Exact Sciences Corporation and its subsidiaries (Exact) is a provider of cancer screening and diagnostic tests.
The company gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard and Oncotype DX tests, the company is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis.
Products and Services
With a leading portfolio of products for earlier cancer de...
Exact Sciences Corporation and its subsidiaries (Exact) is a provider of cancer screening and diagnostic tests.
The company gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard and Oncotype DX tests, the company is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis.
Products and Services
With a leading portfolio of products for earlier cancer detection and treatment guidance, the company provides patients with earlier, smarter answers. The company’s products and services focus on screening and precision oncology tests.
Screening Tests
Cologuard Test
The company’s flagship screening product, the Cologuard test, is a patient-friendly, non-invasive, stool-based DNA (sDNA) screening test that utilizes a multi-target approach to detect DNA and hemoglobin biomarkers associated with colorectal cancer and pre-cancer. Eleven biomarkers are targeted that have been shown to be strongly associated with colorectal cancer and pre-cancer. Methylation, mutation, and hemoglobin results are combined in the laboratory analysis through a proprietary algorithm to provide a single positive or negative reportable result.
The large, underserved population of unscreened and inadequately screened patients represents a significant opportunity for the company’s Cologuard test.
Upon approval by the FDA in August 2014, the company’s Cologuard test became the first and only FDA-approved sDNA non-invasive colorectal cancer screening test. The company’s Cologuard test is indicated for average risk adults 45 years of age and older.
The company’s Cologuard test helps more people get screened for colorectal cancer.
Genetic Testing
The company has an extensive menu of predefined genetic tests for nearly all clinically relevant genes, additional custom panels, and comprehensive germline, whole exome (PGxome), and whole genome (PGnome) sequencing tests.
Precision Oncology Tests
The company’s precision oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. It enables patients to take a more active role in their cancer care and make it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations.
Oncotype DX Breast Recurrence Score Test
The company’s Oncotype DX Breast Recurrence Score test has been demonstrated to identify patients who are most likely to benefit from chemotherapy, as well as those who may receive no clinical benefit from chemotherapy.
The Oncotype DX Breast Recurrence Score test examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of the patient’s individual disease. The test is supported by multiple rigorous clinical validation studies, including the landmark TAILORx and RxPONDER studies, confirming the test’s ability to predict the likelihood of chemotherapy benefit, as well as the chance of cancer recurrence in the most common sub-type of early-stage breast cancer.
As the only test proven to predict both the likelihood of chemotherapy benefit and cancer recurrence, the Oncotype DX Breast Recurrence Score test is recognized globally as standard of care and is included in all major breast cancer treatment guidelines.
Oncotype DX Breast DCIS Score Test
The company’s Oncotype DX Breast DCIS Score test provides ductal carcinoma in situ (DCIS) patients an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma), represented by a DCIS Score result. This test helps guide treatment decision-making in women with DCIS treated by local excision, with or without tamoxifen. Development of the company’s Oncotype DX Breast DCIS Score test was based on published results for the Oncotype DX Breast Recurrence Score test that showed similarity in the expression profiles of genes between DCIS and invasive breast cancer when both are present within the same patient tumor.
Oncotype DX Colon Recurrence Score Test
In patients with stage II and stage III colon cancer, the decision to treat with chemotherapy following surgery is based on an assessment of the likelihood of cancer recurrence, and as a result, it is critical for clinicians to accurately assess a patient’s risk of recurrence. The company’s Oncotype DX Colon Recurrence Score test is a multi-gene test for predicting recurrence risk in patients with stage II and stage III A/B colon cancer to enable an individualized approach to treatment planning. By evaluating specific genes within a patient’s colon tumor, the test can determine the likelihood that the cancer cells will spread and cause the disease to return after surgery. Based on this information, healthcare providers and patients can make more informed treatment decisions. The Oncotype DX Colon Recurrence Score test is supported by three rigorous clinical validation studies confirming the test’s ability to provide additional and independent value beyond the used measures for determining colon cancer recurrence risk.
OncoExTra Test
In April 2021, the company began performing and selling the OncoExTra test, previously known as GEM ExTra, as a result of its acquisition of Ashion Analytics, LLC (Ashion). The OncoExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today.
Riskguard Test
Riskguard, the company’s hereditary cancer test, helps people understand their inherited risk of cancer, arming them with critical information to make more informed treatment decisions.
COVID-19 Testing Business
The company discontinued its COVID-19 testing operations in the second quarter of 2023. From March 2020 through June 2023, the company partnered with various customers, including the State of Wisconsin Department of Health Services, to administer testing. Customers were responsible for employing trained personnel to collect specimens. Specimens were sent to the company’s laboratory in Madison, Wisconsin, where it ran the assay in its laboratories and provided test results to ordering providers.
Upcoming Test Launches
The company is preparing to launch three new tests in 2025 across the largest patient impact opportunities in cancer diagnostics.
Cologuard Plus - The Cologuard Plus test, which features novel biomarkers, improved laboratory processes, and enhanced sample stability, detects colorectal cancers and precancerous polyps with even greater sensitivity than its Cologuard test while reducing false positives by nearly 40%. Results from the pivotal BLUE-C study published in the New England Journal of Medicine in March 2024 showed 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy. In October 2024, the FDA approved the company’s Cologuard Plus test for adults ages 45 and older of average risk for colorectal cancer. The company expects to launch its Cologuard Plus test with Medicare coverage and guideline inclusion in the second quarter of 2025.
Oncodetect – The company’s tumor-informed Oncodetect MRD test is designed to detect small amounts of tumor DNA that may remain in patients’ blood after they have undergone initial treatment. This test is expected to help patients and oncologists understand the success of initial treatment, guide further treatment, and monitor for cancer recurrence. Results from the Alpha-CORRECT study, which primarily included patients with stage III colorectal cancer, showed its Oncodetect test achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively. In January 2025, complete findings from Alpha-CORRECT were published in the Journal of Surgical Oncology. Results from its Beta-CORRECT study, which it expects to present at an upcoming scientific conference, confirm a significant association between MRD positivity and recurrence in patients with stages II through IV colorectal cancer. Based on results from these two studies, it expects to launch the test as a laboratory developed test (LDT) with Medicare reimbursement through the Molecular Diagnostic Services Program (MolDX) in the second quarter of 2025.
Cancerguard – The company’s Cancerguard test is designed to detect multiple cancers in their earliest stages from a single blood draw. Building on decades of research with Mayo Foundation for Medical Education and Research (Mayo) and The Johns Hopkins University (JHU), the Cancerguard test combines multiple biomarker classes for earlier cancer detection, provides high specificity to help minimize false positives, and utilizes a streamlined imaging-based diagnostic pathway to reduce follow-up procedures. In November 2024, results from a multi-center, prospective, case-control ASCEND-2 study showed 60% overall sensitivity at 98.5% specificity when excluding cancer organ types with average-risk standard of care screening, and 67% overall sensitivity for the six most aggressive cancer organ types with the shortest 5-year survival rate. The company expects to launch the test as an LDT in the second half of 2025.
Pipeline Research and Development
The company is continuing to advance its pipeline of future screening and diagnostic products, including risk assessment, screening and prevention, early disease diagnosis, adjuvant and/or neoadjuvant disease treatment, metastatic disease treatment selection, and recurrence monitoring.
Through the company’s collaboration with Mayo, it has successfully performed feasibility studies involving multiple types of cancer using tissue, blood, and other sample types. Its research and development programs are also powered by technologies the company has exclusively licensed from JHU, Broad Institute, Inc. (Broad Institute), Oxford University, the Ludwig Institute for Cancer Research, and TwinStrand Biosciences, Inc. (TwinStrand).
The company is focusing its research and development efforts on three main areas:
Colorectal Cancer Screening Test Development: Beyond Cologuard Plus, the company is working to develop a blood-based screening test for colorectal cancer. In September 2024, it presented performance data for the company’s blood-based colorectal cancer screening test at the ESMO Congress, showing sensitivities of 88% for colorectal cancer and 31% for advanced precancerous lesions at specificity of 90% for negative samples confirmed by colonoscopy. BLUE-C pivotal study results for its blood-based colorectal cancer screening test are expected in the middle of 2025 and performance degradation is expected for advanced precancerous lesion sensitivity and overall CRC sensitivity.
MRD Test Development: In addition to the evidence supporting Oncodetect in colorectal cancer, the company plans to validate its Oncodetect test in breast cancer, and subsequently, in multiple other solid tumor types. It also expects to enhance its MRD test by leveraging the Broad Institute’s Minor Allele Enriched Sequencing Through Recognition Oligonucleotides (MAESTRO) diagnostic testing technology, which the company secured exclusive rights to in June 2023 through a sponsored research and license agreement. The company is developing the MAESTRO platform and expect to analytically validate this technology in 2025.
MCED Test Development: In July 2024, the company’s Cancerguard test was approved as an Investigational Device Exemption by the FDA to be used within a real-world evidence study, providing an opportunity to test 25,000 people over the next three years. The first patient was enrolled within this study at Baylor Scott & White, the primary study site, in August 2024. In the future, it plans to begin recruiting patients for the FDA registrational Study of All comeRs (SOAR) trial, which it expects to be one of the largest prospective, interventional multi-cancer screening trial ever conducted in the U.S.
Commercial Operations
The company’s commercial functions include specific teams focused on screening, precision oncology, and international markets.
Cologuard Test Commercial Operations
The company promotes its Cologuard test through a national and market-based model comprising its health systems, payers, primary care, market development, and inside sales team members.
The company sales team actively engages with healthcare providers and payers to emphasize the need for colorectal cancer screening, educate them on the value of its Cologuard test, and facilitate their ability to order the test. The company focuses on specific healthcare providers and payers based on a combination of Cologuard order history and ordering potential data. It also focusses on healthcare provider groups and larger regional and national health systems through large, organized screening programs.
A critical part of the value proposition of the company’s Cologuard test is its adherence program, which involves active engagement with patients and providers by its adherence team. This customer-oriented support activity is focused on encouraging and helping patients complete Cologuard tests that have been ordered for them by their providers. The company undertakes a variety of health care activities to promote patient adherence, including letters, text messages, online chat, emails, phone calls, and other direct-to-consumer digital efforts.
The company has undertaken a significant marketing public relations effort to engage prospective patients in the U.S., including through the launch of targeted, direct-to-consumer advertising campaigns across national television, digital, social media, print, and audio channels. During 2024, it continued to deepen its investment in large, organized screening programs to further solidify the company’s Cologuard test as a solution for patients who infrequently visit their health care provider.
Precision Oncology Commercial Operations
The company promotes its precision oncology tests through its precision oncology sales force. The company’s commercial infrastructure, including its sales force, managed care group, and patient support network, is critical to the success of its precision oncology products. In the company’s domestic sales, marketing, and reimbursement efforts, it interacts directly with medical, radiation, and surgical oncologists, pathologists, and payers. The company employs a direct sales approach that targets oncologists and cancer surgeons. It also plans to continue to utilize data from its clinical studies published in peer-reviewed journals to demonstrate the clinical value of its precision oncology products. The combination of these approaches is the company’s best means to increase patient and healthcare provider awareness of its precision oncology products and services and the number of favorable reimbursement coverage decisions by third-party payers.
International Commercial Operations
The company commercializes or plans to commercialize its Oncotype tests internationally through employees in Canada, Japan, and a number of European countries, as well as through exclusive distribution agreements. The company has provided its Oncotype tests in approximately 120 countries outside of the U.S. It does not offer the company’s Cologuard test, Cancerguard test, or Oncodetect test outside of the U.S. The company is exploring opportunities to make these tests and other future products available outside of the U.S.
Inclusion of the company’s products in guidelines and quality measures will be critical to its international success. The Oncotype DX breast cancer test is recognized in international guidelines issued by the St. Gallen International Breast Cancer Expert Panel and European Society for Medical Oncology. The company’s Oncotype DX breast cancer test has been recommended to guide certain patients’ chemotherapy treatment decisions by the National Institute for Health and Care Excellence in England, the Gynecologic Oncology Working Group in Germany, and the Japan Breast Cancer Society. Its Oncotype DX breast cancer test is reimbursed for certain patients in the public health systems in more than ten countries.
The company is exploring opportunities to establish local laboratories in certain locations outside of the U.S. and established local testing capacity in Germany beginning in late 2021. Certain countries have severe restrictions on reimbursing tests performed abroad or exporting tissue samples or patient health data. These restrictions limit its ability to offer the company’s tests in those countries without local laboratories or a method of test delivery that does not require samples to be transported to its U.S. laboratory.
Clinical Laboratory and Manufacturing Facilities
The company processes its Cologuard test at two state-of-the-art, high-throughput clinical laboratories in Madison, Wisconsin that are certified pursuant to federal Clinical Laboratory Improvement Amendments (CLIA) and accredited by College of American Pathologist (CAP). The company’s total lab capacity at both facilities is approximately seven million Cologuard tests per year, with the opportunity to add additional capacity, if needed.
The company manufactures its Cologuard and Cologuard Plus tests at its facilities in Madison, Wisconsin. It is committed to manufacturing and providing medical devices and related products that meet customer expectations and applicable regulatory requirements. The company adheres to manufacturing and safety standards required by federal, state, and local laws and regulations and operate its manufacturing facilities under a quality management system. The company purchases certain components for its Cologuard and Cologuard Plus tests from third-party suppliers and manufacturers.
A majority of the company’s internally developed Oncotype tests for domestic and international patients are processed in its CLIA-certified and CAP-accredited clinical reference laboratory facilities in Redwood City, California. Beginning in 2022, Oncotype DX breast cancer tests for German patients have been processed in the company’s newly constructed facility in Trier, Germany, a portion of which is operated by a third-party partner. The company’s OncoExTra tests, along with tests completed under certain of its reference lab agreements, are processed in its CLIA-certified and CAP-accredited clinical reference laboratory facilities in Phoenix, Arizona.
The company processes its predefined genetic tests for nearly all clinically relevant genes, additional custom panels, and comprehensive germline whole exome and whole genome sequencing tests in addition to its hereditary cancer test, Riskguard at its CLIA-certified and CAP-accredited DNA testing laboratory in Marshfield, Wisconsin.
Competition
The company’s precision oncology products compete against a number of companies that are developing or commercializing products to profile genes and gene expression in breast and colon cancer. These companies include Agendia Inc., Veracyte, Inc., Myriad Genetics, Inc., and Hologic, Inc.
The company faces competition from a variety of sources, including Ambry Genetics (owned by Tempus AI); Myriad Genetics, Inc.; Natera; Color Health, Inc.; GeneDx; Illumina; Variantyx; 3billion; a few large, established general testing companies, such as Laboratory Corporation of America Holdings (LabCorp) and Quest Diagnostics Incorporated; and clinical laboratories in an academic or healthcare provider setting that perform clinical genetic testing on behalf of their affiliated institutions.
Regulation
Certain of the company’s activities are subject to regulatory oversight by the United States (U.S.) Food and Drug Administration (FDA) under provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and regulations thereunder, including regulations governing the development, marketing, labeling, promotion, manufacturing, distribution, and export of diagnostic products. The company’s clinical laboratory facilities are subject to oversight by CMS pursuant to CLIA, as well as agencies in various states, including New York.
The company’s Cologuard and Cologuard Plus tests are regulated by the FDA as a Class III medical devices. The FDA granted premarket approval (PMA) for its Cologuard and Cologuard Plus tests in August 2014 and October 2024, respectively.
The company is required to comply with international, national, and provincial personal data protection laws and regulations, including the European Union's (E.U.) General Data Protection Regulation (GDPR) and Japan's Act on the Protection of Personal Information (APPI).
The company is subject to numerous federal and state anti-fraud and abuse laws, including the Federal False Claims Act. Many of these anti-fraud laws are broad in scope, and neither the courts nor government agencies have extensively interpreted these laws. Prohibitions under some of these laws include: the submission of false claims or false information to government programs, the retention of any overpayments by governmental payers, deceptive or fraudulent conduct, excessive or unnecessary services or services at excessive prices, and defrauding private sector health insurers.
As the company’s Oncotype DX Breast Recurrence Score test has a pre-existing certification from its notified body, it had until May 2026 to meet certain of the new, more stringent regulatory requirements of EU IVDR with respect to its Oncotype DX Breast Recurrence Score test, including obtaining a new positive conformity assessment from its notified body. The company received a CE marking on its Oncotype DX Breast Recurrence Score test in December 2023, certifying that it is in compliance with the new EU IVDR regulatory requirements.
The E.U. has amended its existing regulatory framework for in vitro diagnostics by introducing the Regulation 2017/746 (EU) (“EU IVDR”), which amends the existing framework and imposes stricter requirements for the development, marketing, and sale of in vitro diagnostics such as the company’s Oncotype DX Breast Recurrence Score test in the E.U.
The U.S. Foreign Corrupt Practices Act prohibits any U.S. individual, business entity, or employee of a U.S. business entity from offering or providing, directly or through a third party, including the distributors the company relies on in certain markets, anything of value to a foreign government official with corrupt intent to influence an award or continuation of business or to gain an unfair advantage, whether or not such conduct violates local laws.
In addition to its comprehensive regulation of health and safety in the workplace in general, the Occupational Safety and Health Administration has established extensive requirements aimed specifically at laboratories and other healthcare-related facilities. In addition, because the company’s operations require employees to use certain hazardous chemicals, the company also must comply with regulations on hazard communication and hazardous chemicals in laboratories. These regulations require the company, among other things, to develop written programs and plans, which must address methods for preventing and mitigating employee exposure, the use of personal protective equipment, and training.
The company’s commercialization activities subject it to regulations of the Department of Transportation, the U.S. Postal Service, and the Centers for Disease Control and Prevention that apply to the surface and air transportation, as well as importation, of clinical laboratory specimens.
Intellectual Property
As of December 31, 2024, the company had 257 issued patents in the U.S. and 930 issued patents outside of the U.S., which includes validated patents issued by the European Patent Office in key E.U. countries, covering genes and methods that are components of the Cologuard test, Oncoguard Liver test, Oncotype DX tests, pipeline technologies or research methods, and platform technologies. The company’s issued U.S. patents expire at various times between 2025 and 2044. In addition, it has pending patent applications in the U.S. and in other countries, including provisional and non-provisional filings. Some of these U.S. patent applications also have corresponding pending or granted applications under the Patent Cooperation Treaty in Canada, Europe, Japan, Australia, and other jurisdictions.
License Agreements
Mayo Foundation for Medical Education and Research
In June 2009, the company entered into an exclusive, worldwide license agreement with Mayo Foundation for Medical Education and Research, under which Mayo granted it an exclusive, worldwide license to certain Mayo patents and patent applications, as well as a non-exclusive, worldwide license with regard to certain Mayo know-how. The scope of the license covers any screening, surveillance, or diagnostic test or tool for use in connection with any type of cancer, pre-cancer, disease, or condition. Its license agreement with Mayo was most recently amended and restated in September 2020.
The licensed Mayo patents and patent applications contain both method and composition claims that relate to sample processing, analytical testing, and data analysis associated with nucleic acid screening for cancers and other diseases. The jurisdictions covered by these patents and patent applications include the U.S., Australia, Canada, the E.U., China, Japan, and Korea. Under the license agreement, the company assumed the obligation and expense of prosecuting and maintaining the licensed Mayo patents and are obligated to make commercially reasonable efforts to bring to market products using the licensed Mayo intellectual property.
Pursuant to the company’s license agreement with Mayo, it is required to pay Mayo a low-single-digit royalty on net sales of current and future products using the licensed Mayo intellectual property each year during the term of the Mayo agreement.
The license agreement will remain in effect, unless earlier terminated by the parties in accordance with the agreement, until the last of the licensed patents expires in 2043 (or later, if certain licensed patent applications are issued).
In addition to granting the company a license to the covered Mayo intellectual property, Mayo provides it with product development research and development assistance pursuant to the license agreement and other collaborative arrangements. In September 2020, Mayo also agreed to make available certain personnel to provide such assistance through January 2025.
Johns Hopkins University
Through the acquisition of Thrive Earlier Detection Corporation (Thrive), the company acquired a worldwide exclusive license agreement with The Johns Hopkins University for use of several JHU patents and licensed know-how. It is seeking to utilize the JHU licensed technology to develop and commercialize a blood-based MCED test.
In addition to granting the company a license to the covered JHU intellectual property, JHU provides the company with research and development assistance pursuant to other collaboration arrangements.
History
Exact Sciences Corporation was founded in 1995. The company was incorporated in the state of Delaware in 1995.
