Corporate History*

1999: A Year of Discovery Results in A New Company that Focuses on Improving the Quality of Treatment Decisions for Patients with Cancer.
1999
January
  • Future Genomic Health® CEO Randy Scott's experience with a close friend who was diagnosed with cancer brings the realization that despite all the research to map and understand the human genome, there is little being done to help patients get the best care based on the molecular make-up of their specific tumor. The frustration of watching a close friend grapple with cancer creates the inspiration for Genomic Health, a company focused on improving the quality of treatment decisions for patients with cancer.
2000: Personalized Breast Cancer Test Studies and Diagnostics for Patients in Need of Cancer Treatment Options Spurs Development of Genomic Health.
2000
August
  • Randy leaves his current company, Incyte, to start Genomic Health, with the goal of developing high-value diagnostics to enable more personalized cancer treatment decisions based on the genomic activity within a patient's individual tumor. In a week's time, he pulls together a rough draft business plan for Genomic Health, targeting ways to improve the quality of cancer treatment decisions.
September
  • Randy takes the plan to his mentor and PhD thesis advisor, Joff Baker, for advice. Joff is enthusiastic and suggests consulting his Genentech colleague, Steve Shak, based on Steve's experience leading the Herceptin clinical program.
  • Randy lines up the first employee, Gene Early (an organizational health consultant), and they begin working from his pool-house to develop a business plan and organization that supports the role of genomic analysis in driving personalized medicine.
October
  • With Gene, Joff and Steve on board, Randy and team recruit patient advocacy expert, Pat Terry, and a founding team is ready to go to work!
November
  • The company completes series A funding, raising $7.9 million from family and friends of the founders.
2001: Genomic Health Makes Great Strides in Proof of Concept.
2001
January
  • The company sets up a lab in an incubator space at the Alameda Naval Air Station.
  • The company completes series B funding with the primary investors Baker-Tisch; Kleiner, Perkins, Caufield & Byers; and Versant, helping to raise an additional $29 million.
March
  • The company completes series C funding, raising an additional $5 million from Incyte.
  • The company has developed an RNA extraction protocol for archived formalin fixed paraffin embedded tissue, and profiles gene expression by reverse transcription polymerase chain reaction (RT/PCR). This same technology is utilized both for product development and for generation of clinical test data in the commercial laboratory.
May
  • The company selects TaqMan RT-PCR as its core expression profile technology.
June
  • The company settles in Redwood City, California.
  • A proof of concept is completed, confirming the company's ability to successfully obtain gene expression analysis profiles from formalin-fixed paraffin-embedded (FPET) tumor tissue.
August
  • The company approaches multiple clinical collaborators, including the NCI cooperative group, National Surgical Adjuvant Breast and Bowel Project (NSABP) about collaborating to transform the way cancer is treated.
November
  • Genomic Health signs an agreement with NSABP to access its archived tissue blocks for the company's clinical studies.
2002: Genomic Health Welcomes New COO; Breast Cancer Diagnostic Testing Efforts Begin Building Steam.
2002
March
  • Kim Popovits joins as President and COO to build the company's commercial operation.
November
  • The management team decides to target early stage, node negative, estrogen-receptor positive breast cancer for its first diagnostic test.
  • The company completes series D funding, raising an additional $9.3 million
2003: Genomic Health Presents Gene Expression Analysis Studies at ASCO and SABCS; Company Continues to Grow.
2003
March
  • Initial gene expression analysis studies are completed, demonstrating that certain genes found in breast cancer tissue can help predict which patients will survive.
May
  • Genomic Health and clinical collaborators present four studies at the American Society of Clinical Oncology (ASCO) Annual Meeting, which examined breast cancer recurrence, response to chemotherapy in breast cancer and a panel of genes associated with response to EGFR inhibitor therapy in lung cancer patients. The following press release provides more details about breast cancer test studies and the ASCO presentation.
    Press Release
July
  • The company hires its first Regional Oncogenomic Liaison (ROL) or sales representative.
August
  • The company finalizes the parameters for its first breast cancer assay and completes lab preparation.
September
  • Genomic Health and NSABP initiate the B14 recurrence validation study.
October
  • B14 validation study is completed and the results meet defined end points.
November
  • The company successfully completes its CLIA (Clinical Laboratory Improvement Amendments) lab inspection.
December
  • Genomic Health and NSABP present positive results from the B14 recurrence validation study at the San Antonio Breast Cancer Symposium (SABCS).The following press release details Genomic Health's breast cancer test presentation at SABCS.
    Press Release
2004: A Year of Introduction, Recognition and Results Impacts Patients in Need of Improved Cancer Treatment Decisions.
2004
January
  • CLIA certifies the Genomic Health clinical laboratory to perform and offer the company's first breast cancer assay, Oncotype DX®.
  • The first commercial tumor sample arrives at Genomic Health.
  • The first Oncotype DX Breast Cancer Assay patient report is generated and shipped from Genomic Health's lab.
February
  • The company conducts it first advisory board to introduce the Oncotype DX breast cancer test to the physician community.
June
  • Genomic Health and Instituto Nazionale Tumori announce preliminary results from an initial chemotherapy response study at the annual ASCO meeting; ASCO selects the B14 validation study for its "Best of Oncology" special session.The following press release provides details about the breast cancer test.
    Press Release
December
  • Kaiser Permanente presents results from a study confirming Oncotype DX breast cancer assay's clinical validity in a community setting at SABCS. The following press release provides more information about the test for breast cancer.
    Press Release
  • Genomic Health and NSABP present positive results from the B20 chemotherapy benefit study at SABCS; the New England Journal of Medicine publishes the B14 recurrence validation study online as an "early release" to coincide with SABCS data presentations about the test for breast cancer. The following press release provides more information about the breast cancer assay.
    Press Release
    Publication
  • In the days following SABCS, the company receives up to 200 calls per day and the number of breast cancer assays ordered triples.
2005: Company Announces Initial Public Offering.
2005
February
  • The College of American Pathologists (CAP) accredits the Genomic Health clinical laboratory.
May
  • An economic analysis modeling the cost-effectiveness of the Oncotype DX breast cancer assay is published in the American Journal of Managed Care. The following press release provides more details about the breast cancer test.
    Press Release
    Publication 
  • Genomic Health presents multiple studies at ASCO that support Oncotype DX's ability to predict chemotherapy benefit and capture prognosis and response to tamoxifen; ASCO selects the B20 chemotherapy response study for its "Best of Oncology" special session. The following press release provides more information about the breast cancer test selected for presentation by ASCO.
    Press Release
September
  • Genomic Health goes public, raising more than $60 million through an initial public offering of 5,016,722 shares of Common Stock valued at $12.00 per share.The following press release provides more information about the initial public offering.
    Press Release
October
  • The Journal of Clinical Oncology (JCO) publishes the Instituto Nazionale Tumori chemotherapy response study of the breast cancer test. The article in the Journal of Clinical Oncology details the study's findings.
    Publication
November
  • The company conducts its first conference call as a public company to announce third quarter 2005 financial results. The following press release provides more details about advancing strategy to provide critical information that enables more informed cancer treatment decisions.
    Press Release
December
  • Genomic Health and the Rocky Mountain Cancer Center present results of a community-based study at SABCS indicating that the Oncotype DX breast cancer assay can change adjuvant treatment decisions for 25% of patients. The following press release provides more information about the breast cancer test.
    Press Release
  • Genomic Health presents two studies at SABCS demonstrating Oncotype DX's ability to quantify risk for local and regional recurrence, and provide robust results on small tumor specimens. The following press release provides details about the breast cancer assay.
    Press Release
2006: Medicare Establishes Reimbursement for the Oncotype DX Breast Cancer Assay.
2006
January
  • Medicare establishes reimbursement for Oncotype DX breast cancer assay. The following press release provides more information about the reimbursement policy for the breast cancer test.
    Press Release
May
  • The Journal of Clinical Oncology (JCO) publishes the B20 chemotherapy benefit study online as an "early release" to coincide with the launch of NCI's landmark clinical trial, TAILORx. The following press release provides details about the study published in JCO, which confirms the Oncotype DX test for breast cancer predicts the likelihood of response to chemotherapy in a large portion of women with early-stage breast cancer. The breast cancer assay is discussed in further detail in the JCO publication.
    Press Release
    Publication
  • Breast Cancer Research publishes the Kaiser Permanente community-based study of Oncotype DX. The following press release provides information about the publication of the landmark Kaiser Permanente study demonstrating the Oncotype DX breast cancer assay helps predict likelihood of survival in early-stage breast cancer. The publication provides full detail of the Oncotype DX breast cancer assay study results.
    Press Release
    Publication
June
  • Genomic Health and NSABP present results from the first colon cancer study at ASCO demonstrating a correlation between gene expression and disease recurrence, prompting additional studies for the development of a colon cancer test. The following press release provides information about the study's findings, which indicate that an Oncotype DX test service may improve treatment decisions for patients seeking treatment for colon cancer.
    Press Release
September
  • The U.S. Food and Drug Administration (FDA) issues draft guidance on the potential regulation for In Vitro Diagnostic Multivariate Index Assays, or IVDMIAs. The following press release provides more information.
    Press Release
November
  • Aetna establishes a national reimbursement contract for the Oncotype DX breast cancer assay, covering more than 15 million lives. The following press release provides details about Aetna's contract for breast cancer test services.
    Press Release
December
  • Genomic Health and NSABP present results at SABCS demonstrating the precision of the Oncotype DX breast cancer assay in measuring estrogen receptor (ER) status. The following press release provides information about the study results.
    Press Release
2007: Breast Cancer Test Goes Global; Breast Cancer Test Services Provided Worldwide.
2007
January
  • The company moves its colon cancer assay research program into full clinical development. The following press release provides details about how patients seeking colon cancer treatment may benefit from improved treatment decisions.
    Press Release
  • UnitedHealthcare establishes a national reimbursement contract for Oncotype DX breast cancer test services. The following press release provides information about the insurance company contract for breast cancer test.
    Press Release
June
  • Genomic Health signs an exclusive agreement with Medical Solutions to distribute the Oncotype DX breast cancer test in the United Kingdom. The following press release provides full details about the agreement to distribute the test in the UK.
    Press Release
  • Loyola University Health System presents results from an independent prospective multi-center trial that found the Oncotype DX test for breast cancer impacts treatment decisions for physicians and patients. The following press release provides details about the study.
    Press Release
  • Genomic Health presents positive results at ASCO from its first study investigating the Oncotype DX breast cancer assay in node-positive breast cancer patients. The following press release provides more information about the breast cancer test results.
    Press Release
July
  • The Journal of Oncology Practice publishes the Rocky Mountain Cancer Center's community-based treatment impact study of the Oncotype DX breast cancer assay. The publication provides extensive details about the breast cancer test study. 
    Publication
  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) issues a positive assessment for the use of the Oncotype DX breast cancer assay to inform decision-making about adjuvant chemotherapy treatments for breast cancer. The following press release provides additional details about the assessment.
    Press Release
September
  • Genomic Health presents results from three studies at the ASCO Breast Cancer Symposium that support the use of quantitative real-time polymerase chain reaction (RT-PCR), as performed in the Oncotype DX breast cancer assay, for quantifying the hormone receptors estrogen receptor (ER) and progesterone receptor (PR) in breast cancer. The following press release provides more information about the breast cancer test studies.
    Press Release
October
  • ASCO includes the Oncotype DX breast cancer assay in its updated guidelines on the use of breast cancer tumor markers. The following press release provides more information about ASCO's breast cancer guidelines. The guidelines published by ASCO provide more detail about the usage of tumor markers in the treatments of breast cancer.
    Press Release
    Guidelines
December
  • The Southwest Oncology Group (SWOG) presents positive results from a study of Oncotype DX breast cancer tests in postmenopausal women with node-positive, hormone receptor positive breast cancer at SABCS.
  • Genomic Health announces results from eight Oncotype DX breast cancer test studies presented at SABCS providing additional insights into the impact on treatment options for patients seeking treatments for breast cancer and quantitative single gene expression reporting, as well as new information on node-positive breast cancer. The breast cancer assay studies presented at SABCS are detailed in the press release.
    Press Release
2008: Company Continues to Move Forward, Begins Offering Oncotype DX Breast Cancer Test Ordering and Results Online.
2008
January
  • The National Comprehensive Cancer Network (NCCN) includes Oncotype DX in its 2008 Breast Cancer Treatment Guidelines. Learn more about the breast cancer assay in a press release. The NCCN Treatments for Breast Cancer Guidelines are available online.
    Press Release
    Guidelines
  • Genomic Health and Pfizer initiate a collaboration to develop a prognostic test to estimate the risk of recurrence for patients with non-metastatic renal cell carcinoma. The following press release provides more information.
    Press Release
  • Genomic Health presents results from two studies at the ASCO Gastrointestinal Cancers Symposium identifying genes that could help predict the likelihood of colon cancer recurrence and chemotherapy benefit for early-stage colon cancer. The following press release provides more information about the likelihood of colon cancer recurrence and potential chemotherapy benefits.
    Press Release
February
  • The company begins including quantitative ER and PR scores on all Oncotype DX patient reports.
May
  • The Journal of Clinical Oncology published results of a study demonstrating the validity of Oncotype DX in measuring quantitative gene expression for ER and PR status, indicating that quantitative RT-PCR, as performed in the Oncotype DX breast cancer assay, is a reliable method for determining hormone receptor status in breast cancer. The publication provides more information about the test for breast cancer. 
    Publication
  • Genomic Health presents results from two separate studies with collaborators at ASCO identifying genes that could potentially predict benefit from certain targeted therapies and treatments for breast and colon cancers. The following press release offers more details about the predicted benefits for patients seeking treatment of colon cancer and breast cancer.
    Press Release
September
  • The Journal of Clinical Oncology published results of a study comparing Oncotype DX to Adjuvant! Online computer-based algorithm.
  • Genomic Health announces results of two studies supporting the use of Oncotype DX breast cancer tests to measure HER2 status at the ASCO Breast Cancer Symposium.
December
  • Genomic Health presents results from large, European study establishing utility of Oncotype DX breast cancer assay in node-negative and node-positive breast cancer patients treated with Aromatase Inhibitors at the 31st annual San Antonio Breast Cancer Symposium (SABCS). The following press release provides more information about the European breast cancer test study.
    Press Release
  • Genomic Health launches Online Ordering - a new application that allows physicians to order, see status, and receive Oncotype DX breast cancer test results online.
2009: Company Makes Great Strides in Colon Cancer Assay Validation Studies.
2009
January
  • Genomic Health announces the initiation of an independent clinical validation study for its 18-gene Oncotype DX Colon Cancer Assay. The following press release offers more details about the study's findings related to the colon cancer assay.
    Press Release
  • Genomic Health announces the appointment of Kimberly J. Popovits as Chief Executive Officer. The following press release provides more information about the appointment.
    Press Release
April
  • Genomic Health Announces Positive Preliminary Results from QUASAR Colon Cancer Validation Study of Oncotype DX colon cancer assay. The following press release offers more information about how the validation study may predict the likelihood of recurrence for stage II colon cancer patients following surgery.
    Press Release
  • Genomic Health announces positive results from its first Japanese study, confirming the Oncotype DX Recurrence Score® accurately predicts the likelihood of breast cancer recurrence in a specific ethnic population. The following press release offers more information about the breast cancer assay study.
    Press Release
May
  • Genomic Health announces the presentation of full results from the landmark QUASAR validation study of its Oncotype DX® colon cancer assay test at ASCO. The following press release provides more detail about the colon cancer assay test study.
    Press Release
  • Genomic Health presents results from the first study of Oncotype DX® Breast Cancer test in male patients at ASCO. The following press release provides more information about the company's breast cancer tests for men.
    Press Release
  • Genomic Health announces that the Oncotype DX Breast Cancer test has helped guide individualized treatment decisions for more than 100,000-breast cancer patients worldwide. The following press release provides more information about the breast cancer test impacts.
    Press Release
June
  • Genomic Health reports favorable commentary on the value of multigene tests from the St. Gallen expert consensus meeting on the primary treatment of early breast cancer. The following press release provides more details about the impact of the tests on diagnostics for patients in need of treatments for breast cancer.
    Press Release
September
  • Genomic Health presents data confirming the consistent distribution of the Oncotype DX Recurrence Score across European, Middle Eastern and U.S. patient populations, at the joint ESMO/ECCO Multidisciplinary Congress. The following press release offers more information about the breast cancer tests.
    Press Release
October
  • Genomic Health presents data confirming manual microdissection of biopsy cavities is essential for accurate recurrence risk assessment in early-stage breast cancer patients, at the American Society of Clinical Oncologists (ASCO) Breast Cancer Symposium. The following press release provides more information about the critical role of the Onctotype DX breast cancer test.
    Press Release
December
  • Genomic Health presents five new studies at the San Antonio Breast Cancer Symposium (SABCS), reinforcing clinical utility of Oncotype DX in multiple breast cancer populations. The following press release explains how the test for breast cancer may impact patients' treatment decisions.
    Press Release
  • The Lancet Oncology publishes a study of Oncotype DX node-positive breast cancer that identifies patients who do not appear to benefit from chemotherapy. The following press release provides more information about how the Oncotype DX breast cancer test can help predict chemotherapy benefit in breast cancer patients with node-positive disease.
    Press Release
2010: Genomic Health Begins New Decade by Making Colon Cancer Assay Test Available Worldwide.
2010
January
  • Genomic Health announces worldwide availability of the Oncotype DX colon cancer assay test. The following press release provides more information about the impacts of the test on the assessment of risk of colon cancer recurrence.
    Press Release
March
  • Genomic Health signs an exclusive agreement with Palex Medical S.A. to distribute the Oncotype DX test in Spain and Portugal. The following press release provides additional information about the Genomic Health Palex partnership.
    Press Release
  • Genomic Health presents results demonstrating the successful whole genome expression and mutation analysis from formalin fixed, paraffin-embedded tumor samples, at the 11th Annual Advances in Genome Biology and Technology (AGBT) meeting in Marco Island, Florida. The following press release provides additional information about the whole genome expression and mutation analysis.
    Press Release
  • Genomic Health presents results at the 27th Annual Miami Breast Cancer Conference demonstrating that ribonucleic acid (RNA) extraction and reverse transcription polymerase chain reaction (RT-PCR) technology can be successfully performed to assess gene expression profiles from formalin fixed paraffin embedded ductal carcinoma in situ (DCIS) patient samples. These findings indicate that it is feasible to obtain Oncotype DX Recurrence Score® results in DCIS patients.
  • The Journal of Clinical Oncology (JCO) publishes positive results from a large international study which demonstrated that the Oncotype DX breast cancer Recurrence Score result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive, postmenopausal breast cancer patients who are treated with either anastrozole or tamoxifen. The following press release provides more information about the JCO publication.
    Press Release
June
  • Genomic Health announces the presentation of six new studies including four oral presentations in breast, colon and renal cancers at American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The following press release provides more detail about the six studies, including results from a collaboration with Pfizer Oncology for assessing prognosis for early-stage renal cell carcinoma.
    Press Release
October
  • Utilizing social media tools such as facebook, twitter, and YouTube, Genomic Health launches "Pass It On... Until Every Woman Knows", an online awareness campaign designed to educate people about personalized breast cancer treatment, and Oncotype DX. To learn more about "Pass It On... Until Every Woman Knows," visit: www.untileverywomanknows.com
December
  • Genomic Health presents multiple studies highlighting the important role of the Oncotype DX breast cancer test in treating the underlying biology of early-stage breast cancer at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), including a meta-analysis of seven studies reinforcing the significance of the Recurrence Score in changing treatment decisions. The following press release provides information about the study results.
    Press Release
2011: Genomic Health Accelerates their Oncotype DX Prostate Program.
2011
January
  • Genomic Health presents at the 2011 J.P. Morgan Healthcare Conference in San Francisco, and announces the acceleration of the company's prostate cancer program. The following press release provides information about the company's prostate cancer program.
    Press Release
  • Genomic Health announces multiple colon cancer studies at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, including data that supports the use of the Oncotype DX colon cancer test in stage II patients, and company's plan to launch mismatch repair (MMR) IHC testing in 2011. The following press release provides information about the study results. To learn more about Genomic Health's pipeline, visit the Pipeline page.
    Press Release
February
  • Genomic Health announced results from a biomarker discovery program utilizing next-generation sequencing (NGS) to compare normal and tumor breast tissue, at the 12th Annual Advances in Genome Biology and Technology Meeting. Genomic Health scientists successfully surveyed expression of the whole human transcriptome using next-generation DNA sequencing technology developed by Illumina, Inc., to test hypotheses for biomarker discovery in archived tumor and normal breast tissue samples. In addition, an algorithm was developed to detect and quantify transcripts from non-coding regions of the genome and through this process more than 1,000 differentially expressed non-coding sequences were identified.
    Press Release
  • Genomic Health presented multiple prostate cancer studies including complete results from a gene identification study, suggesting that quantitative gene expression will be clinically useful in prostate cancer treatment, at the 2011 American Society of Clinical Oncology® (ASCO®) Genitourinary (GU) conference. Further, the company is on track to finalize analytical methods this year (2011), for a 2012 prostate cancer clinical validation study.
    Press Release
March
  • Fight Colorectal Cancer and Genomic Health launched a unique online resource for colon cancer patients called "My Colon Cancer Coach" visit the website www.MyColonCancerCoach.org to learn more.
    Press Release
  • Genomic Health presented nine studies from seven countries at the 12th Annual St. Gallen International Breast Cancer Conference, showing that when used, the Oncotype DX® Breast Cancer Test resulted in chemotherapy reduction and overall cost effectiveness.
    Press Release
April
  • Genomic Health announces Launch of NCI RxPONDER Trial utilizing Oncotype DX® in women with Node-positive breast cancer.
    Press Release
May
  • Genomic Health presents ten studies covering breast, colon and prostate cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting.
    Press Release
June
  • Genomic Health announces positive preliminary results of Oncotype DX® study in DCIS breast and plans to submit for data for presentation at the 2011 San Antonio Breast Cancer Symposium (SABCS). 
    Press Release
July
  • Genomic Health announces that the Oncotype DX breast cancer test is included in the St. Gallen International Breast Cancer Expert Panel Guideline, as a predictor of chemotherapy benefit for early-stage breast cancer patients. 
    Press Release
September
  • Genomic Health announces presentation of five studies in breast and colon cancers at the 2011 European Multidisciplinary Cancer Congress.
    Press Release
  • Genomic Health announces Medicare coverage for Oncotype DX® Colon Cancer Test.
    Press Release
October
  • Genomic Health launches smartphone application to improve access to important treatment information for newly diagnosed breast and colon cancer patients.
    Press Release
November
  • Genomic Health announces publication of QUASAR study confirming Oncotype DX® predicts individualized recurrence risk for stage II colon cancer patients 
    Press Release
December
  • Genomic Health announces positive results of first clinical outcomes study for biomarker discovery using Next Generation Sequencing at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.
    Press Release 
  • Genomic Health announces results from fourteen studies emphasizing belief of physicians around the world in the value of Oncotype DX.
    Press Release 
  • Genomic Health launches the Oncotype DX® Breast Cancer test for DCIS patients – the first clinically validated genomic assay to provide an individualized prediction of the 10-year risk of local recurrence to help guide treatment decision-making in patients with ductal carcinoma in situ treated by local excision, with or without tamoxifen. The DCIS Score is obtained by performing the Oncotype DX Breast Cancer test using a pre-specified DCIS algorithm optimized to predict recurrence regardless of whether adjuvant tamoxifen therapy was given. Click here to learn more.
  • Genomic Health began providing mismatch repair (MMR) testing for recurrence risk that allows physicians to identify the approximately 15% of stage II colon cancer patients with MMR-deficient tumors, who have low recurrence risk and thus may be more appropriately considered for observation following surgery. Click here to learn more about MMR testing at Genomic Health.
2012: Genomic Health Accelerates Their Next Generation Sequencing Program.
2012
January
  • Genomic Health announces initiation of a clinical validation study of their prostate cancer test; & the acceleration of the company's Next Generation Sequencing program.
  • The prostate cancer test validation study, being performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), is designed to determine if a multi-gene test can help distinguish aggressive disease requiring surgery from less aggressive disease that may undergo active surveillance in patients with early-stage prostate cancer. Complete results are expected to be presented at the end of this year or early next year, and if positive, are expected to support the launch of the Oncotype DX® prostate cancer test in 2013.
  • The company also announced that it is accelerating its Next Generation Sequencing (NGS) program by moving it into clinical development studies that will examine both RNA-Seq expression and mutation analysis. This decision comes after the company successfully conducted the first clinical outcomes study for biomarker discovery using NGS for whole transcriptome profiling of archival FFPE tumor specimens. Results of this study were presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium in December. In addition, informatics infrastructure investments to support a cloud-based system for storage and analysis of large genomic data sets are underway. The NGS technology allows Genomic Health scientists to assay the entire genome simultaneously to discover regions of the genome whose expression is associated with clinical outcomes and treatment response.
    Press Release
  • Genomic Health presents new data at the 2012 Gastrointestinal Cancers Symposium, which demonstrates a 29% change in treatment recommendations in stage II colon cancer patients, reinforcing clinical benefit and supporting the wider adoption of the Oncotype DX Colon Cancer test.
    Press Release
February
  • Genomic Health presents results from a large clinical study in prostate cancer evaluating the relationship of microRNAs, a novel class of biomarkers, to clinical outcomes for patients with early-stage prostate cancer. The data, presented at the 2012 Genitourinary (GU) Cancers Symposium, contribute to a greater understanding of prostate cancer biology by assessing the ability of specific microRNAs and genes to predict aggressive disease as part of the company's prostate cancer research and development program.
    Press Release
March
  • Genomic Health announces presentation of three Oncotype DX studies at the 8th European Breast Cancer Conference. Results from these studies reconfirm the cost-effectiveness of the Oncotype DX breast cancer test and emphasize the important role it can play in guiding treatment decisions.
    Press Release
September
  • Genomic Health announces positive results from a large clinical validation study of its biopsy-based prostate cancer test. The study, performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), met its primary endpoint by demonstrating that the multi-gene Oncotype DX Genomic Prostate Score (GPS), assessed in prostate needle biopsy tumor tissue, has been prospectively validated as a predictor of adverse pathology for patients with early-stage prostate cancer. UCSF and Genomic Health plan to submit complete data from this study for presentation at the 2013 ASCO Genitourinary Cancers Symposium in February. Based on these results, Genomic Health is completing the necessary work in its Clinical Reference Laboratory to make the Oncotype DX prostate cancer test available to physicians and patients in the first half of 2013.
    Press Release
2013: Genomic Health Launches The Oncotype DX Prostate Cancer Test.
2013
January
  • Genomic Health announces results from three studies of the Oncotype DX Colon Cancer test at the 2013 Gastrointestinal (GI) Cancers Symposium, including new data demonstrating that Recurrence Score(RS) results changed treatment recommendations in 45 percent of the enrolled stage II colon cancer patients. Presentations also include positive findings from a second health economics analysis suggesting that use of the test may result in a significant reduction in direct medical costs and improve patient well-being.
    Press Release
March
  • Genomic Health announces positive results of a large study that demonstrates the Oncotype DX Recurrence Score result to be a robust predictor of loco-regional recurrence (LRR) in node-positive (N+), estrogen receptor (ER) positive patients treated with adjuvant hormonal therapy and chemotherapy. This study, titled "Prognostic impact of the 21-gene Recurrence Score (RS) on loco-regional recurrence (LRR) of node-positive, ER-positive breast cancer patients (pts) treated with adjuvant chemotherapy: Results from NSABP B-28" was presented at the 2013 Society of Surgical Oncology Annual Cancer Symposium in National Harbor, Maryland.
    Press Release
April
  • Genomic Health announces that the Journal of Clinical Oncology (JCO) published positive results from the large CALGB 9581 clinical validation study of the Oncotype DX colon cancer test in stage II colon cancer patients. The findings provide further confirmation that the Oncotype DX Recurrence Score (RS) results improve the ability to differentiate high recurrence risk disease from low, beyond conventional factors such as T-stage, mismatch repair (MMR) status, nodes examined, grade and lymphovascular invasion.
    Press Release  
May
  • Genomic Health launches the Oncotype DX prostate cancer test. Developed in collaboration with UCSF and Cleveland Clinic, the Oncotype DX prostate cancer test (Genomic Prostate Score) is a biopsy-based genomic test that, when combined with other measures, can be used to predict the aggressiveness of a man’s prostate cancer, helping him and his doctor decide what treatment is right for him. Learn more about the Oncotype DX prostate cancer test.
  • Genomic Health and the ECOG-ACRIN Cancer Research Group jointly announce that the Journal of the National Cancer Institute (JNCI) published positive results from their clinical validation study of the Oncotype DX DCIS Score in patients with ductal carcinoma in situ (DCIS), an early or pre-invasive form of breast cancer. The prospective study, designed and conducted jointly by Genomic Health and ECOG-ACRIN, established that the Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the 10-year risk of local recurrence, defined as recurrence of DCIS or invasive breast cancer in the same breast, a finding that will help to guide radiation treatment decision-making for women with DCIS who are treated by local excision.
    Multi-Media Press Release

Learn more about Genomic Health's product development activities.  Contact Genomic Health for more information.

* 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.