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Exact Sciences Corp.

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This article is about an American bioscience company. For the branch of sciences, see Exact sciences.

Exact Sciences Corp. is an American molecular diagnostics company based in Madison, Wisconsin 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]

Exact Sciences Corp.
Company typePublic
IndustryMolecular diagnostics
Founded1995; 29 years ago (1995) in Marlborough, Massachusetts
Founders
  • Stanley Lapidus
  • Anthony P. Shuber
HeadquartersMadison, Wisconsin, U.S.
Key people
ProductsCologuard, Oncotype DX, Oncotype MAP
RevenueIncrease US$2.50 billion (2023)
Increase US$−215 million (2023)
Increase US$−204 million (2023)
Total assetsIncrease US$6.47 billion (2023)
Total equityIncrease US$3.15 billion (2023)
Number of employees
6,500 (Dec 2023)
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

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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]

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]

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][non-primary source needed] 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][non-primary source needed]

Acquisition history

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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

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Since 2009, Exact Sciences has maintained a collaboration with Mayo Clinic for its current and future products.[27][non-primary source needed] 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]

Products

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Current Products

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Product type Product Cancer targeted Purpose Launch year Availability Additional information
Screening Cologuard™ Colorectal Detection of colorectal neoplasia associated DNA markers and for the presence of occult haemoglobin in human stool 2014 US only In 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]
Screening Riskguard™ Multiple Detection of genetic mutations to assess hereditary cancer risk by means of a blood and saliva sample 2024 US only Developed by and offered through Exact Sciences' subsidiary PreventionGenetics.
Screening Oncoguard® Liver Liver Blood-based Screening for common liver cancer in individuals suffering from cirrhosis or hepatitis B 2022 US only
Precision Oncology Oncotype DX Breast DCIS Score® Breast Genomic testing of a patient’s risk for a local recurrence of ductal carcinoma in situ or invasive carcinoma 2011 Over 90 countries
Precision Oncology Oncotype DX Breast Recurrence Score® Breast Genome-based, comprehensive, individualized risk assessment for early-stage invasive breast cancer in adjuvant and neoadjuvant settings 2004 Over 90 countries Since 2015 access to Oncotype DX Breast Recurrence Score testing has been available to all eligible NHS patients in England[38]
Precision Oncology Oncotype DX Colon Recurrence Score® Colorectal Genome-based test to quantify the risk of recurrence of patients with anatomic stage II, MMR-P and stage III A/B colon cancers 2010 Over 90 countries
Precision Oncology OncoExTra® Multiple Solid tumor profiling to aid therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer 2020 US only

Pipeline

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Product Cancer targeted Purpose Launch year Availability Additional information
Cancerguard™ Multiple Early detection of cancerous cells through identification of tumor DNA circulating in the blood by means of a blood draw Under development Unknown Initial development by Thrive Early Detection Corp.
Oncotype DX Breast Radiation Score® Breast Genomic testing to establish the possible benefit a patient may expect from undergoing post-operative radiation therapy Under development Unknown
Oncodetect™ Multiple Periodic monitoring of solid tumor DNA circulating in the blood to establish any ongoing presence of cancer post-treatment Under development Unknown
Oncoliquid™ Multiple Blood test to provide therapy selection guidance in cases of advanced cancer Under development Unknown

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:[citation needed]

  • 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

Former Products

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Product Cancer targeted Purpose Launch year Availability Additional information
Oncotype DX AR-V7 Nucleus Detect® Prostate Detection of acquired resistance to AR-targeted therapy via liquid biopsy assay that analyzes circulating tumor cells in a patient's blood 2018 US only Developed by Epic Sciences and commercialised through a partnership with Exact Sciences in the United States.
Oncotype DX Genomic Prostate Score® Prostate Genomic assay testing for men with clinically low- or intermediate-risk cancer to help make treatment decisions at the time of diagnosis 2013 Over 90 countries

References

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  1. ^ "Exact Sciences Corporation 2023 Annual Report (Form 10-K)". U.S. Securities and Exchange Commission. 21 February 2024.
  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. Archived from the original on 29 July 2019. Retrieved 28 Apr 2021.
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