Exact Sciences (company)

Exact Sciences Corp. is a molecular diagnostics company specializing in the detection of early stage cancers. The company's initial focus was on the early detection and prevention of colorectal cancer, in 2014 it launched Cologuard, the first stool DNA test for colorectal cancer. Since then Exact Sciences has grown its product portfolio to encompass other screening and precision oncological tests for other types of cancer.[3]

This article is about an American bioscience company. For the branch of sciences, see Exact sciences.
Exact Sciences Corporation
TypePublic
IndustryMolecular diagnostics
Founded1995 (1995) in Marlborough, Massachusetts
Founders
  • Stanley Lapidus
  • Anthony P. Shuber
HeadquartersMadison, Wisconsin, U.S.
Key people
  • Kevin Conroy
  • (Chairman, President & CEO)
  • Jorge Garces
  • (Chief Science Officer)
ProductsCologuard, Oncotype DX, Oncotype MAP
RevenueIncrease US$2.08 billion (2022)
Increase US$−594 million (2022)
Decrease US$−624 million (2022)
Total assetsDecrease US$6.23 billion (2022)
Total equityDecrease US$3.04 billion (2022)
Number of employees
6,400 (Dec 2022)
Subsidiaries
Subsidiary List
  • Biomatrica
  • Exact Sciences Development
  • Exact Sciences Innovation
  • Exact Sciences International
  • Exact Sciences Laboratories
  • Exact Sciences Thrive
  • Genomic Health
  • Paradigm Diagnostics
  • Prevention Genetics
Websiteexactsciences.com
Footnotes / references
[1][2]

History

Exact Sciences was founded in 1995 in Marlborough, Massachusetts by Stanley Lapidus and Anthony Shuber as a company focused on the development of a non-invasive test for colorectal cancer. The company eventually went public with an initial offering on the NASDAQ in 2001. In the early years, there was much speculation that the company would be acquired by a competitor or exit the market; during this time the company's share price fell to less than one dollar.[4][5][6]

A significant turnaround in the company's fortunes began with the announcement of a mutual collaboration and licensing agreement between Exact Sciences and the Mayo Clinic in June 2009. In the same year, the company appointed Kevin Conroy as CEO & president and moved its head office to Madison, Wisconsin.[7][8][9][10]

In August 2014, Exact Sciences received premarket approval from the Food and Drug Administration for the use and marketing of its flagship product, Cologuard. This breakthrough heralded the beginning of a period of rapid growth for Exact Sciences and the start of its first foray into the acquisitions market.[11]

In August 2017, the company made its first major acquisition when it purchased Sampleminded, a healthcare information technology company based in Salt Lake City, Utah, for $3.2 million. This was followed by the January 2018 announcement that Exact Sciences had completed a $690 million convertible bond offering and the revelation that the company was to acquire Armune Bioscience, a cancer diagnostic developer based in Kalamazoo and Ann Arbor, Michigan (announced during that year's J.P Morgan Healthcare Conference).[12][13] Third-quarter financial reports revealed the price of the Armune Bioscience acquisition to be valued at $12 million, plus $17.5 million in incentives for certain milestones.[14] Later, in October 2018, Exact Sciences announced its purchase of Biomatrica, a developer of sample preservation technology based in San Diego, California.[15][16][17] Financial reports revealed the purchase price to be $20 million with an additional $20 million in incentives for certain milestones.

In summer 2019, Exact Sciences opened a new 169,000 square feet lab and warehouse facility to expand its testing capacity for Cologuard and, in its largest acquisition yet, announced its intention to buy Genomic Health, a genetic cancer detection company based in Redwood City, California, for $2.8 billion. The reason given for this latest acquisition was to both expand Exact Sciences' product portfolio through the addition of Genomic Health's OncotypeIQ suite of precision tests, and expand into other markets outside the US on the back of Genomic Health's existing network.[18][19][20][21] The deal with Genomic Health led to the opening of Exact Sciences offices in the United Kingdom, France, Germany, Italy and Japan, and the foundation of Exact Sciences International, with its headquarters initially in Geneva and later in Zug, Switzerland.

In March 2020, Exact Sciences purchased Paradigm Diagnostics and Viomics, two companies based in Phoenix, Arizona that would expand their lab testing and research and development capabilities.[22] Later, in October 2020, the company again announced a round of acquisitions - this time of Thrive Earlier Detection Corp. (based in Cambridge, Massachusetts) and Base Genomics (based in Oxford, England), two companies specializing in one of Exact Sciences' pipeline areas - blood-based cancer screening.[23]

Exact Sciences responded to the 2020 COVID-19 pandemic by temporarily refocusing a portion of its diagnostic capacity to testing for the disease. The company received FDA regulatory approval to provide home testing kits in April 2020, becoming one of the first companies in the U.S. to do so.[24]

In early 2021, Exact Sciences announced its acquisition of Ashion Analytics and plans to collaborate in research with TGen, the City Of Hope's Genomics Institute.[25] This news came shortly after the company's decision to purchase an exclusive-use license of TGen's proprietary liquid biopsy-based test technology, Tardis.[26]

Acquisition history
Exact Sciences' Cologuard screening laboratory and warehouse in Madison, Wisconsin.
A Cologuard test package, ready for return to the lab using the pre-paid UPS shipping label.

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

Exact Sciences

Exact Sciences Corp.
(Founded 1995)

Sampleminded
(Acq 2017)

Armune Bioscience
(Acq 2018)

Biomatrica
(Acq 2018)

Genomic Health
(Acq 2019)

Paradigm Diagnostics
(Acq 2020)

Viomics
(Acq 2020)

Thrive Earlier Detection Corp.
(Acq 2020)

Base Genomics
(Acq 2020)

Partnerships

Since 2009, Exact Sciences has maintained a collaboration with Mayo Clinic for its current and future products.[27] In 2009, Exact Sciences also completed a licensing agreement with Hologic for its molecular detection platform.[28] In April 2017, Exact Sciences and MDxHealth agreed to share technology on a variety of epigenetics and molecular diagnostics applications for five years.[29] In August 2018, Exact Sciences and Pfizer announced an agreement through 2021 to co-promote Cologuard.[30] In November 2018, Exact Sciences announced a partnership with Epic Systems for order entries.[31]

Exact Sciences has, since 2015, been sponsor of the Cologuard Classic, a professional golf tournament on the PGA Tour Champions tournament circuit held annually at the Catalina Course of the Omni Tucson National Resort, in Tucson, Arizona.

Products
ProductCancer targetedPurposeLaunch yearAvailabilityAdditional information
Cologuard™ColorectalDetection of colorectal neoplasia associated DNA markers and for the presence of occult haemoglobin in human stool2014US onlyIn August 2014, the U.S. Food and Drug Administration (FDA) approved the company's at-home multitarget stool DNA screening test called Cologuard, for the detection of colorectal cancers and pre-cancers.[32][33][34][35][36]
This test has a false positive rate of 13%.[37]
Oncotype DX® AR-V7 Nucleus DetectProstateDetection of acquired resistance to AR-targeted therapy via liquid biopsy assay that analyzes circulating tumor cells in a patient's blood2018US onlyDeveloped by Epic Sciences and commercialised through a partnership with Exact Sciences in the United States.
Oncotype DX® Breast DCIS ScoreBreastGenomic testing of a patient’s risk for a local recurrence of ductal carcinoma in situ or invasive carcinoma2011Over 90 countries
Oncotype DX® Breast Recurrence ScoreBreastGenome-based, comprehensive, individualized risk assessment for early-stage invasive breast cancer in adjuvant and neoadjuvant settings2004Over 90 countriesSince 2015 access to Oncotype DX Breast Recurrence Score testing has been available to all eligible NHS patients in England[38]
Oncotype DX® Colon Recurrence ScoreColorectalGenome-based test to quantify the risk of recurrence of patients with anatomic stage II, MMR-P and stage III A/B colon cancers2010Over 90 countries
Oncotype DX® Genomic Prostate ScoreProstateGenomic assay testing for men with clinically low- or intermediate-risk cancer to help make treatment decisions at the time of diagnosis2013Over 90 countries
Oncotype MAP™ Pan Cancer TissueMultipleTumor profiling to aid therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer2020US only

Pipeline

Pipeline products include esophageal, breast, lung, liver, and pancreatic cancer testing. The company is also working with the Mayo Clinic to identify biomarkers associated with the 15 deadliest cancers.[39] Other initiatives focus on:

  • Using experience gained from the development of Cologuard to create a wider cancer detection platform
  • Expanding the range Oncotype IQ products to include liquid and tissue-based tests
  • Adapting biomarker-based technologies create a liquid biopsy capable of detecting cancers and precancers from a blood sample
  • Improving analytical sensitivity using the company's existing multi-marker approach to better identify cancerous samples

References
  1. "Exact Sciences Corporation 2022 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 21 February 2023.
  2. Jeff Clemetson (22 March 2022). "Exact Sciences Expands San Diego Footprint". San Diego Business Journal.
  3. Newman, Judy (31 Aug 2014). "Exact Sciences' Cologuard cancer test debuts". Madison. Retrieved 30 Jul 2019.
  4. "EXACT SCIENCES CORP (EXAS) IPO". Nasdaq. 31 Jan 2001. Retrieved 30 Jul 2019.
  5. Hennessey, Raymond (1 Feb 2001). "Exact Sciences IPO Gains, Breaks Price-Cutting Trend". WSJ. Retrieved 30 Jul 2019.
  6. Timmerman, Luke (18 Dec 2013). "Exact Sciences, Once Near Death, Bounces Back With Colon Cancer Test". Xconomy. Retrieved 21 Apr 2021.
  7. "Exact Sciences Corp". Bloomberg. Retrieved 20 Jun 2018.
  8. McBride, Ryan (18 Jun 2009). "Exact Sciences Moving to Wisconsin". Xconomy. Retrieved 9 Sep 2015.
  9. "EXACT Sciences Corporation Closes $8.2-Million Private Placement, Enters Into Licensing and Collaboration Agreement". Biospace. 12 Jun 2009. Retrieved 29 Jul 2019.
  10. "Exact Sciences Licenses Mayo Clinic IP; Closes $8.2M Placement". GenomeWeb. 12 Jun 2009.
  11. "Premarket Approval (PMA)". FDA. 13 Aug 2014. Retrieved 29 Jul 2019.
  12. "XMS Capital Partners Serves as Financial Advisor to Exact Sciences on $600 Million Convertible Notes Offering" (Press release). 24 Jan 2018.
  13. Sarah, Stevenson (26 Jan 2018). "Armune Bio's Cancer Detection Tech Finds New Home with Exact Sciences". Xconomy. Retrieved 29 Jul 2019.
  14. Newman, Judy (3 Nov 2018). "Exact Sciences signs deal with Epic Systems, hikes sales, widens losses". Madison. Retrieved 29 Jul 2019.
  15. Buchanan, Jeff (18 Oct 2018). "Exact Sciences Acquires San Diego Lab Equipment Supplier Biomatrica". Xconomy. Retrieved 30 Jul 2019.
  16. "Exact Sciences Acquires Sample Preservation Technology Provider Biomatrica". 360dx. 18 Oct 2018. Retrieved 30 Jul 2019.
  17. House, Douglas (18 Oct 2018). "Exact Sciences acquires Biomatrica". seekingalpha. Retrieved 29 Jul 2019.
  18. Williams, Nick (27 Jun 2019). "Exact Sciences opens new lab in Madison to process Cologuard test". bizjournals. Retrieved 29 Jul 2019.
  19. "Exact Sciences to buy Genomic Health for $2.8 billion". CNBC. 29 Jul 2019. Retrieved 29 Jul 2019.
  20. Feroldi, Brian (29 Jul 2019). "Why Exact Sciences Is Sinking and Genomic Health Is Rising". Fool. Retrieved 29 Jul 2019.
  21. Flanagan, Cristin; Ahmed, Nabila (29 Jul 2019). "Exact Sciences to Buy Genomic Health for About $2.8 Billion". Bloomberg. Retrieved 29 Jul 2019.
  22. "Phoenix Based Paradigm And Viomics Acquired by Exact Sciences". Arizona Bioindustry Association. 6 March 2020. Retrieved 26 May 2020.
  23. "Exact Sciences stock soars with acquisitions of 2 blood-based cancer screening firms for $2.56B". Wisconsin State Journal. 20 Oct 2020.
  24. Boulton, Guy (31 Aug 2020). "Exact Sciences wins regulatory approval for home COVID-19 tests; home test must be ordered by clinician, then sent to lab for analysis". Milwaukee Journal Sentinel. Retrieved 21 Apr 2021.
  25. Sciences, Exact (16 Feb 2021). "Exact Sciences to Acquire Ashion Analytics and Enter Research Collaboration with City of Hope's Genomics Institute, TGen". Cision. Retrieved 21 Apr 2021.
  26. Sciences, Exact (13 Jan 2021). "Exact Sciences Licenses Targeted Digital Sequencing Method to Extend Leadership in Precision Oncology". Cision. Retrieved 21 Apr 2021.
  27. "Exact Sciences Advances Pipeline Capabilities with Mayo Clinic". prnewswire. 20 May 2019. Retrieved 29 Jul 2019.
  28. "Exact Sciences licenses Hologic's Invader diagnostics line". massdevice. 23 Oct 2009. Retrieved 29 Jul 2019.
  29. "MDxHealth, Exact Agree to Collaborate on Epigenetics and MDx". genengnews. 17 Apr 2017. Retrieved 29 Jul 2019.
  30. "Xconomy: Exact Sciences Shares Rise After Company Unveils Pfizer Partnership". Xconomy. 22 Aug 2018. Retrieved 21 May 2019.
  31. Spitzer, Julie (12 Nov 2018). "Epic signs agreement with Exact Sciences: 4 things to know". beckershospitalreview. Retrieved 29 Jul 2019.
  32. Philippidis, Alex (13 Aug 2014). "FDA Approves First Noninvasive Colorectal Cancer Test". Clinicalomics. Retrieved 30 Jul 2019.
  33. "FDA Approves First Non-invasive DNA Screening Test for Colorectal Cancer". esmo. 13 Aug 2014. Retrieved 30 Jul 2019.
  34. Warren, Rachel (13 Aug 2014). "FDA Approves DNA Screening Test for Colorectal Cancer". CancerNetwork. Retrieved 30 Jul 2019.
  35. Edney, Anna (12 Aug 2014). "Exact Sciences Wins U.S. Approval for Colon Cancer Test". Bloomberg. Retrieved 9 Sep 2015.
  36. Schattner, Elaine (6 Mar 2015). "For Colon Cancer Screening, Cologuard Test Offers A Solid New Option". Forbes. Retrieved 9 Sep 2015.
  37. Fisher, Deborah (31 Aug 2014). "Facts, Myths, and the Stool DNA Test". Medpagetoday. Retrieved 29 Jul 2019.
  38. Staff Reporter (5 Feb 2015). "UK's NHS Adopts NICE Advice to Provide Oncotype DX for Intermediate Risk Breast Cancer Patients". Genome Web. Retrieved 21 Apr 2021.
  39. "The Pipeline". ExactSciences. Retrieved 28 Apr 2021.
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