Abbott launches Oncodetect MRD test

Even after treatment, small amounts of cancer may remain in the body at levels that can be difficult to detect. Molecular residual disease (MRD) testing looks for traces of circulating tumour DNA (ctDNA) in the blood, providing additional information that can help physicians understand recurrence risk, monitor treatment response, and inform decisions about what comes next.

For more than 20 years, the Oncotype DX Breast Recurrence Score test has helped physicians use genomic information to personalize breast cancer treatment and is recognised as a standard of care in early-stage breast cancer. The next-generation Oncodetect test builds on that foundation, expanding Abbott's ability to provide molecular insights across the cancer care continuum. Abbott's broad cancer diagnostics portfolio spans cancer screening, hereditary cancer testing, genomic profiling, recurrence risk assessment, and MRD testing.

The personalised test uses a sample of each patient's tumour to identify its unique DNA markers, then looks for those same signals in the blood. At the heart of the next-generation Oncodetect test is MAESTRO, a technology developed at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard and enhanced by Abbott. Combined with whole-genome sequencing, this approach expands variant discovery from up to 200 variants in the first-generation test up to as many as 5,000 patient-specific variants. MAESTRO technology enriches tumour DNA from blood up to 1,000-fold before sequencing, making cancer signals easier to detect. Together, these advances achieve a 30-fold improvement in limit of detection to below one part per million. This ultrasensitive performance is designed to identify residual disease when ctDNA levels are especially low, including in early-stage disease and post-treatment settings.

Importantly, MAESTRO enables cost-efficient sequencing, allowing Abbott to offer the whole-genome Oncodetect test to all new patients from day one, rather than reserving the technology for select cases.

MRD tests differ in how they identify and track tumour-specific DNA. The next-generation Oncodetect test takes a distinct approach, combining broad whole-genome variant tracking with MAESTRO technology that enriches tumour DNA from blood to create many opportunities to detect ctDNA when very little is present.

• Broad variant tracking: Whole-genome sequencing tracks up to 5,000 patient-specific variants, expanding opportunities to detect residual disease at critical clinical decision points.
• Tumor DNA enrichment: MAESTRO enriches tumour DNA detection up to ~1,000-fold ^1,2
• Ultrasensitive detection: A limit of detection below one part per million, while maintaining >99% analytical specificity.

This ultrasensitive performance is designed to identify residual disease when ctDNA levels are especially low, including in early-stage cancers, low-shedding cancers such as prostate, lung, kidney, and HR+ breast, and post-treatment settings.

"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 Vice President, Chief Medical Officer, Precision Oncology, Abbott's cancer diagnostics business. "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."

Abbott continues to build clinical evidence for MRD testing through more than 20 ongoing studies evaluating the next-generation Oncodetect test across tumor types, academic collaborations, and real-world research. The company is also working to broaden patient access through payor coverage and international expansion.