Whole-Genome MRD Test Detects Traces of Cancer During and After Treatment

Molecular residual disease (MRD) testing addresses this challenge by searching blood for circulating tumor DNA to provide information about treatment response and surveillance. Building on this approach, a newly launched test combines tumor-informed whole-genome sequencing with targeted DNA enrichment to detect cancer signals below one part per million when higher DNA inputs are available.

Abbott has announced the commercial availability of its next-generation Oncodetect MRD test for patients with solid tumors. The test uses tumor tissue, typically obtained through biopsy or surgery, to identify DNA changes unique to each cancer and create a molecular fingerprint. Blood samples are then analyzed for the same tumor-specific signals, allowing subsequent draws to track changes in circulating tumor DNA over time. Oncodetect combines whole-genome sequencing with MAESTRO, or minor allele enriched sequencing through recognition oligonucleotides, technology.

Whole-genome sequencing enables Oncodetect to track up to 5,000 patient-specific variants, compared with up to 200 in the first-generation assay. MAESTRO technology further enhances sensitivity by enriching tumor DNA from blood by up to approximately 1,000-fold before sequencing. Under high-end input conditions, the assay has a limit of detection below one part per million, representing a 30-fold improvement, while maintaining greater than 99% analytical specificity.

The test was developed, and its performance characteristics determined, by Genomic Health. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The Genomic Health laboratory performing the assay is certified under CLIA regulations and qualified to perform high-complexity testing.

Clinical studies are evaluating the test across multiple solid tumor types. In locally advanced esophageal cancer, longitudinal testing detected circulating tumor DNA before recurrence in all 14 patients who experienced recurrence, corresponding to 100% sensitivity. In the PARTNER study of triple-negative breast cancer, a single post-surgery blood draw identified 90% of patients who developed distant recurrence within five years, representing a three-fold improvement over the first-generation test. In patients with stage II–IV colorectal cancer, Beta-CORRECT data showed a 30% absolute improvement in sensitivity for detecting recurrence within two years at a single post-surgical time point.

Oncodetect must be ordered by a healthcare provider and is integrated into leading electronic health record systems to support test ordering and results access within existing clinical workflows. More than 20 ongoing studies are evaluating the assay across tumor types, alongside academic collaborations and real-world research. Abbott is also working to expand payor coverage and international access.