Abbott has officially launched its next-generation Oncodetect molecular residual disease (MRD) test, a significant leap forward in precision oncology. This personalized, tumor-informed, whole-genome sequencing test is designed to offer unprecedented molecular insights, allowing clinicians to track cancer activity during and after treatment with extreme precision.
The Oncodetect test functions by analyzing a patient’s unique tumor DNA markers and subsequently monitoring those specific signatures within the bloodstream to detect circulating tumor DNA (ctDNA). The system integrates whole-genome sequencing with MAESTRO (Minor Allele Enriched Sequencing Through Recognition Oligonucleotides), a sophisticated technology originally developed at the Broad Institute of MIT and Harvard’s Gerstner Center for Cancer Diagnostics and subsequently refined by Abbott.
The technological leap provided by the next-gen platform is substantial. While the first-generation iteration tracked up to 200 patient-specific variants, the new test can monitor as many as 5,000. Furthermore, the integration of MAESTRO allows for a 1,000-fold enrichment of tumor DNA in the blood, resulting in a 30-fold improvement in the limit of detection. The test is now capable of identifying residual disease at levels below one part per million, a sensitivity threshold that enables the detection of cancer traces even in early-stage patients or long after initial treatments have concluded.
“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,” said Dr. Rick Baehner, divisional VP and chief medical officer for precision oncology at Abbott. “MRD represents an important evolution in precision oncology, helping move cancer care beyond waiting for signs of recurrence toward more informed decisions.”
The clinical potential of the test has already been demonstrated in several high-profile studies. In a study of locally advanced esophageal cancer, the test achieved 100% sensitivity, identifying ctDNA in every patient who eventually experienced a recurrence. In the PARTNER study focusing on triple-negative breast cancer, a single post-surgery blood draw successfully identified 90% of patients who experienced distant recurrence within five years—a rate three times higher than the first-generation test. Additionally, data presented at the European Society for Medical Oncology congress confirmed a 30-percentage-point improvement in sensitivity for recurrence within two years for stage II–IV colorectal cancer patients.
Because the MAESTRO-based sequencing is highly cost-efficient, Abbott intends to make this whole-genome analysis accessible to all new patients rather than reserving it for specific clinical cases. This rollout arrives on the heels of Abbott’s $21 billion acquisition of the Oncodetect franchise earlier this year, signaling a major strategic focus for the company as it seeks to redefine the standard of care for cancer surveillance and long-term monitoring.
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