• Powered by whole-genome sequencing and MAESTRO^* technology, the next-generation Oncodetect test takes a distinct approach to MRD, tracking up to 5,000 patient-specific variants with a limit of detection below one part per million under high-end inputs ^{1, 2, 3}
• The next-generation Oncodetect test builds on more than 20 years of trusted leadership in using genomic information to personalize cancer care 
• Modeling estimates more than 3 million U.S. patients with solid tumors could potentially benefit from MRD testing^†

For many people with cancer, completing treatment can bring a new uncertainty: Is my cancer really gone?

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 tumor 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.^4,5

To help address this need, Abbott (NYSE: ABT) today announced the commercial availability of its next-generation Oncodetect^® MRD test, a personalized, tumor-informed, whole-genome sequencing test designed to provide molecular insights during and after cancer treatment.^1,2 

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 recognized as a standard of care in early-stage breast cancer.⁶ 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 personalized test uses a sample of each patient's tumor 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.^1,5 MAESTRO technology enriches tumor DNA from blood up to 1,000-fold before sequencing, making cancer signals easier to detect.^1,2 Together, these advances achieve a 30-fold improvement in limit of detection to below one part per million.^‡,3,7,8 This ultrasensitive performance is designed to identify residual disease when ctDNA levels are especially low, including in early-stage disease and post-treatment settings.^9,10

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.

"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, a national women's health and oncology patient advocacy organization. "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."

Designed to detect when disease is hardest to find

MRD tests differ in how they identify and track tumor-specific DNA. The next-generation Oncodetect test takes a distinct approach, combining broad whole-genome variant tracking with MAESTRO technology that enriches tumor 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.^1,2
• Tumor DNA enrichment: MAESTRO enriches tumor 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.^3,7,8 

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.^9-11

Building the evidence behind next-generation MRD

Clinical studies are evaluating the performance of the next-generation Oncodetect test across multiple solid tumors. In patients with locally advanced esophageal cancer, longitudinal testing detected ctDNA before recurrence in all 14 patients who experienced recurrence, achieving 100% sensitivity.¹² 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, a three-fold improvement over the first-generation test.¹³

New Beta-CORRECT 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, at a single post-surgical time point in patients with stage II–IV colorectal cancer.¹⁴

"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."

Advancing MRD in cancer care

Abbott's precision oncology tests are fully integrated into leading electronic health record systems, making it easier for physicians to order tests and access results within their existing clinical workflows.

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.