Founded
1995, 30 years ago
Initial public offering
February 2001
CEO
Kevin Conroy
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.
Exact Sciences lists on the Nasdaq stock market index under symbol EXAS.
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.
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.
Exact Sciences names its test Cologuard® and begins a landmark clinical trial. Called DeeP-C, the trial enrolls 10,000 patients at 90 sites.
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.
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.
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.
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.
The American Cancer Society includes the Cologuard test in its CRC screening guidelines, which inform clinicians, policymakers, and the public.
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.
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.
Exact Sciences acquires Biomatrica, a leading provider of DNA preservation technology.
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.
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.
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
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.
Exact Sciences acquires Paradigm and Viomics to provide a differentiated late-stage therapy selection test and gain capabilities in sequencing and biomarker discovery.
Exact Sciences acquires Base Genomics to advance its DNA methylation capabilities.
Exact Sciences acquires Thrive Earlier Detection to advance blood-based multi-cancer early detection (MCED) testing.
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.
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
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
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.
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.
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.
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.
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.