Cancer patients often face lingering doubts after treatment, unsure if the disease has truly vanished. Even when treatment seems successful, tiny remnants of cancer may persist, undetectable by conventional methods. Molecular residual disease (MRD) testing tackles this issue by detecting traces of circulating tumor DNA (ctDNA) in the blood. This data aids doctors in assessing recurrence risks and monitoring treatment effectiveness.
Abbott has launched its advanced Oncodetect MRD test, a personalized, tumor-informed, whole-genome sequencing tool. Designed to provide molecular insights during and after cancer treatment, it complements Abbott’s existing portfolio, which includes the widely used Oncotype DX Breast Recurrence Score test, covering screening, hereditary testing, and genomic profiling.
How the New Test Functions
The test initially uses a patient’s tumor sample to pinpoint unique DNA markers. It then searches for these markers in the blood. At its core is MAESTRO, a technology developed at the Broad Institute’s Gerstner Center for Cancer Diagnostics and enhanced by Abbott. Combined with whole-genome sequencing, this method can track up to 5,000 patient-specific variants. MAESTRO amplifies tumor DNA in blood by up to 1,000 times before sequencing, making cancer signals more detectable. These advancements yield a 30-fold sensitivity improvement, with detection limits below one part per million.
Clinical Performance and Patient Impact
Ongoing clinical studies assess the test’s performance across various solid tumors. In a study of locally advanced esophageal cancer, the test detected ctDNA before recurrence in all 14 patients who relapsed, achieving 100% sensitivity. In the PARTNER triple-negative breast cancer study, the next-generation test identified 90% of patients who later experienced distant recurrence within five years from a single post-surgery blood draw. Data presented at the European Society of Medical Oncology (ESMO) congress showed a 30% absolute improvement in sensitivity for recurrence within two years with the next-generation Oncodetect test, compared with the first-generation test, in patients with stage II–IV colorectal cancer.
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“For many people affected by cancer, finishing treatment does not mean the uncertainty ends,” said Maimah Karmo, a triple-negative breast cancer survivor and president of the Tigerlily Foundation. “Waiting for the next scan and wondering whether cancer may return can take an emotional toll.”
- Broad variant tracking: Whole-genome sequencing monitors up to 5,000 patient-specific variants, increasing opportunities to detect residual disease at critical clinical decision points.
- Tumor DNA enrichment: MAESTRO boosts tumor DNA detection by approximately 1,000-fold.
- Ultrasensitive detection: Detection limits below one part per million, maintaining >99% analytical specificity.
Integration and Future Directions
Abbott is advancing clinical evidence for MRD testing through over 20 ongoing studies, evaluating the next-generation Oncodetect test across tumor types, academic collaborations, and real-world research. The company is also expanding patient access through payer coverage and international initiatives.
It analyzes ctDNA shed into the bloodstream, providing insights into ctDNA level changes over time.
The test has not been cleared or approved by the US Food and Drug Administration. It is performed at Genomic Health Inc., a CLIA-certified lab qualified for high-complexity clinical testing.
