The history of Exact Sciences
Founded
1995, 29 years ago
Initial public offering
February 2001
CEO
Kevin Conroy
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.
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 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
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
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
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
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.
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 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 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 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.
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
Early detection in liver cancer
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
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 Institue 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
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
RiskguardTM 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
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.
Looking ahead
As it enters a bright future, Exact Sciences marks 20-year anniversaries of PreventionGenetics and the Oncotype DX Breast Recurrence Score test, as well as the 10-year anniversary of the Cologuard test.
References and footnotes
- 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.