History | Exact Sciences

Founded
1995, 30 years ago

Initial public offering
February 2001

CEO
Kevin Conroy

An Exact Sciences lab technician working in the lab.

1995 to 2013

Bold strides in cancer care

Exact Sciences is founded, aiming to develop a new, convenient colorectal cancer screening option. Researchers striving to find the right science take an innovative approach: screening patients’ stools for abnormal DNA. Meanwhile, the Oncotype DX^® test emerges as a key tool in cancer treatment guidance.

1995

Founding a company

Colorectal cancer (CRC) is a leading cause of cancer-related deaths in the United States. The main screening solution in the 1990s, colonoscopy, yields population health concerns due to cost, convenience, and invasive nature. Engineer Stan Lapidus founds a company in Marlborough, Massachusetts, to address this unmet need.

1998

Patent approval

The U.S. patent diagram exemplifying aspects of the Cologuard® at-home collection kit.

The U.S. patent diagram that exemplifies aspects of the Cologuard^® use-at-home collection kit

Earlier research by Johns Hopkins University's Bert Vogelstein, M.D., shows that certain genes undergo alterations as normal colon cells transform into cancerous ones. This implies that stool could be used to screen for CRC. The company’s foundational patent outlines a method for collecting stool samples.

2001

Taking the company public

Exact Sciences lists on the Nasdaq stock market index under symbol EXAS.

2004

Oncotype DX Breast Recurrence Score^® test launches

A close up of a woman smiling at the camera.

Katherine Y., breast cancer survivor and Oncotype DX ambassador

The Oncotype DX Breast Recurrence Score test helps breast cancer patients understand their individual risk of their cancer recurring. Predicting how likely you are to benefit from chemotherapy allows patients and their healthcare providers to treat cancer with even more confidence. Its maker, Genomic Health, will later be acquired by Exact Sciences.

Founding PreventionGenetics

Dr. James Weber standing in the company's early lab space.

PreventionGenetics founder Dr. James Weber in the company’s early lab space

James Weber, Ph.D., a geneticist and research scientist in Marshfield, Wisconsin, creates a company based on the idea that genetic testing could help diagnose inherited diseases, allowing for earlier treatment. Called PreventionGenetics, the company will later be acquired by Exact Sciences.

2007

Guidelines include Breast Recurrence Score^® test

The Oncotype DX Breast Recurrence Score test is included in the American Society of Clinical Oncology (ASCO^®) guidelines. The next year, the U.S. National Comprehensive Cancer Network (NCCN^®) guidelines add the test.

2009

Kevin Conroy joins Exact Sciences

The Exact Sciences CEO standing in one of our early labs.

CEO Kevin Conroy in an early Exact Sciences lab

After meeting with Mayo Clinic’s David Ahlquist, M.D., Kevin Conroy comes aboard to lead Exact Sciences. With Ahlquist’s and Vogelstein’s findings at the forefront, Conroy charts a new future for the company’s founding idea of using stool to screen for CRC and plans for further innovations in cancer testing.

Restarting the company in Wisconsin

Madison, Wisconsin

Exact Sciences moves the corporate headquarters to Madison, Wisconsin. The new location draws upon the city’s life-sciences culture and talent.

The right approach for CRC screening

Two Exact Sciences executives smiling at the camera.

Dr. David Ahlquist (left) with Exact Sciences Chief Science Officer Graham Lidgard (right)

Biotech veteran Graham Lidgard, Ph.D., becomes Exact Sciences' chief science officer. He collaborates with Ahlquist and others at Mayo Clinic on an approach to test stool for abnormal DNA, as well as the presence of blood cells that indicate that CRC may be present.

2010

Oncotype DX Colon Recurrence Score^® test launches

The Oncotype DX Colon Recurrence Score test provides insights into how likely a patient’s CRC is likely to recur. This enables them to choose treatment based on their tumor’s unique biology.

2011

Landmark CRC screening trial begins

Exact Sciences names its test Cologuard^® and begins a landmark clinical trial. Called DeeP-C, the trial enrolls 10,000 patients at 90 sites.

Oncotype DX Breast DCIS Score^® test launches

Microscopic image of breast cancer tissue

The Oncotype DX Breast DCIS Score test helps quantify the risk of local recurrence in ductal carcinoma in situ (DCIS) breast cancer. It helps patients understand their personal benefit of radiation therapy.

2012

A lab for the Cologuard^® test

The Cologuard test will require unique laboratory infrastructure, so the company decides to build its own lab to process tests. It hires noted lab leader Ana Hooker as chief laboratory officer.

2013

Further inclusion for the Breast Recurrence Score^® test

The Oncotype DX Breast Recurrence Score test is recommended by the National Institute for Health and Care Excellence (NICE)¹ in England and included in the European Society for Medical Oncology (ESMO^®) guidelines.

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A group of seven Exact Sciences technicians in lab coats smiling.

2014 to 2018

Growth and innovation

With solid data and approvals in hand, Exact Sciences introduces the Cologuard test. It quickly attracts notice, being included in major guidelines and health care quality measures and becoming well-known among consumers. A prestigious publication deepens confidence in an Oncotype DX^® test.

2014

Publication of DeeP-C study results

The New England Journal of Medicine publishes results of the DeeP-C study. It shows that the Cologuard test’s performance is superior to that of the fecal immunochemical test, or FIT, the only other noninvasive CRC screening test on the market.2 At the time, the DeeP-C study is one of the largest of its kind.

Approval for the Cologuard test

Exact Sciences learns that the Food and Drug Administration (FDA) has approved the Cologuard test and that the Centers for Medicare and Medicaid Services (CMS) intends to cover its use. This marks the first time the two groups simultaneously reviewed a medical device.

Cologuard^® test launches

A scientist removing a sample container from its shipment box.

A scientist removes a Cologuard sample container from its shipment box.

The Cologuard test is a noninvasive, effective, and affordable prescription-based use-at-home CRC screening test that looks for both abnormal DNA and blood in stool. At the time of launch, it is intended for people age 50 and older of average risk for CRC.

American Cancer Society recommendation

The American Cancer Society includes the Cologuard test in its CRC screening guidelines, which inform clinicians, policymakers, and the public.

2016

USPSTF and HEDIS inclusion

The U.S. Preventive Services Task Force issues recommendations that include putting the Cologuard^® test on equal standing with other CRC screening tests. Later, the National Committee for Quality Assurance includes the Cologuard test in its Healthcare Effectiveness Data and Information Set (HEDIS^®) quality measures.

Introducing Little CG

The Little CG character promotes the Cologuard test on TV.

The Little CG character is created to promote the Cologuard test on TV.

The now-iconic box-shaped character debuts in a television commercial, aiming to make CRC screening friendlier and less scary for consumers.

2017

Medicare Advantage Star Ratings inclusion

CMS includes the Cologuard test in its updated Medicare Advantage Star Ratings program. The program measures how well Medicare Advantage plans perform in several categories, including quality of care. Plans now can help increase their Star Ratings when their beneficiaries complete the Cologuard test.

2018

The first Cologuard^® Classic

The Cologuard Classic team presenting a large check donation.

The Cologuard Classic team presents a donation to the Vince Lombardi Cancer Foundation.

Exact Sciences becomes the presenting sponsor of the PGA TOUR Champions golf tournament in Tucson, Arizona. Called Cologuard Classic, the annual event kicks off Colorectal Cancer Awareness Month, highlighting the importance of screening for CRC and honoring those affected by the disease.

Biomatrica acquisition

Exact Sciences acquires Biomatrica, a leading provider of DNA preservation technology.

Publication of TAILORx study results

The New England Journal of Medicine publishes results of the TAILORx study. It shows that patients with certain Oncotype DX Breast Recurrence Score^® results can safely forgo chemotherapy without compromising survival rates. It also shows that other Breast Recurrence Score results suggest a benefit from chemotherapy.3 TAILORx is the largest randomized adjuvant breast cancer trial ever conducted.

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The Exact Sciences Headquarters building in Madison, Wisconsin.

2019 to present

A global footprint

An acquisition brings together two of the most powerful brands in cancer care: Cologuard^® and Oncotype DX^®. Despite challenges brought by the COVID-19 pandemic, Exact Sciences continues to grow its portfolio, expand its impact, and create more ways to reach more patients in more places.

2019

FDA lowers approval screening age

The FDA lowers the eligibility age for Cologuard testing from 50 to 45 and older. The decision comes at a critical time when the incidence of CRC is rising among American adults younger than 50.⁴

Combines with Genomic Health

Exact Sciences and Genomic Health join to create a leading cancer screening and testing company with two of the strongest and fastest-growing brands in cancer testing: the Cologuard^® test and the Oncotype DX^® tests.

2020

Paradigm and Viomics acquisitions

Exact Sciences acquires Paradigm and Viomics to provide a differentiated late-stage therapy selection test and gain capabilities in sequencing and biomarker discovery.

COVID-19 test development

Exact Sciences COVID-19 collection kit pick-up location

Exact Sciences partners with Wisconsin Clinical Lab Network to develop and launch a COVID-19 test to help meet increasing demand.

Base Genomics acquisition

Exact Sciences acquires Base Genomics to advance its DNA methylation capabilities.

2021

Thrive Earlier Detection acquisition

Exact Sciences acquires Thrive Earlier Detection to advance blood-based multi-cancer early detection (MCED) testing.

Ashion Analytics and PFS Genomics acquisitions

Exact Sciences acquires Ashion Analytics, a CLIA-certified and CAP-accredited sequencing lab. Separately, it also acquires PFS Genomics, which aims to reduce unnecessary radiotherapy treatment in patients with early-stage breast cancer.

USPSTF lowers screening age

The U.S. Preventive Services Task Force releases updated recommendations that CRC screening begin at age 45. The change makes about 19 million additional people eligible for screening.⁵

Oncoguard^® Liver launch

Liver cancer is the fastest-growing cause of cancer-related death in the U.S.⁶ Exact Sciences launches an early access program for the Oncoguard^® Liver test, intended to help identify early-stage hepatocellular carcinoma, the most common type of liver cancer.

Publication of RxPONDER study results

The New England Journal of Medicine publishes results of the RxPONDER study. It demonstrates that certain Oncotype DX Breast Recurrence Score^® test results can spare chemotherapy use in a majority of postmenopausal women with node-positive, early-stage breast cancer.7

2022

PreventionGenetics acquisition

The PreventionGenetics location in Marshfield, Wisconsin.

PreventionGenetics, Marshfield, Wisconsin

Exact Sciences acquires PreventionGenetics to help more patients know their germline risk of cancer and other diseases. A CLIA-certified and CAP-accredited clinical DNA testing laboratory, PreventionGenetics operates as a wholly owned subsidiary of Exact Sciences.

2023

OncoExTra^® cancer therapy selection test launches

A scientist opens an OncoExTra test kit.

The OncoExTra test is a comprehensive DNA- and RNA-based genomic test, providing physicians and their patients a complete molecular picture of the patient’s cancer to help them understand their disease and make treatment decisions.

Broad Institute collaboration

Exact Sciences enters an exclusive license agreement with Broad institute of MIT and Harvard. The company will use the institute’s next-generation technology in its molecular residual disease (MRD) research.

Baylor Scott & White collaboration

Exact Sciences announces a three-year initiative with the health system Baylor Scott & White. The effort will generate real-world evidence by using Exact Sciences’ MCED testing in a clinical setting with support to patients, ordering providers, and clinical staff.

Resolution Bioscience acquisition

Exact Sciences acquires Resolution Bioscience. Its liquid therapy selection platform complements the OncoExTra^® test, allowing Exact Sciences to help more cancer patients determine their most appropriate treatment options.

Reimbursement in Japan

A breast cancer survivor and OncoExTra ambassador from Japan smiling.

Ayako M., breast cancer survivor and Oncotype DX ambassador

Japan’s Ministry of Health, Labor and Welfare begins reimbursement for the Oncotype DX Breast Recurrence Score  test, giving women in Japan broad access to the insights it provides.

2024

Riskguard^TM hereditary cancer test launches

The Riskguard test provides an individualized patient report that includes gene-specific and familial risks using a simple blood or saliva sample for 10 common cancers: colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney, and endocrine.

Publication of BLUE-C study results

Ten years, Two studies, One bright future.

The New England Journal of Medicine publishes results of the BLUE-C study. BLUE-C is designed to reflect the racial and ethnic makeup of the U.S. and is one of the largest CRC screening trials ever conducted. Validating the science behind the next-generation Cologuard^® test shows high cancer sensitivity and specificity and is significantly more likely to detect cancer or precancer when compared to FIT.

2025

A massive screening milestone

20 million Cologuard test results delivered.

The company celebrates 20 million Cologuard^® tests processed.

The Cologuard Plus^® Test launches

The Cologuard Plus test demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, making the trusted noninvasive colorectal cancer screening test even better.*

Freenome Collaboration and License Agreement

Exact Sciences announces an agreement for exclusive U.S. rights to Freenome’s blood-based colorectal cancer screening tests, expanding its leadership in noninvasive screening and advancing access for unscreened patients.

Launch of Cancerguard^®, only-of-its-kind multi-cancer early detection blood test

Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

The Oncodetect^® test launches, advancing the field of MRD

A new test designed to detect molecular residual disease (MRD) across multiple solid tumors, Oncodetect provides patients and clinicians with the insights needed to make more informed decisions throughout the treatment process.

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References and footnotes

94% specificity was determined for adults with no colorectal neoplasia age-weighted to the U.S. population.

Diagnostics Guidance DG34, December 2018. www.nice.org.uk/guidance/dg34 (assessed Oct 2020). All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-2826.
Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281.
Estimates based on US population aged 45-74 and 45-49 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.
Cronin KA, et al. (2018) Cancer.
Kalinsky K, et al. New Engl J Med. 2021.

The history of Exact Sciences

1995 to 2013

Bold strides in cancer care

1995

Founding a company

1998

Patent approval

2001

Taking the company public

2004

Oncotype DX Breast Recurrence Score® test launches

Founding PreventionGenetics

2007

Guidelines include Breast Recurrence Score® test

2009

Kevin Conroy joins Exact Sciences

Restarting the company in Wisconsin

The right approach for CRC screening

2010

Oncotype DX Colon Recurrence Score® test launches

2011

Landmark CRC screening trial begins

Oncotype DX Breast DCIS Score® test launches

2012

A lab for the Cologuard® test

2013

Further inclusion for the Breast Recurrence Score® test

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2014 to 2018

Growth and innovation

2014

Publication of DeeP-C study results

Approval for the Cologuard test

Cologuard® test launches

American Cancer Society recommendation

2016

USPSTF and HEDIS inclusion

Introducing Little CG

2017

Medicare Advantage Star Ratings inclusion

2018

The first Cologuard® Classic

Biomatrica acquisition

Publication of TAILORx study results

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2019 to present

A global footprint

2019

FDA lowers approval screening age

Combines with Genomic Health

2020

Paradigm and Viomics acquisitions

COVID-19 test development

Base Genomics acquisition

2021

Thrive Earlier Detection acquisition

Ashion Analytics and PFS Genomics acquisitions

USPSTF lowers screening age

Oncoguard® Liver launch

Publication of RxPONDER study results

2022

PreventionGenetics acquisition

2023

OncoExTra® cancer therapy selection test launches

Broad Institute collaboration

Baylor Scott & White collaboration

Resolution Bioscience acquisition

Reimbursement in Japan

2024

RiskguardTM hereditary cancer test launches

Publication of BLUE-C study results

2025

A massive screening milestone

The Cologuard Plus® Test launches

Freenome Collaboration and License Agreement

Launch of Cancerguard®, only-of-its-kind multi-cancer early detection blood test

The Oncodetect® test launches, advancing the field of MRD

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References and footnotes #history_references .references-header h2:before { display: none; }

1995 to 2013

Oncotype DX Breast Recurrence Score^® test launches

Guidelines include Breast Recurrence Score^® test

Oncotype DX Colon Recurrence Score^® test launches

Oncotype DX Breast DCIS Score^® test launches

A lab for the Cologuard^® test

Further inclusion for the Breast Recurrence Score^® test

Cologuard^® test launches

The first Cologuard^® Classic

Oncoguard^® Liver launch

OncoExTra^® cancer therapy selection test launches

Riskguard^TM hereditary cancer test launches

The Cologuard Plus^® Test launches

Launch of Cancerguard^®, only-of-its-kind multi-cancer early detection blood test

The Oncodetect^® test launches, advancing the field of MRD

References and footnotes

Oncotype DX Breast Recurrence Score^® test launches

Guidelines include Breast Recurrence Score^® test

Oncotype DX Colon Recurrence Score^® test launches

Oncotype DX Breast DCIS Score^® test launches

A lab for the Cologuard^® test

Further inclusion for the Breast Recurrence Score^® test

Cologuard^® test launches

The first Cologuard^® Classic

Oncoguard^® Liver launch

OncoExTra^® cancer therapy selection test launches

Riskguard^TM hereditary cancer test launches

The Cologuard Plus^® Test launches