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Foundation Medicine, Inc.
Headquarters
Cambridge, Massachusetts
,
United States
Key people
  • Troy Cox (CEO)
  • Jason Ryan (CFO)
  • Tom Civik (CCO)
  • Vincent Miller, M.D. (CMO)
  • Melanie Nallicheri (CBO)
ProductsFoundationOne FoundationOneHeme FoundationACT FoundationOne CDx Foundation Insights FoundationSmartTrials
OwnersRoche
Number of employees
501-1,000 (July 2018)[1]
WebsiteOfficial website

Foundation Medicine, Inc. is a public American company based in Cambridge, Massachusetts which develops, manufactures, and sells genomic profiling assays for solid tumors, hematologic malignancies, and sarcomas.[2] The company's tests are based on next-generation sequencing technology.[3] The company also provides data and related services to pharmaceutical companies and researchers.[1]

In addition to its Cambridge headquarters, the company has laboratory facilities in Penzberg, Germany and Morrisville, North Carolina.[4]

Products and offerings

Foundation Medicine’s products support personalized medicine and precision medicine and include genomic tests for solid tumors and blood-based cancers and sarcomas, as well as data services that are designed to help pharmaceutical companies develop and test new personalized medicines.[1]

The company’s assays are used by clinicians and pharmaceutical companies to analyze cancer biomarkers in patient tumor samples.[5][6] Test results include an analysis of genomic alterations relevant to available cancer therapies, other genomic markers that may inform response to cancer immunotherapy,[7][5] and potential targeted therapies[8] and/or clinical trial eligibility.[9][10][11]

In the clinical setting, the tests are designed to help doctors match patients to these various treatment pathways.[12]

Foundation Medicine’s technology and data offerings are intended to support biopharma clinical research and aimed at improving patient outcomes by aiding drug development and clinical trial design through molecular data insights.[13][14]

Clinical Products

  • FoundationOne is a comprehensive genomic profiling (CGP) assay for solid tumors.[15]
  • FoundationOneHeme is a CGP assay for hematologic cancers and sarcomas that employs both DNA and RNA sequencing.[16] The test sequences more than 400 cancer-related genes and, using RNA-seq, can assess gene fusions in 265 genes that are common mutations among sarcomas and hematologic malignancies.[16][15]
  • FoundationACT is a blood-based circulating tumor DNA (ctDNA) assay for solid tumors that can detect cancer-driving alterations in more than 60 genes.[12]
  • FoundationOne CDx is a CGP assay for all solid tumors that incorporates multiple companion diagnostics.[11] It includes companion diagnostic indications for five tumor types: ovarian, lung, breast, colorectal, and melanoma that can help match patients to 17 targeted therapies.[8]

Technology and data services

  • The company’s FoundationCore database contains more than 200,000 genomic profiles[17][18] sourced from the results of the company’s assays, as well as data on over 150 cancer subtypes.[11][14] The data are used by the company to provide treatment information to clinicians and in partnerships with healthcare technology and pharmaceutical companies for use in research and clinical development.[6][1]

History

Foundation Medicine was founded in Cambridge, Massachusetts.[6] The company was conceived after Broad Institute researchers Levi Garraway, M.D., Ph.D. and Matthew Meyerson, M.D., Ph.D. published a 2007 paper detailing an efficient method for large-panel testing of 238 DNA mutations.[6] Founding academic advisors from the Broad Institute, Dana–Farber Cancer Institute, Harvard Medical School, and MIT, including Garraway, Meyerson, Eric Lander, Ph.D. and Todd Golub, M.D, laid the groundwork for the company over two years.[19]

Foundation Medicine launched in 2010 with a $25 million Series A financing led by Third Rock Ventures.[19] Other early investors included Google Ventures, Kleiner Perkins Caufield & Byers, and Bill Gates.[9] Alexis Borisy served as the founding chief executive officer of the company.[19] He was succeeded by Michael Pellini in 2011.[20]

The company released its first commercial assay, or test, called FoundationOne in 2012.[6] Unlike first-generation genomic profiles of tumors, FoundationOne had the ability to test for genetic mutations in approximately 240 genes at once.[9][16] Results from the test’s validation were published in ‘’Nature Biotechnology’’ in 2013.[21]

The company also began partnering with pharmaceutical companies to analyze patient samples.[6] The first such program was piloted with Novartis in 2011,[19] and by 2018, the company had more than 30 partnerships.[22]

Foundation Medicine launched its second test, a hematological biomarker assay called FoundationOneHeme, in 2013.[16] The company collaborated with Memorial Sloan-Kettering Cancer Center researchers on the test, who validated the assay on approximately 400 patient samples[16] and published the findings in ‘’Blood’’ in 2016.[23]

The company held its initial public offering in August 2013.[15] The following year, Priority Health in Michigan became the first healthcare plan in the United States to cover the company’s tests.[24]

In 2015, Foundation Medicine reached a US$1.2 billion deal with Swiss holding company Roche that gave Roche a majority stake in the company.[20][10] In June, 2018, Roche announced it would acquire the outstanding shares of Foundation Medicine for $2.4 billion ($137 per share).[25]

The company established the Precision Medicine Exchange Consortium (PMEC) in 2015, a data-sharing program designed to facilitate the exchange of de-identified and HIPAA compliant genomic information and treatment data for advanced research in the area of precision oncology.[14] At launch, seven institutions were members of the exchange.[14]

In 2016, Foundation Medicine released 18,000 anonymized genomic profiles of adult cancers from its FoundationCore database to the National Cancer Institute’s (NCI) Genomic Data Commons (GDC) portal in an effort to facilitate and accelerate research in precision medicine as part of the National Cancer Moonshot and Precision Medicine Initiative created by the Obama administration.[26] The contribution was the largest public data release to the NCI[27] and more than doubled the size of the GDC database.[28]

The company introduced two products in 2016—FoundationACT, a liquid biopsy assay for solid tumors, and FoundationFocus CDx BRCA, a companion diagnostic test for Rubraca (rucaparib) in ovarian cancer that was approved by the Food and Drug Administration (FDA) in December of that year.[12]

In January 2017, Foundation Medicine’s Board of Directors appointed Troy Cox as chief executive officer to succeed Michael Pellini, who became chairman of the board.[20]

In December 2017, the company’s assay FoundationOne CDx received approval from the FDA and a preliminary National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS).[29] FoundationOne CDx was the second product to be approved under the parallel review program run by the FDA and CMS.[11]

TMB and bTMB research

FoundationOne assesses a large number of genes and sequences approximately 1.1 megabases (Mb) of the coding genome, allowing it to accurately assess TMB, which the company has used both in reporting and other research applications.[12][30]

In 2017, a summary of Foundation Medicine’s TMB results in over 88,150 clinical samples was presented at the American Association for Cancer Research (AACR). The update noted high TMB in several cancers, including advanced skin, lung, and bladder cancer.[7] The company also presented evidence at the 2017 European Society for Medical Oncology (ESMO) meeting that immunotherapy response can be predicted using an assay the company developed measuring tumor mutational burden from a blood, rather than tissue, sample (bTMB), rather than tissue, in certain indications. As of 2018, the test is being used in a Roche clinical trial (Blood First Assay Screening Trial) for immunotherapy Tecentriq.[31]

See also

References

  1. ^ a b c d "Company Overview of Foundation Medicine, Inc". Bloomberg News. Retrieved 1 July 2018.
  2. ^ Staff (15 January 2015). "Cambridge startup soars on Roche stake". Business. The Boston Globe.
  3. ^ Staff (9 January 2015). "Foundation Medicine on the Added Value of NGS Cancer Tests". Clinical Informatics News. Needham, Massachusetts, United States: Cambridge Healthtech Institute.
  4. ^ Julia Karow (August 3, 2016). "Foundation Medicine Pursuing Multiple Strategies to Expand Reimbursement for Clinical Tests". Genome Web. Retrieved 18 January 2018.
  5. ^ a b Susan Young Rojahn (12 November 2013). "Genomics Could Blow Up the Clinical Trial". MIT Technology Review. Retrieved 18 June 2018.
  6. ^ a b c d e f Adrienne Burke (February 21, 2012). "Foundation Medicine: Personalizing Cancer Drugs". MIT Technology Review. Retrieved 18 January 2018.
  7. ^ a b Ken Garber (27 June 2018). "Mutation-counting blood test could predict if cutting-edge immunotherapies can beat a cancer". Science Magazine. Retrieved 18 July 2018.
  8. ^ a b "Pfizer, Foundation Medicine Developing Companion Diagnostics for Cancer Drugs". Genome Web. January 16, 2018. Retrieved 18 January 2018.
  9. ^ a b c Emily Mullin (January 22, 2013). "Bill Gates helps genomic tests startup lay firm foundation". FierceBiotech. Retrieved 18 January 2018.
  10. ^ a b Ron Winslow (January 12, 2015). "Roche Holding to Pay $1.03 Billion for Diagnostics-Firm Stake". The Wall Street Journal. Retrieved 18 January 2018.
  11. ^ a b c d Alex Philippidis (January 16, 2018). "Pfizer Joins Foundation Medicine to Develop Cancer CDx". GEN. Retrieved 18 January 2018.
  12. ^ a b c d Ariela Katz. "Biotech Executive Offers Glimpse of Testing Future". OncLive. Retrieved 18 January 2018.
  13. ^ Stephanie Baum (2 December 2014). "Big data meets genomic profiling to improve clinical trials for cancer drugs". MedCityNews. Retrieved 18 June 2018.
  14. ^ a b c d Abigail Ballou (December 27, 2016). "Improving Patient Outcomes Through Data Exchange". MedTech Boston. Retrieved 18 January 2018.
  15. ^ a b c Don Seiffert (December 4, 2014). "Foundation Medicine still growing a year after launching blood-cancer test". Boston Business Journal. Retrieved 18 January 2018.
  16. ^ a b c d e Julia Karow (December 11, 2013). "LabCorp Steps into NGS-based Oncology Market as Foundation Medicine Adds Hematologic Cancer Test". Genome Web. Retrieved 18 January 2018.
  17. ^ Shanthi Rexaline (February 15, 2018). "Foundation Medicine Set For 'Material Upside,' Cowen Says In Bullish Initiation". Yahoo! News. Retrieved 29 June 2018.
  18. ^ "Foundation Medicine : Reports Preliminary 2017 Results". 4-Traders. January 18, 2018. Retrieved 29 January 2018.
  19. ^ a b c d Julia Karow (April 13, 2011). "Foundation Medicine Developing Targeted Sequencing Test for 'Clinically Actionable' Cancer Genes". Genome Web. Retrieved 18 January 2018.
  20. ^ a b c Max Stendahl (January 6, 2017). "Cambridge's Foundation Medicine gets new CEO in leadership shuffle". Boston Business Journal. Retrieved 18 January 2018.
  21. ^ Frampton, Garrett M; Fichtenholtz, Alex; Otto, Geoff A; et al. (2013). "Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing". Nature Biotechnology. 31 (11): 1023. doi:10.1038/nbt.2696. ISSN 1087-0156. {{cite journal}}: Cite has empty unknown parameter: |1= (help); Explicit use of et al. in: |first3= (help)
  22. ^ Julia Karrow (8 March 2018). "Foundation Medicine to Grow Clinical Testing, Pharma Business in 2018". GenomeWeb. Retrieved 18 June 2018.
  23. ^ He, J.; Abdel-Wahab, O.; Nahas, M. K.; et al. (2016). "Integrated genomic DNA/RNA profiling of hematologic malignancies in the clinical setting". Blood. 127 (24): 3009. doi:10.1182/blood-2015-08-664649. ISSN 0006-4971. {{cite journal}}: Explicit use of et al. in: |first3= (help)
  24. ^ Don Seiffert (November 20, 2014). "Foundation Medicine's shares gain on flurry of good news ahead of earnings call". Boston Business Journal. Retrieved 18 January 2018.
  25. ^ Shields, Michael; Hirschler, Ben (19 June 2018). "Roche pays $2.4 billion for rest of cancer expert Foundation Medicine". Reuters. {{cite journal}}: Unknown parameter |name-list-format= ignored (|name-list-style= suggested) (help)
  26. ^ Constance Gustke (July 6, 2017). "Joe Biden's moonshot to crack the code on cancer, one of the biggest killers in America". CNBC. Retrieved 18 January 2018.
  27. ^ "Industry Playbook". AACC. September 1, 2016. Retrieved 18 January 2018.
  28. ^ Don Seiffert (June 29, 2016). "Cambridge diagnostic firm to double size of 'Moonshot' cancer database". Boston Business Journal. Retrieved 18 January 2018.
  29. ^ "JPM Healthcare Day 1: Genomic Health, Foundation Medicine, Qiagen, Myriad, and Guardant". 360Dx. January 9, 2018. Retrieved 18 January 2018.
  30. ^ Chalmers, Zachary R.; Connelly, Caitlin F.; Fabrizio, David; et al. (2017). "Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden". Genome Medicine. 9 (1). doi:10.1186/s13073-017-0424-2. ISSN 1756-994X. {{cite journal}}: Explicit use of et al. in: |first3= (help)CS1 maint: unflagged free DOI (link)
  31. ^ Molika Ashford (September 12, 2017). "Foundation Medicine Positions Blood-Based TMB Test as Companion Dx to First-Line Immunotherapy". Genome Web. Retrieved 18 January 2018.

Official website

Category:Biotechnology companies of the United States Category:Companies based in Cambridge, Massachusetts Category:Companies listed on NASDAQ Category:Genomics companies Category:Health care companies based in Massachusetts

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