Effective August 2, 2022, mdxhealth has acquired the Oncotype DX GPS (Genomic Prostate Score) test from Exact Sciences. To help ensure a smooth transition for patients, continue to place orders for this test through the existing Exact Sciences portal until further notice. Additionally, Genomic Health Inc, part of Exact Sciences, will continue to perform the Oncotype DX GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the following press release. Questions? Email: gps@mdxhealth.com

Company History

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