Abbott has announced the commercial availability of its next-generation Oncodetect molecular residual disease (MRD) test, a personalised, tumour-informed test that uses whole-genome sequencing to detect traces of cancer during and after treatment.
Even after completing treatment, small amounts of cancer may remain in the body at levels that are difficult to detect. Molecular residual disease (MRD) testing analyses blood samples for traces of circulating tumour DNA (ctDNA), providing additional information that can help physicians assess recurrence risk, monitor treatment response, and inform subsequent care decisions.
Abbott’s next-generation Oncodetect MRD test aims to address this need by providing molecular insights during and after cancer treatment.
How does the Oncodetect MRD test work?
The Oncodetect MRD test is available for patients with solid tumours and must be ordered by a healthcare provider.
The personalised test uses a sample of the patient’s tumour, typically obtained through a biopsy or surgery, to identify DNA changes specific to the cancer and establish a molecular ‘fingerprint’. A blood sample is then collected and tested for these tumour-specific signals. Additional blood tests over time can provide a molecular view of how the disease may be changing.
At the core 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 further enhanced by Abbott.
Combined with whole-genome sequencing, the approach expands the number of patient-specific variants that can be identified from up to 200 with the first-generation test to as many as 5,000. MAESTRO enriches tumour DNA in blood by up to 1,000-fold before sequencing, helping make cancer-associated signals easier to detect.
Together, these advances deliver a 30-fold improvement in the limit of detection, to below one part per million. This level of sensitivity is designed to help identify residual disease when ctDNA levels are particularly low, including in early-stage disease and after treatment.
MAESTRO also enables cost-efficient sequencing, allowing Abbott to offer whole-genome sequencing to all new patients from day one, rather than reserving the technology for select cases.
“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 and chief medical officer of precision oncology at 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,” he added.
Image source: Abbot
Clinical validation of Oncodetect test
According to Abbot, clinical studies are being conducted to evaluate the performance of the next-generation Oncodetect test across multiple solid tumour types.
In patients with locally advanced oesophageal cancer, longitudinal testing detected ctDNA before recurrence in all 14 patients who experienced a recurrence, achieving 100% sensitivity in this study population.
In the PARTNER study of triple-negative breast cancer, the next-generation test identified 90% of patients who later experienced distant recurrence within five years, based on a single post-surgical blood sample. This represented a three-fold improvement over the first-generation test.
New data from the Beta-CORRECT study, presented at the European Society for Medical Oncology (ESMO) congress, showed a 30% absolute improvement in sensitivity for detecting recurrence within two years with the next-generation Oncodetect test compared with the first-generation test. The comparison was based on a single post-surgical time point in patients with stage II–IV colorectal cancer.
Abbott’s precision oncology tests are integrated into leading electronic health record systems, enabling physicians to order tests and access results within their existing clinical workflows.
The company continues to build clinical evidence for MRD testing through more than 20 ongoing studies evaluating the next-generation Oncodetect test across tumour types, alongside academic collaborations and real-world research.
Abbott said it is also working to broaden patient access through payer coverage and international expansion.
