🔬 Screening & Early Detection Products
| Product | Description | Medicare Reimbursement | Self-Pay Price | Patient Cost |
|---|---|---|---|---|
| Cologuard Flagship | Multi-target stool DNA test for colorectal cancer and precancerous polyps. 20M+ tests completed since 2014. Coverage every 3 years, ages 45-85. | $508 | Not disclosed | 96% pay $0 Zero cost-sharing Medicare Part B |
| Cologuard Plus New 2025 | Next-generation version: 95% cancer detection (vs 92%), 94% specificity (vs 87%). 40% reduction in false positives. FDA approved Oct 2024. Launched March 31, 2025. | $592 +16% vs original | $790 | Medicare: $0 Most insured: $0 35-40% of volumes expected to transition in 2025 |
| Cancerguard Sept 2025 | Blood-based multi-cancer early detection test. Detects 19+ cancer types with 68% sensitivity for deadliest cancers and 97.4% specificity. Ages 50-84. | No coverage yet (negotiations in progress) |
$689 | Self-pay: $689 Can use FSA/HSA Imaging Reimbursement Program: up to $6,000 for follow-up imaging |
| Cancerguard EX H2 2025 | Enhanced multi-cancer detection test launching second half 2025. | Pricing not yet disclosed | ||
| Riskguard Feb 2024 | Hereditary cancer risk assessment analyzing 59 genes across 11 cancer types. Blood, saliva, or buccal swab samples. | Covered (rate not disclosed) |
Not disclosed | Medicare: $0 when criteria met Covered by Aetna, Anthem, Cigna, Humana, UnitedHealthcare |
🎯 Precision Oncology & Treatment Guidance
| Product | Description | Medicare Reimbursement | Estimated Price | Patient Cost |
|---|---|---|---|---|
| Oncotype DX Breast Gold Standard | 21-gene assay for HR+/HER2- early-stage invasive breast cancer. Predicts 10-year recurrence risk and chemotherapy benefit. 1M+ patients tested worldwide over 20 years. | ~$3,416 (CPT 81519) |
$3,454 (GSA Schedule) |
86% pay $0 91% pay <$100 Medicare fee-for-service: $0 when criteria met |
| Oncotype DX DCIS | 12-gene expression profiling for ductal carcinoma in situ (non-invasive breast cancer). | ~$3,400 | ~$3,400 | Similar to Breast test |
| Oncotype DX Colon | Recurrence score test for Stage II colon cancer to determine adjuvant chemotherapy need. | Covered | ~$3,400 | Similar coverage profile |
| OncoExTra Feb 2023 | Comprehensive genomic profiling across ~20,000 genes and 169 introns. NGS for advanced, metastatic, refractory, relapsed, or recurrent solid tumors. Identifies targetable mutations and clinical trial matches. | Covered for NGS component | Not disclosed (Est. ~$3,500 based on comparables) |
98% pay $0 for NGS component (2024 data) IHC add-ons may have cost-sharing |
| Oncodetect April 2025 | Tumor-informed molecular residual disease (MRD) test tracking up to 200 ctDNA variants. Detects residual cancer after treatment. Serial use over 5 years for Stage II, III, resectable Stage IV CRC. | Medicare coverage approved July 9, 2025 Rate not disclosed |
~$3,000 (analyst estimate) |
Medicare fee-for-service: $0 Commercial coverage expanding Addressable: 150K+ new CRC cases annually |
🧬 PreventionGenetics Comprehensive Genetic Testing
| Test Category | Details | Standard Price | Additional Info |
|---|---|---|---|
| Hereditary Cancer Panels | 55 genes across 11+ cancer types: breast, ovarian, uterine, prostate, colorectal, pancreatic, gastric, renal, lung, endocrine, skin | $540-$590 | Medicare: covered with $0 cost when criteria met Commercial insurance widely covered |
| PGxome Whole Exome Sequencing | Comprehensive whole exome sequencing test | Standard $990; Rapid $2,290 | CNV analysis included Free reflex testing to remaining genes Rapid: 14-day expedited turnaround |
| Standard Test Menu | 5,000+ genetic tests covering nearly all clinically relevant genes. CLIA-certified, CAP-accredited lab with 25+ PhD geneticists. | $990 or less (most tests) | Turnaround: 3 weeks standard, 2 weeks STAT STAT fee: +25% Custom panels: variable pricing |
Sponsored No-Cost Testing Programs:
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💰 Patient Financial Assistance Program
Income Eligibility: Up to 400% Federal Poverty Level - More generous than most programs (200-300% FPL)
| Household Size | 2025 Income Threshold (400% FPL) | Benefit |
|---|---|---|
| 1 person | $62,600 | Potentially $0 out-of-pocket costs across all Exact Sciences products Automatic qualification if enrolled in: Medicaid, SNAP, SSI, Home Energy Assistance, or similar programs |
| 2 people | $84,600 | |
| 3 people | $106,600 | |
| 4 people | $128,600 | |
| Additional person | +$22,000 each |
Application Methods:
- Online: Complete Patient Assistance Estimator at exactsciences.com
- Phone: 866-267-2322 (Oncotype) or 844-870-8870 (Cologuard)
- Email: help@exactsciences.com
- Fax: 844-870-8875
- Mail: ES Labs, Madison, Wisconsin
Required Documentation: Income verification or proof of government program enrollment. Forms available in English and Spanish.
✨ Key Highlights
🎯 Market Leadership
20 years as gold standard for breast cancer testing (Oncotype DX)
18M+ Cologuard tests completed since 2014
20 years as gold standard for breast cancer testing (Oncotype DX)
18M+ Cologuard tests completed since 2014
📈 2025 Revenue Guidance
$3.13-3.17 billion (continued double-digit growth)
15% CAGR target through 2027
$3.13-3.17 billion (continued double-digit growth)
15% CAGR target through 2027
🌟 Product Innovations
3 major launches in 2025: Cologuard Plus, Oncodetect, Cancerguard
40% reduction in false positives with Cologuard Plus
3 major launches in 2025: Cologuard Plus, Oncodetect, Cancerguard
40% reduction in false positives with Cologuard Plus
🏥 Provider Network
300,000+ healthcare provider customers
200+ large U.S. health systems
300,000+ healthcare provider customers
200+ large U.S. health systems