Exact Sciences Corp.
| Company type | Public |
|---|---|
| Industry | Molecular diagnostics, cancer diagnostics |
| Founded | 1 January 1995 in Marlborough, Massachusetts, U.S. |
| Founder | Stanley Lapidus, Anthony P. Shuber |
| Headquarters | Madison , United States |
Area served | United States, international (after acquisition of Genomic Health) |
Key people | Kevin Conroy (CEO) |
| Products | Cologuard, Oncotype DX, Oncotype MAP, Riskguard, Oncoguard Liver, OncoExTra |
| Website | www |
Exact Sciences Corp. is a U.S.-based company specializing in molecular diagnostics, with its main office located in Madison, Wisconsin. The firm concentrates on the early identification of cancer. Established in 1995 by entrepreneurs Stanley Lapidus and Anthony P. Shuber, its original focus was on colorectal cancer prevention. A pivotal moment occurred in 2014 with the introduction of Cologuard, the first stool DNA test designed for colorectal cancer screening. Since then, Exact Sciences has diversified its offerings to include precision oncology assays like Oncotype DX and Oncotype MAP, enhancing its market presence and competitive strength in cancer diagnostics.
The company was originally founded in 1995 in Marlborough, Massachusetts by Stanley Lapidus and Anthony Shuber, emphasizing non-invasive tests for colorectal cancer. Exact Sciences went public on the NASDAQ stock exchange in 2001 but initially struggled as its stock price fell below one dollar.
A significant transformation began in June 2009 following a licensing deal with the Mayo Clinic, the appointment of Kevin Conroy as CEO, and relocating its headquarters to Madison, Wisconsin.
In August 2014, Exact Sciences secured FDA premarket approval for its leading product, Cologuard, which initiated rapid expansion and a series of acquisitions. In August 2017, it purchased Sampleminded, a healthcare IT company, for $3.2 million. By January 2018, the company raised $690 million through convertible bonds and announced acquiring Armune Bioscience, a Michigan-based cancer diagnostics developer, for $12 million plus up to $17.5 million in milestone payments. Later that year, Exact Sciences expanded further by acquiring Biomatrica, a San Diego-based firm specializing in sample preservation technologies.
In 2019, Exact Sciences increased its testing capabilities by opening a new 169,000-square-foot laboratory and completed its largest acquisition to date by purchasing Genomic Health for $2.8 billion. This acquisition added Genomic Health’s OncotypeIQ precision testing products to Exact Sciences’ portfolio and extended its operations internationally beyond the United States.
March 2020 saw the acquisition of Paradigm Diagnostics and Viomics in Phoenix to bolster laboratory testing and research & development capacities. By October 2020, Exact Sciences further broadened its reach by acquiring Thrive Earlier Detection Corp., located in Cambridge, Massachusetts, and Base Genomics from Oxford, England—both companies specializing in blood-based cancer detection technologies.
In response to the COVID-19 crisis, Exact Sciences adapted part of its diagnostic resources to SARS-CoV-2 testing and received FDA authorization for home testing kits in April 2020, becoming one of the earliest U.S. companies permitted to offer such tests.
Early in 2021, Exact Sciences acquired Ashion Analytics and initiated a research partnership with the Genomics Institute (TGen) at City of Hope National Medical Center. Additionally, it obtained exclusive rights to TGen’s proprietary liquid biopsy platform, Tardis, further strengthening its precision oncology test portfolio.
Acquisition history
Significant mergers and acquisitions have played a crucial role in shaping Exact Sciences' growth and market position.
Partnerships
Exact Sciences has maintained a collaborative relationship with the Mayo Clinic since 2009 to advance its range of products. That same year, the company secured licensing rights for molecular detection technology from Hologic. In April 2017, Exact Sciences and MDxHealth agreed to a five-year technology-sharing partnership focused on epigenetics and molecular diagnostics. By August 2018, Exact Sciences joined forces with Pfizer to jointly promote Cologuard through 2021. Furthermore, in November 2018, the company partnered with Epic Systems to improve the efficiency of order entry processes.
Current products
| Product type | Product | Cancer targeted | Purpose | Launch year | Availability | Additional information |
|---|---|---|---|---|---|---|
| Screening | Cologuard | Colorectal | At-home detection of DNA markers linked to colorectal neoplasia and occult blood in stool | 2014 | US only | FDA-approved in 2014 as a noninvasive multitarget stool DNA screening test; has a 13% false positive rate. |
| Screening | Riskguard | Multiple | Detection of genetic mutations for hereditary cancer risk assessment using blood and saliva samples | 2024 | US only | Provided via Exact Sciences' subsidiary PreventionGenetics. |
| Screening | Oncoguard Liver | Liver | Blood-based screening designed for liver cancer detection in patients with cirrhosis or hepatitis B | 2022 | US only | |
| Precision Oncology | Oncotype DX Breast DCIS Score | Breast | Genomic assay evaluating local recurrence risk in ductal carcinoma in situ or invasive breast cancer | 2011 | Available in over 90 countries | |
| Precision Oncology | Oncotype DX Breast Recurrence Score | Breast | Genomic test providing individualized recurrence risk assessment for early-stage invasive breast cancer in adjuvant and neoadjuvant contexts | 2004 | Available in over 90 countries | Accessible to all qualifying NHS patients in England since 2015. |
| Precision Oncology | Oncotype DX Colon Recurrence Score | Colorectal | Genomic evaluation quantifying recurrence risk for stage II and III colon cancers | 2010 | Available in over 90 countries | |
| Precision Oncology | OncoExTra | Multiple | Solid tumor profiling test to assist therapy decisions for advanced, metastatic, refractory, or recurrent cancers | 2020 | US only |
Pipeline
| Product | Cancer targeted | Purpose | Launch year | Availability | Additional information |
|---|---|---|---|---|---|
| Cancerguard | Multiple | Early cancer cell detection via circulating tumor DNA analysis in blood samples | In development | Not specified | Originally developed by Thrive Early Detection Corp. |
| Oncotype DX Breast Radiation Score | Breast | Genomic assay assessing potential benefits of postoperative radiation therapy | In development | Not specified | |
| Oncodetect | Multiple | Monitoring circulating tumor DNA after treatment to detect residual cancer presence | In development | Not specified | |
| Oncoliquid | Multiple | Blood-based test guiding therapeutic decisions in advanced cancer cases | In development | Not specified |
Exact Sciences’ development pipeline focuses on cancers including esophageal, breast, lung, liver, and pancreatic types. Collaborative efforts with the Mayo Clinic concentrate on discovering biomarkers associated with the 15 most lethal cancers. Strategic priorities involve building upon Cologuard expertise to broaden cancer detection platforms, expanding Oncotype IQ testing into both liquid biopsy and tissue formats, advancing liquid biopsy technologies for early-stage cancer identification, and improving multi-marker analytical sensitivity to enhance detection accuracy.
Former offerings
| Product | Cancer focus | Function | Year introduced | Market presence | Additional details |
|---|---|---|---|---|---|
| Oncotype DX AR-V7 Nucleus Detect | Prostate | Identifies resistance to androgen receptor-targeted therapies using liquid biopsy to examine circulating tumor cells | 2018 | Available exclusively in the US | Created by Epic Sciences and marketed through a collaboration with Exact Sciences. |
| Oncotype DX Genomic Prostate Score | Prostate | Genomic test supporting treatment strategy for patients diagnosed with low to intermediate-risk prostate cancer | 2013 | Accessible in more than 90 countries |