| February 1995 | Exact Sciences is founded |
| February 2001 | Initial Public Offering |
| April 2009 | Kevin Conroy becomes President and Chief Executive Officer |
| August 2009 | Graham Lidgard, PhD is appointed Chief Science Officer |
| July 2011 | Begins enrolling DeeP-C, the pivotal clinical study to support FDA approval for Cologuard®, the first and only noninvasive stool DNA colorectal cancer screening test |
| November 2012 |
Completes enrollment of DeeP-C clinical study |
| December 2012 |
Submits first module of the premarket approval application (PMA) for Cologuard to FDA |
| February 2013 |
Submits second module of PMA for Cologuard to FDA |
| April 2013 | Announces DeeP-C clinical study top-line results |
| June 2013 | Submits final module of PMA for Cologuard to FDA |
| March 2014 |
FDA holds panel meeting to discuss Cologuard submission Results from DeeP-C study published online in the New England Journal of Medicine FDA Advisory Committee unanimously recommends approval of Cologuard |
| April 2014 | Results from DeeP-C study published in the New England Journal of Medicine’s April 2014 print issue |
| August 2014 |
FDA approves Cologuard and Exact Sciences receives proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS), the first time FDA and CMS simultaneously reviewed a medical device as part of the parallel review pilot program Mayo Clinic becomes first healthcare system to offer Cologuard |
| October 2014 | CMS begins covering Cologuard after issuing final National Coverage Determination (NCD) |
| November 2014 |
The American Cancer Society (ACS) includes Cologuard in its colorectal cancer screening guidelines CMS issues final payment price for Cologuard |
| February 2015 | Announces five-year extension and expansion of collaboration with Mayo Clinic |
| October 2015 |
United States Preventive Services Task Force (USPSTF) draft guidelines include Cologuard as alternative screening test for colorectal cancer Mayo Clinic Proceedings publishes Alaska Native study, supporting Cologuard performance and ability to improve access to screening |
| June 2016 | Final USPSTF guidelines include Cologuard on equal standing among other colorectal cancer screening options |
| October 2016 | The National Committee for Quality Assurance (NCQA) includes Cologuard in their Healthcare Effectiveness Data and Information Set (HEDIS) quality measures |
| April 2017 | CMS includes Cologuard in updated Medicare Advantage Star Ratings |
| August 2017 | Acquires Sampleminded to bolster IT capabilities |
| August 2018 | Announces agreement with Pfizer to co-promote Cologuard |
| October 2018 | Acquires Biomatrica, a leading provider of DNA preservation technology |
| June 2019 | Opens new 169,000 square foot clinical laboratory and warehouse in Madison, WI |
| July 2019 | Becomes a Great Place to Work-Certified™ company |
| September 2019 | FDA expands Cologuard approval to eligible 45 to 49 year olds, from 50 and over |
| October 2019 | Initiates BLUE-C prospective study to support FDA approval for a next-generation Cologuard and a colon cancer blood test |
| November 2019 | Combines with Genomic Health, creating a leading global cancer diagnostics company |
| March 2020 |
Acquires Paradigm and Viomics to provide a differentiated late-stage therapy selection test and deep capabilities in sequencing and biomarker discovery Partners with Wisconsin Clinical Lab Network to develop and launch a COVID-19 test to help meet increasing demand |
| October 2020 |
Extends and amends Cologuard promotion agreement with Pfizer Introduces the Oncotype MAP™ Pan-Cancer Tissue test to help guide treatment for patients with advanced cancer Announces acquisition of Thrive Earlier Detection Acquires Base Genomics to advance DNA methylation capabilities USPSTF draft update includes colorectal cancer screening beginning at age 45 |
| December 2020 |
RxPONDER study results demonstrate that Oncotype DX Breast Recurrence Score® results can spare chemotherapy use in the majority of women with node-positive early-stage breast cancer Provides grant to support Stand Up to Cancer initiative to improve colorectal cancer screening and prevention in medically underserved communities |
| January 2021 |
Completes acquisition of Thrive Earlier Detection to advance blood-based, multi-cancer early detection testing Announces prospective data demonstrating low false-positive rate for Cologuard when screening average risk people ages 45-49 for colorectal cancer Licenses Targeted Digital Sequencing Method (TARDIS) from TGen to support entrance into minimal residual disease testing |
| February 2021 | Announces acquisition of Ashion Analytics and enters into research collaboration with City of Hope's Genomics Institute, TGen |
| March 2021 | Launches public service announcement with Stand Up to Cancer to increase awareness of colorectal cancer |
| April 2021 |
Completes acquisition of Ashion Analytics from TGen, an affiliate of City of Hope Acquires PFS Genomics to reduce unnecessary radiotherapy treatment in patients with early-stage breast cancer |
| May 2021 |
USPSTF issues final recommendation, lowering the starting age for colorectal cancer screening to 45 from 50 Launches early access program for Oncoguard™ Liver, a test to help identify hepatocellular carcinoma (HCC) for adults suffering from liver cirrhosis or chronic hepatitis B |
| August 2021 | Receives regulatory approval for the Oncotype DX Breast Recurrence Score program in Japan |
| September 2021 | Announces clinical validation study to detect minimal residual disease in colorectal cancer patients with National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| November 2021 |
Commences collaboration with Jefferson Health on multi-cancer earlier detection (MCED) test Publishes 20-year data in Urologic Oncology validating adverse pathology as predictor of prostate cancer outcomes in clinically low-risk patients, supporting use of the Oncotype DX GPS test |
| December 2021 | New England Journal of Medicine publication of RxPONDER results confirms that tens of thousands of women with node-positive, early-stage breast cancer can avoid chemotherapy with the Oncotype DX test |
| January 2022 |
Acquires PreventionGenetics to expand use of hereditary cancer testing (HCT) Announces licensing agreement with OncXerna Therapeutics to help predict immunotherapy response for more patients Presents data showing improved accuracy of next-generation Cologuard test |
| August 2022 | Announces new study with West German Study Group to validate detection of minimal residual disease in early-stage breast cancer patients |
| September 2022 | Awards FOCUS grants to Federally Qualified Health Centers focused on improving colorectal cancer screening of vulnerable populations |
| January 2023 | Medicare and insurance policy updates remove patient colonoscopy cost following a positive Cologuard test |
| February 2023 | Launches OncoExTra™ therapy selection test in the United States |
| June 2023 | Announces positive top-line results from the pivotal BLUE-C study evaluating next-generation Cologuard test |
