The updated test tracks up to 5,000 patient-specific variants and offers a 30-fold improvement in detection sensitivity to help identify cancer recurrence earlier.

Abbott announced the commercial availability of its next-generation Oncodetect molecular residual disease (MRD) test, a personalized, tumor-informed, whole-genome sequencing assay designed to identify traces of cancer during and after treatment. The diagnostic test detects circulating tumor DNA (ctDNA) in the blood of patients with solid tumors, providing clinical information to assess recurrence risk, evaluate therapy response, and guide postoperative management.

The test uses a tissue sample from a patient’s biopsy or surgical resection to identify unique DNA changes in the tumor and establish a molecular “fingerprint.” Clinicians then track those specific variants through routine blood samples drawn over time to monitor disease dynamics quantitatively, reported as MTM/mL.

“We’ve spent decades getting better at treating cancer once we find it. The next chapter is about understanding what may be happening at the molecular level during and after treatment,” says Dr Rick Baehner, divisional vice president, chief medical officer, precision oncology, Abbott’s cancer diagnostics business, in a release. “MRD represents an important evolution in precision oncology, helping move cancer care beyond waiting for signs of recurrence toward more informed decisions throughout a patient’s care. Our next-generation Oncodetect test reflects that evolution, bringing together whole-genome sequencing and MAESTRO technology to help detect residual disease when the molecular signal is extremely low.”

Ultrasensitive Variant Tracking and Enrichment

The assay transitions from the whole-exome sequencing utilized in Abbott’s first-generation test to whole-genome sequencing, expanding variant discovery from up to 200 variants to as many as 5,000 patient-specific variants.

Central to the platform is MAESTRO (minor allele enriched sequencing through recognition oligonucleotides), an enrichment technology originally developed at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard and further enhanced by Abbott. The MAESTRO platform enriches tumor-derived DNA fragments from blood samples up to 1,000-fold prior to sequencing.

Combined with whole-genome coverage, this enrichment delivers a 30-fold improvement in the limit of detection compared to the first-generation assay, reaching below one part per million under high-end inputs while maintaining an analytical specificity greater than 99%. This sensitivity is intended to detect residual disease across early-stage malignancies and cancers that typically exhibit low ctDNA shedding, such as prostate, kidney, non-small cell lung, and hormone receptor-positive breast cancers. Abbott noted that the cost efficiency of the MAESTRO sequencing workflow permits the whole-genome assay to be deployed broadly to all incoming patients rather than being restricted to select indications.

Multi-Tumor Clinical Validation

Clinical validation studies demonstrate the assay’s longitudinal and landmark predictive performance:

  • Esophageal Cancer: In a study of patients with locally advanced esophageal cancer, longitudinal testing detected ctDNA prior to recurrence in all 14 patients who experienced disease recurrence, yielding 100% clinical sensitivity.
  • Triple-Negative Breast Cancer: Findings from the prospective PARTNER trial demonstrated that a single post-surgery blood draw detected 90% of patients who experienced distant recurrence within 5 years, representing a three-fold improvement over the first-generation assay.
  • Colorectal Cancer: Data from the Beta-CORRECT study presented at the European Society for Medical Oncology congress demonstrated a 30% absolute improvement in recurrence detection within 2 years compared to the first-generation test at a single postoperative blood collection in patients with stage II to IV colorectal cancer.

“For many people affected by cancer, finishing treatment does not mean the uncertainty ends,” says Maimah Karmo, president of the Tigerlily Foundation, in a release. “Waiting for the next scan and wondering whether cancer may return can take an emotional toll. New tools that give care teams more information about recurrence risk can support more meaningful conversations about what comes next.”

Laboratory Operations and EHR Integration

The Oncodetect test was developed, and its analytical performance characteristics determined, by Genomic Health. Testing is performed in a CLIA-certified laboratory qualified to conduct high-complexity clinical testing. The test has not been cleared or approved by the US Food and Drug Administration.

To support laboratory-to-clinic operational workflows, the test is integrated into leading electronic health record systems, enabling ordering and digital result retrieval within hospital information systems. Abbott is evaluating Oncodetect in more than 20 ongoing clinical studies across solid tumor types while seeking payor coverage and international commercial availability.

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