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January 25, 2025

Advancing the future of cancer management

Insights from the Alpha-CORRECT clinical validation study

At Exact Sciences, we are developing leading-edge cancer diagnostics to improve patient outcomes. Our latest innovation comes from the Alpha-CORRECT clinical validation study, a landmark study that underscores our commitment to innovation in the detection of molecular residual disease (MRD) in colorectal cancer. This week, we shared our findings at the annual ASCO Gastrointestinal Cancers Symposium conference and concurrently published them in the Journal of Surgical Oncology.

Improving Cancer Monitoring with the OncodetectTM Test

The Alpha-CORRECT study is an important milestone in our efforts to guide personalized cancer testing. This study focused on stage III colorectal cancer patients and utilized the OncodetectTM molecular residual disease (MRD) test to detect circulating tumor DNA (ctDNA) in a patient’s blood. The findings from this study further validate the transformative capabilities of MRD testing in monitoring cancer patients after treatment.

Key Findings and Clinical Implications

  • Identifying high-risk patients: Colorectal cancer patients with a positive Oncodetect test after surgery or chemotherapy had a higher risk of cancer recurrence, while those with a negative test had a significantly lower risk. This insight could help clinicians to better stratify patients based on their recurrence risk and tailor treatment and follow-up care accordingly1.
  • Surveillance and early detection of recurrence: The Alpha-CORRECT study showed that patients with positive ctDNA results during surveillance were 50 times more likely to have their cancer come back than those with negative results1. The test detected recurrence months earlier than standard methods, highlighting the importance of regular testing for early detection for recurrence1.

Impact on Clinical Practice

The Alpha-CORRECT study findings highlight the clinical validity of the Oncodetect test in providing a precise assessment of a patient’s risk of cancer recurrence. For instance, patients with ctDNA detected post-surgery had a recurrence rate nearly 10 times higher than those without detectable ctDNA. Similarly, patients with ctDNA detected after chemotherapy had a recurrence rate nearly 17 times higher. Conversely, only about 2% of patients with persistently negative ctDNA tests during Alpha-CORRECT — one of the longest MRD surveillance studies to date — experienced cancer recurrence.

The Oncodetect test aims to give health care professionals deeper insights into a patient's MRD status over time, facilitating more informed decision-making and personalized treatment plans.

A New Era in Cancer Care

The Alpha-CORRECT study is the first published study showing the potential for Oncodetect to empower doctors to deliver more impactful care for their patients.

As we continue to innovate, this study reinforces our dedication to transforming cancer detection and improving lives. Stay tuned as we build on this success, share additional clinical evidence and work toward a future where cancer is caught earlier and managed with precision.

 


1. Diergaarde B, et al. Circulating Tumor DNA as a Marker of Recurrence Risk in Stage III Colorectal Cancer: The α-Correct Study. Journal of Surgical Oncology. January 25, 2025.