Abbott Park, Illinois, U.S., October 26, 2026
Abbott has announced the commercial availability of its next-generation OncoDetect® molecular residual disease (MRD) test, a personalized cancer diagnostic designed to detect traces of cancer during and after treatment. The test combines whole-genome sequencing (WGS) with MAESTRO technology to identify extremely low levels of circulating tumor DNA (ctDNA) in blood samples. This approach aims to provide healthcare professionals with additional molecular information about residual disease, treatment response, and the risk of cancer recurrence. The launch marks an advancement in precision oncology, where genomic information is increasingly used to support individualized cancer management. By tracking genetic changes specific to an individual patient’s tumor, the OncoDetect test is designed to identify cancer-associated signals that may remain after surgery or other treatments, even when those signals are difficult to detect. Abbott estimates that more than three million U.S. patients with solid tumors could potentially benefit from MRD testing, based on its internal assessment of addressable patient populations.
Whole-Genome Sequencing Expands Cancer DNA Detection
The next-generation OncoDetect test uses a tumor-informed testing approach, beginning with a sample of the patient’s tumor, typically obtained through a biopsy or surgery. The tumor sample is analyzed to identify genetic variants associated with that particular cancer. A subsequent blood test then searches for those same variants in circulating tumor DNA, providing a personalized molecular profile that can be monitored over time. According to Abbott, the updated test can track up to 5,000 patient-specific genetic variants, compared with up to 200 in its first-generation version. The expanded number of tracked variants creates more opportunities to identify residual cancer signals when tumor DNA is present at very low concentrations. The test incorporates MAESTRO technology, developed at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard and enhanced by Abbott for this application. The technology enriches tumor-derived DNA from blood samples before sequencing, helping distinguish cancer-associated signals from the much larger background of non-tumor DNA. Under high-end input conditions, Abbott reports a limit of detection below one part per million and analytical specificity above 99%. These are analytical performance characteristics, not a guarantee that the test will detect every recurrence or predict an individual patient’s outcome.
Clinical Evidence Supports MRD Testing Potential
Abbott reports that clinical investigations are evaluating the next-generation OncoDetect test across multiple solid tumor types. In patients with locally advanced esophageal cancer who subsequently experienced recurrence, longitudinal testing reportedly detected circulating tumor DNA before recurrence in all 14 patients studied. In the PARTNER triple-negative breast cancer study, a single post-surgery blood draw identified 90% of patients who later experienced distant recurrence within five years, according to the company’s reported findings. Abbott also highlighted Beta-CORRECT study data presented at the 2026 European Society for Medical Oncology Congress, reporting a 30-percentage-point absolute improvement in sensitivity for recurrence within two years compared with the first-generation test at a single postsurgical time point in patients with stage II–IV colorectal cancer. These findings suggest that improved molecular detection may help clinicians identify patients with evidence of residual disease and better understand recurrence risk. However, the results come from specific studies and populations, and further evidence is needed to determine how MRD testing should influence treatment decisions across different cancers. A positive MRD result does not independently establish the location or extent of cancer, while a negative result cannot completely exclude residual disease.
Advertisement
Advancing Precision Oncology and Patient Monitoring
The commercial launch expands Abbott’s cancer diagnostics portfolio, which includes genomic testing, recurrence-risk assessment, hereditary cancer testing, and cancer screening technologies. The company is continuing clinical research through more than 20 ongoing studies involving the next-generation OncoDetect test, alongside academic collaborations and real-world investigations. Abbott is also working to broaden patient access through payer coverage initiatives and international expansion. The test is available for patients with solid tumors through healthcare provider orders, with results intended to complement other clinical information during cancer management. Importantly, Abbott states that the test has not been cleared or approved by the U.S. Food and Drug Administration (FDA) and is performed by a laboratory certified under Clinical Laboratory Improvement Amendments (CLIA) requirements for high-complexity testing. Its performance characteristics may not apply to tumor types outside its clinical validation. Overall, the launch highlights the growing role of molecular residual disease testing, genomic sequencing, and personalized diagnostics in oncology. Continued clinical validation and evidence on how testing affects patient outcomes will be important in establishing its role in routine cancer care.
Source: Abbott press release
