Corporate History

1999
  • 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.

 

 
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.
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
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 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
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
March
  • Initial gene expression studies are completed, demonstrating that certain genes 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.
    Press release
July
  • The company hires its first Regional Oncogenomic Liaison (ROL) or sales representative.
August
  • The company finalizes the parameters for its first 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).
    Press release

 

 
2004
January
  • CLIA certifies the Genomic Health clinical laboratory to perform and offer the company’s first test, Oncotype DX®.
  • The first commercial tumor sample arrives at Genomic Health.
  • The first Oncotype DX patient report is generated and shipped from Genomic Health’s lab.
February
  • The company conducts it first advisory board to introduce Oncotype DX 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.
    Press release
December
  • Kaiser Permanente presents results from a study confirming Oncotype DX’s clinical validity in a community setting at SABCS.
    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.
    Press release
    Publication
  • In the days following SABCS, the company receives up to 200 calls per day and the number of assays ordered triples.

 

 
2005
February
  • The College of American Pathologists (CAP) accredits the Genomic Health clinical laboratory.
May
  • An economic analysis modeling the cost-effectiveness of Oncotype DX is published in the American Journal of Managed Care.
    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.
    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.
    Press release
October
  • The Journal of Clinical Oncology (JCO) publishes the Instituto Nazionale Tumori chemotherapy response study.
    Publication
November
  • The company conducts its first conference call as a public company to announce third quarter 2005 financial results.
    Press release
December
  • Genomic Health and the Rocky Mountain Cancer Center present results of a community-based study at SABCS indicating that Oncotype DX can change adjuvant treatment decisions for 25% of patients.
    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.
    Press release

 

 
2006
January
  • Medicare establishes reimbursement for Oncotype DX.
    Press release
May
  • Breast Cancer Research publishes the Kaiser Permanente community-based study of Oncotype DX.
    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.
    Press release
September
November
  • Aetna establishes a national reimbursement contract for Oncotype DX, covering more than 15 million lives.
    Press release
December
  • Genomic Health and NSABP present results at SABCS demonstrating the precision of Oncotype DX in measuring estrogen receptor (ER) status.
    Press release

 

 
2007
January
  • The company moves its colon cancer research program into full clinical development.
    Press release
  • UnitedHealthcare establishes a national reimbursement contract for Oncotype DX.
    Press release
June
  • Genomic Health signs an exclusive agreement with Medical Solutions to distribute Oncotype DX in the United Kingdom.
    Press release
  • Loyola University Health System presents results from an independent prospective multi-center trial that found Oncotype DX impacts treatment decisions for physicians and patients.
    Press release
July
  • The Journal of Oncology Practice publishes the Rocky Mountain Cancer Center’s community-based treatment impact study of Oncotype DX.
    Publication
  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) issues a positive assessment for the use of Oncotype DX to inform decision-making about adjuvant chemotherapy.
    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 assay, for quantifying the hormone receptors estrogen receptor (ER) and progesterone receptor (PR) in breast cancer.
    Press release
October
  • ASCO includes Oncotype DX in its updated guidelines on the use of breast cancer tumor markers.
    Press release
    Guidelines
December
  • The Southwest Oncology Group (SWOG) presents positive results from a study of Oncotype DX in postmenopausal women with node-positive, hormone receptor positive breast cancer at SABCS.
  • Genomic Health announces results from eight Oncotype DX studies presented at SABCS providing additional insights into treatment impact and quantitative single gene expression reporting, as well as new information on node-positive breast cancer.
    Press release

 

 
2008
January
  • The National Comprehensive Cancer Network (NCCN) includes Oncotype DX in its 2008 Breast Cancer Treatment Guidelines.
    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.
    Press release
  • Genomic Health presents results from two studies at the ASCO Gastrointestinal Cancers Symposium identifying genes that could help predict the likelihood of recurrence and chemotherapy benefit for early-stage colon cancer.
    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.
    Publication
  • Genomic Health presents results from two separate studies with collaborators at ASCO identifying genes that could potentially predict benefit from certain targeted therapies in breast and colon cancers.
    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 to measure HER2 status at the ASCO Breast Cancer Symposium.
December
  • Genomic Health presents results from large, European study establishing utility of Oncotype DX in node-negative and node-positive breast cancer patients treated with Aromatase Inhibitors at the 31st annual San Antonio Breast Cancer Symposium (SABCS).
    Press release
  • Genomic Health launches Online Ordering - a new application that allows physicians to order, see status, and receive Oncotype DX results online.

 

 
2009
January
  • Genomic Health announces the initiation of an independent clinical validation study for its 18-gene Oncotype DX colon cancer assay.
    Press Release
  • Genomic Health announces the appointment of Kimberly J. Popovits as Chief Executive Officer.
    Press Release
April
  • Genomic Health Announces Positive Preliminary Results from QUASAR Colon Cancer Validation Study of Oncotype DX Colon Cancer Assay.
    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. 
May
  • Genomic Health announces the presentation of full results from the landmark QUASAR validation study of its Oncotype DX Colon Cancer test at ASCO.
    Press Release
  • Genomic Health presents results from the first study of Oncotype DX Breast Cancer test in male patients at ASCO. 
    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. 
    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. 
    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.
    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 ASCO Breast Cancer Symposium.
    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.
    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.
    Press Release

 

 
2010
January
  • Genomic Health announces worldwide availability of the Oncotype DX Colon Cancer Test..
    Press Release