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Abbott presents new ESMO data showing 30-percent absolute improvement in sensitivity with the whole-genome sequencing Oncodetect® test in colorectal cancer

Among 157 patients tested with both versions, whole-genome sequencing identified 15 additional patients with circulating tumor DNA.

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Abbott (ABT) presented Beta-CORRECT study results showing improved colorectal cancer recurrence detection with its whole-genome sequencing Oncodetect blood test.

The study analyzed post-surgical samples from 279 patients, predominantly with stage II and III disease. A single blood draw approximately one month after surgery achieved 72.2% sensitivity for recurrence within two years, versus 42.2% with the whole-exome sequencing test—a 30-percent absolute improvement. Sensitivity measures how often a test identifies patients who experience recurrence. Patients with detectable circulating tumor DNA, or tumor DNA in blood, had a 10.6-fold higher recurrence risk than those without detectable tumor DNA. Two-year disease-free survival was 36.2% versus 92.3%, respectively.

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Positive

  • Moderate pointWhole-genome Oncodetect achieved 72.2% sensitivity for recurrence within two years versus 42.2% with whole-exome testing.
  • Moderate pointDetectable post-surgical tumor DNA identified 10.6-fold higher recurrence risk; two-year disease-free survival was 36.2% versus 92.3%.
  • Minor pointPaired testing in 157 patients detected all 29 whole-exome-positive cases plus 15 additional cases.
  • Minor pointStage II patients with detectable post-surgical tumor DNA had approximately 31-fold higher recurrence risk than test-negative patients.

Negative

  • None.

News Explained

The results add low-level detections and stage II risk evidence, but Oncodetect remains unapproved by the FDA.

Abbott presented new Beta-CORRECT results at ESMO; its Oncodetect test has not been cleared or approved by the U.S. FDA.

Among 157 patients tested with both methods, the whole-genome sequencing test detected ctDNA in 15 patients beyond the 29 identified by the whole-exome sequencing test; all 15 additional detections were below 20 ppm, including 14 below 10 ppm.

In stage II patients, detectable post-surgical ctDNA was associated with an approximately 31-fold higher recurrence risk than undetectable ctDNA; 2.8% of those with undetectable ctDNA had recurrence within two years.

Abbott says further patient follow-up and data from subsequent testing time points are expected to provide more information about the relationship between MRD, adjuvant therapy and recurrence risk over time.

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  • Beta-CORRECT study shows a 10.6-fold higher risk of recurrence, reinforcing the prognostic value of molecular residual disease (MRD) testing1
  • Building on its leadership in colorectal cancer screening with the Cologuard® test, Abbott is connecting innovations across the cancer care continuum, from early detection to post-treatment monitoring

ABBOTT PARK, Ill., Oct. 23, 2026 /PRNewswire/ -- For patients with colorectal cancer, surgery can remove visible cancer, but it can be difficult to know whether minute traces of the disease remain. Abbott (NYSE: ABT) today announced new Beta-CORRECT data presented at the European Society for Medical Oncology (ESMO) Congress showing that the whole-genome sequencing (WGS)-based Oncodetect® molecular residual disease (MRD) test achieved a 30-percent absolute improvement in sensitivity for colorectal cancer recurrence within two years of surgery, compared with the whole-exome sequencing (WES) Oncodetect test, using a single post-surgery blood draw.1

For more than 12 years, Abbott's cancer diagnostics business has helped expand access to colorectal cancer screening through Cologuard®. Together with Oncodetect, these innovations reflect Abbott's connected approach to cancer care, from early detection to monitoring for recurrence after treatment.

Conducted in collaboration with Dr. Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East in Japan, Beta-CORRECT is the first clinical validation study of the WGS Oncodetect test in patients with stage II, III and resectable stage IV colorectal cancer. The test tracks up to 5,000 DNA variants unique to each patient's tumor, expanding opportunities to detect residual disease when very little cancer DNA is present.1 The study analyzed post-surgical samples from 279 patients, predominantly with stage II and III colorectal cancer.1

Key findings from Beta-CORRECT:

  • Improved sensitivity: A single blood test taken approximately one month after surgery using the WGS test achieved 72.2% sensitivity for recurrence within two years, compared with 42.2% for the WES test, a 30-percent absolute improvement.1
  • Additional ctDNA detection: Among 157 patients tested post-surgery with both tests, the WGS test detected ctDNA in all 29 patients in whom the WES test identified, plus 15 additional patients. All additional detections were at levels below 20 parts per million (ppm), including 14 that were below 10 ppm.1
  • Strong prognostic value: Patients with detectable ctDNA after surgery had a 10.6-fold higher risk of recurrence than ctDNA-negative patients. Two-year disease-free survival rates were 36.2% versus 92.3%, respectively.1
  • Stage II findings: Patients with detectable post-surgical ctDNA had approximately 31-fold higher recurrence risk compared to those who were ctDNA negative. Only 2.8% of stage II patients with undetectable ctDNA experienced recurrence within two years.2

"Beta-CORRECT adds important clinical evidence supporting the prognostic value of highly sensitive MRD testing in colorectal cancer," said Dr. Takayuki Yoshino, MD, PhD, National Cancer Center Hospital East and principal investigator of the Beta-CORRECT study. "The ability to identify additional patients with detectable ctDNA after surgery may help refine recurrence risk assessment beyond traditional clinical factors. Continued research will help determine how these findings can best inform patient management."

"These findings reinforce why sensitivity matters in MRD testing, particularly after surgery when ctDNA can be difficult to detect," said Dr. Rick Baehner, divisional vice president, chief medical officer, precision oncology, Abbott's cancer diagnostics business. "By identifying additional patients with residual disease, we can provide physicians with important molecular information about recurrence risk at a critical point in care."

Detecting ctDNA after surgery was the strongest predictor of cancer recurrence among the factors studied, providing important information about a patient's risk beyond traditional clinical measures. Additional patient follow-up and longitudinal data from subsequent testing time points are expected to provide further insights into the relationship between MRD, adjuvant therapy and recurrence risk over time.

The findings were presented at ESMO 2026 in poster 4426P, Validation of the ultrasensitive tumor-informed WGS MAESTRO MRD assay in β-CORRECT.

About the Oncodetect® test
The next-generation Oncodetect® test is a whole-genome sequencing-based, tumor-informed molecular residual disease (MRD) test designed to provide a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. The test analyzes circulating tumor DNA (ctDNA) shed into the bloodstream by tumors, offering insights into changes in ctDNA levels over time. This quantitative assessment of ctDNA (measured as MTM/mL) helps healthcare providers better understand a patient's MRD status and make informed treatment decisions.  

The Oncodetect® test was developed, and its performance characteristics determined by Genomic Health, Inc. Performance characteristics may not apply in tumor types not included in this test's clinical validation. The test has not been cleared or approved by the US Food and Drug Administration. The test is performed at Genomic Health Inc. The Genomic Health Inc. lab performing this test is certified under CLIA regulations and qualified to perform high-complexity clinical laboratory testing. 

About Abbott: 
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, and on LinkedIn, Facebook, Instagram, X and YouTube. 

  1. Hashimoto, T. et al. Validation of the ultrasensitive tumor-informed WGS MAESTRO MRD assay in β-CORRECT. Poster 4426P presented at ESMO 2026; October 23-27, 2026; Madrid, Spain.
  2. Data on File – Additional Beta-CORRECT WGS analysis performed. October 2026.

Cision View original content:https://www.prnewswire.com/news-releases/abbott-presents-new-esmo-data-showing-30-percent-absolute-improvement-in-sensitivity-with-the-whole-genome-sequencing-oncodetect-test-in-colorectal-cancer-302917569.html

SOURCE Abbott

FAQ

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How much did Abbott's whole-genome Oncodetect test improve colorectal cancer recurrence detection?

The whole-genome test achieved 72.2% sensitivity for recurrence within two years, compared with 42.2% for the whole-exome test. That represents a 30-percent absolute improvement using a single blood draw approximately one month after surgery.

What did Abbott's Beta-CORRECT study show about recurrence risk?

Patients with detectable circulating tumor DNA after surgery had a 10.6-fold higher risk of recurrence than patients without detectable tumor DNA. Two-year disease-free survival rates were 36.2% and 92.3%, respectively.

What did Abbott's Beta-CORRECT study find in stage II colorectal cancer?

Stage II patients with detectable post-surgical circulating tumor DNA had approximately 31-fold higher recurrence risk than those without detectable tumor DNA. Only 2.8% of stage II patients with undetectable tumor DNA experienced recurrence within two years.

Is Abbott's Oncodetect test FDA approved?

The Oncodetect test has not been cleared or approved by the US Food and Drug Administration. It is performed at Genomic Health, whose laboratory is certified under CLIA regulations and qualified to perform high-complexity clinical laboratory testing.

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