Exact Sciences - Oncotype DX GPS Prostate Cancer Business

What Exact Sciences - Oncotype DX GPS Prostate Cancer Business does

Exact Sciences Corporation, now operating as part of Abbott following an acquisition announced November 20, 2025, is a publicly traded (formerly NASDAQ: EXAS) cancer diagnostics company headquartered at 5505 Endeavor Lane in Madison, Wisconsin. The company sells a portfolio of laboratory-developed and FDA-approved diagnostic tests spanning the full cancer care continuum: Cologuard and Cologuard Plus stool DNA tests for colorectal cancer screening, the Cancerguard multi-cancer early detection (MCED) blood test launched in September 2025, Oncotype DX genomic tests for breast, colon, and prostate cancer (the GPS prostate test being the focus of this analysis), the Oncodetect molecular residual disease (MRD) test, the OncoExTra therapy selection test, Oncoguard Liver for hepatocellular carcinoma surveillance, and the Riskguard hereditary cancer test. Core technology rests on multi-target stool DNA analysis with methylation and mutation biomarkers, circulating tumor DNA (ctDNA) for MRD, DNA methylation plus protein biomarker panels for MCED, and tumor tissue genomic profiling for treatment guidance, all processed in CLIA-certified laboratories in Madison, San Diego, and Redwood City.

The company generates revenue through per-test laboratory service fees reimbursed primarily by Medicare, Medicare Advantage, and commercial insurance under established coverage determinations. Distribution is sales-led via an enterprise field sales force that targets healthcare providers, health systems, and payer organizations; the ExactNexus digital platform connects ordering workflows across providers, payers, and patients. End customers include adults 45+ eligible for routine cancer screening, oncology and urology specialists using genomic recurrence scores for chemotherapy and treatment decisions, health systems running population screening programs, and payers covering Cologuard on a three-year cadence. Strategic assets include 60+ granted US patents covering Cologuard chemistry, FDA approvals on the screening franchise, peer-reviewed clinical evidence from the DeeP-C and BLUE-C pivotal trials published in the New England Journal of Medicine, co-development relationships with Mayo Clinic and Johns Hopkins, and a US/global commercial footprint spanning the Americas, Europe, EMEA, and Asia Pacific.

Name

Exact Sciences - Oncotype DX GPS Prostate Cancer Business

Legal name

Exact Sciences Corporation

Website

https://exactsciences.com

Company type

Public

Founded year

1995

Operating status

Acquired

Headcount range

5,001–10,000 employees

Short description

Exact Sciences (now part of Abbott) sells FDA-approved and laboratory-developed cancer diagnostic tests — including Cologuard stool DNA screening, Oncotype DX genomic tests for breast/colon/prostate, Oncodetect MRD, and Cancerguard MCED — to providers, health systems, and payers via reimbursed laboratory services.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics and Precision Oncology Testing

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH)

Keywords

• Genomic cancer diagnostics
• Prostate cancer testing
• Precision oncology tests
• Molecular residual disease
• Hereditary cancer screening

Headquarters

HQ city

Madison

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Laboratory Testing Services: Exact Sciences generates revenue through laboratory testing services performed at their CLIA-certified facilities. Tests are ordered by healthcare providers and processed in company labs with results delivered to physicians.
2. Cancer Screening Tests: Revenue from Cologuard and Cologuard Plus stool-based colorectal cancer screening tests, and Cancerguard multi-cancer early detection blood test.
3. Precision Oncology Tests: Oncotype DX tests (Breast Recurrence Score, Breast DCIS Score, Colon Recurrence Score), Oncodetect MRD test, OncoExTra therapy selection test, and Riskguard hereditary cancer test generate revenue through laboratory service fees.
4. Payer Reimbursement: Tests are covered by Medicare, Medicare Advantage, and commercial insurance. Medicare coverage established for Cologuard, Oncotype DX tests, and Oncodetect in colorectal cancer. Patient Assistance Program supports access for uninsured/underinsured.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

Exact Sciences sells a portfolio of FDA-approved genomic and molecular cancer diagnostic tests, with the Oncotype DX GPS (Genomic Prostate Score) test providing a genomic recurrence and aggressiveness score from prostate tumor tissue to help urologists and patients decide between active surveillance and immediate treatment. The portfolio is rounded out by Oncotype DX Breast Recurrence Score and Colon Recurrence Score treatment-guidance tests, Cologuard and Cologuard Plus non-invasive colorectal cancer screening, Cancerguard multi-cancer early detection, Oncodetect ctDNA-based MRD monitoring, OncoExTra therapy selection, Oncoguard Liver, and Riskguard hereditary cancer testing, all processed at CLIA-certified Exact Sciences laboratories.

Differentiator

Problem solved

Functional benefit

Brands

• Cancerguard: Multi-cancer early detection blood test that helps detect 50+ cancer types
• Cologuard
• Cologuard Plus
• Oncotype DX
• Oncodetect
• OncoExTra
• Oncoguard Liver
• Riskguard
• Exact Oncology
• ExactNexus

Products and services

• Oncotype DX GPS (Genomic Prostate Score)

Quantifiable outcome

• Cologuard detected 92% of colorectal cancers vs 74% for FIT; 42% of advanced precancerous lesions vs 24% for FIT
• +4 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Eleven partnerships are on record, tiered core and flagship.

• FreenomecoreOEM/ Whitelabel/ Licensing Partner · 6 August 2025Exclusive license agreement for Freenome's blood-based colorectal cancer screening tests. This expands Exact Sciences' portfolio of CRC screening options and adds blood-based testing capabilities.
• Mayo ClinicflagshipStrategic or Co-development Partner · 1 January 2009Long-standing collaborative relationship with Mayo Clinic scientists and clinicians in Rochester, Minnesota. Kevin Conroy and Dr. Graham Lidgard of Exact Sciences met with Dr. David Ahlquist of Mayo Clinic in 2009 to discuss a novel approach for colorectal cancer screening. Together they invented Cologuard, the first and only FDA-approved stool DNA colorectal cancer screening test. Also established broad R&D collaboration focused on identifying biomarkers for 15 deadliest cancers.
• Johns Hopkins UniversityflagshipStrategic or Co-development PartnerCollaboration stems from acquisition of Thrive Earlier Detection. Thrive's innovative multi-cancer screening technology was pioneered by researchers from Johns Hopkins University School of Medicine including Bert Vogelstein (pioneer in cancer genomics), Dr. Nickolas Papadopoulos (expert in cancer diagnostics), and Kenneth W. Kinzler (expert on molecular analysis of human cancer).
• TGen (City of Hope)coreStrategic or Co-development PartnerTGen became part of City of Hope in 2016 to accelerate translating research discoveries into patient cures. City of Hope is an NCI-designated comprehensive cancer center and founding member of the National Comprehensive Cancer Network, making it a national leader in cancer research and treatment.
• HumanacoreChannel Partner/ Reseller/ DistributorExpanded colorectal cancer screening partnership. Cologuard Plus test became available in-network for Humana members August 2025. Partnership provides broader access to next-generation colorectal cancer screening for Humana's patient population.
• National Cancer InstituteflagshipStrategic or Co-development PartnerExact Sciences laboratory and OncoExTra test selected by NCI for ComboMATCH clinical trials. This partnership enables advanced solid tumor patients to access comprehensive genomic profiling through the national clinical trial network.
• Flatiron HealthcoreTechnology or IntegrationPartnership to advance clinical evidence generation for molecular residual disease testing. Collaboration leverages real-world data and clinical evidence to improve cancer care and support evidence-based medicine.
• PGA Tour ChampionscoreGTM or Marketing PartnerCologuard Classic sponsorship extended through 2027. Partnership includes PGA Tour Champions tournament, celebrity golfer participation, and community events to raise colon cancer awareness and promote screening.
• NSABP FoundationcoreStrategic or Co-development PartnerPartnership with NSABP Foundation and German Breast Group to present results for Oncodetect MRD test in early triple-negative breast cancer at SABCS 2025.
• National Minority Quality ForumcoreStrategic or Co-development PartnerCollaboration to improve cancer screening accessibility, including examining cancer incidence in Flint, Michigan and hosting community cancer screening and health fairs.
• Federally Qualified Health CenterscoreGTM or Marketing PartnerPartnership with FQHCs focused on underserved populations. Collaborations include creating assistance programs, engaging patients in their preferred language, and understanding health literacy to better meet community needs.

Scale indicators10 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Myriad Genetics: Direct competitor in prostate cancer genomics with Prolaris test, which provides cell cycle progression score for prostate cancer prognosis. Competes head-to-head with Oncotype DX GPS in the active surveillance and treatment decision-making market.
• Guardant Health: Direct competitor in liquid biopsy and oncology diagnostics with Guardant360 (tumor profiling) and Reveal (MRD). Competes with Exact Sciences' Oncodetect (MRD) and broader precision oncology portfolio across multiple cancer types including prostate.
• Caris Life Sciences: Direct competitor in oncology molecular profiling (Caris Molecular Intelligence) and MRD (Caris Assure). Competes with Exact Sciences' OncoExTra for therapy selection and Oncodetect for MRD monitoring across solid tumors.
• Foundation Medicine (Roche): Direct competitor in comprehensive genomic profiling for therapy selection with FoundationOne CDx. Competes with Exact Sciences' OncoExTra for advanced solid tumor therapy guidance and is used in similar clinical trial settings (e.g., NCI MATCH trials).
• Natera: Direct competitor in oncology MRD testing with Signatera tumor-informed MRD assay. Competes with Exact Sciences' Oncodetect for monitoring cancer recurrence and treatment response, with significant overlap in colorectal and other solid tumor indications.
• MDxHealth: Direct competitor with SelectMDx and ConfirmMDx prostate cancer diagnostics. Operates in the same urological genomics market as Oncotype DX GPS, focused on biopsy decision-making and prostate cancer risk stratification.
• Veracyte: Acquired Decipher Biosciences in 2021, which provides the Decipher genomic classifier for prostate cancer. Directly competes with Oncotype DX GPS in urological genomics, with complementary positioning in genomic prostate testing and active surveillance.
• GRAIL: Direct competitor in multi-cancer early detection with Galleri test. Competes head-to-head with Exact Sciences' Cancerguard MCED test for early cancer screening using blood-based methylation and biomarker approaches.

Emerging players

• Freenome: Emerging competitor in blood-based colorectal cancer screening. Exact Sciences has an exclusive license for Freenome's blood-based CRC screening tests (announced August 2025), making Freenome both a potential partner and a partial competitor in MCED-adjacent markets.
• Tempus AI: Emerging player in precision oncology with xT (tumor profiling) and xR (RNA) assays. Increasing overlap with Exact Sciences' precision oncology portfolio, though still building scale in MRD and hereditary cancer testing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xtwitter.com/exactsciences
• Facebookfacebook.com/pages/Exact-Sciences/385857408151799
• LinkedInlinkedin.com/company/exact-sciences

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Exact Sciences - Oncotype DX GPS Prostate Cancer Business