Abbott Park, Illinois, USA, October 23, 2026
Abbott has presented new clinical data showing that its whole-genome sequencing-based Oncodetect® test achieved a 30-percentage-point improvement in sensitivity for detecting colorectal cancer recurrence compared with its whole-exome sequencing-based version. The findings from the Beta-CORRECT study were presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. The study evaluated the test’s ability to detect molecular residual disease (MRD), which refers to small amounts of cancer that may remain in the body after surgery even when no visible disease is detected. Using a single blood sample collected approximately one month after surgery, the whole-genome sequencing test achieved 72.2% sensitivity for predicting recurrence within two years, compared with 42.2% for the whole-exome sequencing version. The results highlight the potential of advanced genomic testing to improve recurrence-risk assessment and support more personalized follow-up strategies for patients with colorectal cancer.
Whole-Genome Sequencing Improves Recurrence Detection
The Beta-CORRECT study was conducted in collaboration with researchers at Japan’s National Cancer Center Hospital East. It represents the first clinical validation study of Abbott’s whole-genome sequencing Oncodetect test in patients with stage II, stage III and surgically resectable stage IV colorectal cancer. The study analyzed postoperative samples from 279 patients, predominantly those with stage II and stage III disease. The test uses a tumor-informed approach, identifying genetic variants specific to each patient’s cancer and subsequently monitoring those variants in circulating tumor DNA (ctDNA) present in the bloodstream. By tracking up to 5,000 patient-specific DNA variants, the whole-genome sequencing approach is designed to detect extremely small quantities of cancer-derived DNA that may be missed by less comprehensive sequencing methods. In the reported comparison, a single postoperative blood draw produced a sensitivity of 72.2% for the whole-genome sequencing test, compared with 42.2% for the whole-exome sequencing test. This represents an absolute improvement of 30 percentage points. The findings suggest that broader genomic coverage may help identify more patients who are at risk of recurrence after apparently successful surgery. However, sensitivity measures the proportion of patients who experience recurrence and are correctly identified by the test; it does not mean that the test detects every recurrence or guarantees an improved clinical outcome.
Molecular Residual Disease Predicts Recurrence Risk
A major finding from Beta-CORRECT was the association between detectable postoperative ctDNA and subsequent cancer recurrence. Among 157 patients tested with both versions of Oncodetect, the whole-genome sequencing test identified ctDNA in all 29 patients detected by the whole-exome sequencing test, plus 15 additional patients whose cancer-derived DNA had not been detected by the earlier approach. All 15 additional detections occurred at low ctDNA concentrations below 20 parts per million, including 14 below 10 parts per million. These findings demonstrate the potential value of enhanced analytical sensitivity when cancer-derived DNA is present at very low levels after surgery. The study also found that patients with detectable postoperative ctDNA had a 10.6-fold higher risk of recurrence than patients whose tests were negative. Two-year disease-free survival was 36.2% among ctDNA-positive patients, compared with 92.3% among ctDNA-negative patients. In a subgroup analysis of stage II colorectal cancer, patients with detectable ctDNA had approximately 31 times the recurrence risk of those with undetectable ctDNA. These findings support MRD testing as a potentially valuable tool for refining recurrence-risk estimates beyond traditional clinical factors. Nevertheless, a negative result does not eliminate recurrence risk, and clinicians must interpret findings alongside pathology, imaging, treatment history and established clinical guidance.
Advertisement
Oncodetect Supports Precision Oncology Monitoring
Oncodetect is a personalized molecular diagnostic test designed to monitor residual cancer and changes in ctDNA over time. Unlike conventional imaging, which identifies structural abnormalities, MRD testing can provide molecular evidence of cancer that may be present at levels too small to visualize. Such information could eventually help clinicians identify patients who may benefit from closer monitoring or further evaluation of treatment options. Abbott is building on its existing colorectal cancer screening portfolio, including Cologuard®, while expanding its diagnostic capabilities into postoperative cancer monitoring. The company expects additional follow-up and longitudinal data to provide further information about the relationship between MRD status, adjuvant treatment and recurrence. Importantly, the Oncodetect test described in the announcement has not been cleared or approved by the U.S. FDA; it is performed by a laboratory certified under Clinical Laboratory Improvement Amendments (CLIA) regulations. The study establishes a promising performance signal, but further research is needed to determine how using the test to guide treatment decisions affects patient outcomes. The results nevertheless underscore the growing role of genomic sequencing and liquid biopsy technologies in precision oncology, with the potential to make cancer surveillance more individualized and evidence-driven.
Source: Abbott press release
