. Visit our Pipeline section for information about products in development, gene expression study results and available tests.
A list of journal articles, presentations and abstracts about our technologies, molecular diagnostic testing and gene expression study results can be found in our Data section.
Visit the Contact Us page for a list of relevant Genomic Health phone numbers and email addresses.
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