Breakthrough Clinical Results
Exact Sciences announced the presentation of ten abstracts at the 2025 ASCO Annual Meeting, showcasing new data on its Oncodetect MRD test, multi-cancer early detection (MCED) testing, Oncotype DX Breast Recurrence Score test, and Cologuard test. The presentations highlight advancements in early cancer detection and precision oncology. New data strengthens the Oncodetect test's ability to detect cancer recurrence, while MCED modeling suggests significant potential for reducing late-stage cancer incidence and mortality. Exact Sciences is preparing to launch its Cancerguard EX MCED test in the second half of 2025. Real-world evidence continues to support the Cologuard and Oncotype DX tests.
Key Highlights
- Presentation of ten abstracts at ASCO 2025 showcasing new data on various cancer tests.
- New data strengthens the Oncodetect MRD test's role in guiding treatment decisions for colorectal cancer.
- Modeling study suggests MCED testing could significantly reduce late-stage cancer incidence and mortality.
- Exact Sciences prepares to launch its Cancerguard EX MCED LDT in the second half of 2025.
Incidence and Prevalence
Global Colorectal Cancer Statistics
Research on colorectal cancer (CRC) has been conducted across various populations worldwide, though specific regional patterns emerge from available data.
A comprehensive analysis of 5,071 cancer cases included 451 colorectal cancer cases from a Women's Health Study, providing valuable data on CRC incidence in this specific population.
In Italy, researchers documented 1,953 colorectal cancer cases compared with 4,154 controls in an epidemiological investigation. Further regional insights from North-eastern Italy revealed significant variations in incidence based on country of origin. The lowest incidence rate ratios (IRR) for colorectal cancer were observed in males from South-Central America (IRR 0.19, 95%CI 0.09-0.44) and in females from Asia (IRR 0.32, 95%CI 0.18-0.70), suggesting important geographic and ethnic variations in CRC risk.
A large Nordic study examining occupational differences in cancer incidence found that colon cancer demonstrated the smallest relative variation in incidence between different occupational categories, indicating that socioeconomic factors may play a less significant role in colon cancer development compared to other malignancies.
The Surveillance, Epidemiology, and End Results (SEER) database documented 440,144 colorectal cancer cases from 1975 to 2012 in the United States, representing a substantial longitudinal dataset for understanding CRC trends in the American population.
Regarding molecular characteristics, a meta-analysis determined that the overall microsatellite instability (MSI) frequency among colorectal cancers was 17% (95%CI: 15%-19%). This genetic feature has important implications for treatment approaches and prognosis in CRC patients.
These findings highlight the complex regional variations in colorectal cancer incidence across different populations, with notable differences based on geographic origin, gender, and genetic characteristics.
Key Unmet Needs and Targeted Populations in Colorectal Cancer Research
Unmet Needs in Colorectal Cancer
Colorectal cancer is one of the most common malignancies causing the majority of cancer-related deaths, with high incidence and mortality rates in the digestive system. There is an urgent need to develop new anticancer modalities and to identify and develop new molecular targets for colorectal cancer treatment.
Recent publications highlight several critical unmet needs:
- Need for accurate biomarkers that can identify persons at increased risk of colorectal cancer, as current biomarkers cannot accurately identify high-risk or low-risk individuals
- Early detection challenges as some patients have advanced disease at diagnosis with only 8% five-year survival rate compared to early-stage patients who can receive curative treatment
- Need for new treatments to supplement currently available drugs to further improve survival in metastatic colorectal cancer (mCRC), particularly as it remains incurable in metastatic stage
- Need for improved treatment for patients with BRAF mutant colorectal cancers, as current responses are brief and progression is common
- Need for PI3K inhibitors, as none have proven successful yet in colorectal cancer
- Need for optimal sequence of treatments for heavily pretreated mCRC patients
- Need for more predictors of cetuximab efficacy to further improve precise treatment
- Need for patient-centered survivorship programs to address psychosocial and symptomatic needs of survivors
- Need for better management of treatment-related problems, especially for rectal cancer patients who have significantly more unmet needs than colon cancer patients
- Information provision gaps with 73% of patients reporting low satisfaction with amount of information received
- Decision-making challenges with 64% of patients having low decision self-efficacy and 80% experiencing decisional conflict regarding lifestyle changes
- Low rates of behavior modification among cancer patients after diagnosis
Targeted Populations
Research and treatment efforts are focusing on several key populations:
- American Indian and Alaska Native (AI/AN) populations who have 41% higher colorectal cancer incidence than White persons
- Regions with significant disparities, with incidence rates ranging from 34.4 per 100,000 in the East to 96.1 per 100,000 in Alaska
- Younger adults under 50 years old who show rising incidence rates in both AI/AN and White populations
- Patients with specific molecular alterations including BRAF and PIK3CA mutations
- Patients with defect Mismatch repair (dMMR) who show high complete response rates to immunotherapy
- Patients with proficient MMR (pMMR) who may also benefit from immunotherapy
- Patients with wild-type KRAS who can benefit from EGFR antibodies (cetuximab and panitumumab)
- Heavily pretreated mCRC patients who progressed on standard therapies
- Patients with operable stage I-III disease who might benefit from neoadjuvant immunotherapy
- Colorectal cancer survivors requiring comprehensive survivorship care
- Patients with rectal cancer who have more unmet needs than colon cancer patients
- Populations with higher rates of late-stage diagnoses, particularly AI/AN persons compared to White persons
There is a critical need for enhanced screening efforts and culturally appropriate interventions, especially in regions where rates are increasing.
Drug used in other indications
Based on the provided context, there is no information available about a product, test, or treatment called "Oncodetect" being trialed for colorectal cancer or any other indications. The context does not contain any references to "Oncodetect" in any capacity, nor does it provide information about intervention models for trials related to this specific product.
The context instead discusses various other cancer treatments and their associated trials, but none mentioning Oncodetect.