Abbott has commercially launched its next-generation Oncodetect molecular residual disease (MRD) assay, a personalised blood test that identifies traces of cancer in patients with solid tumours.
Available through healthcare providers, the tumour-informed diagnostic tool utilises whole-genome sequencing to monitor circulating tumour deoxyribonucleic acid (DNA) during and after therapy.
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Abbott estimates that over three million patients in the US with solid tumours could benefit from the testing.
The diagnostic approach integrates minor allele-enriched sequencing through recognition oligonucleotides (MAESTRO) enrichment technology, developed at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard and refined by Abbott.
By boosting tumour DNA levels up to 1,000-fold before sequencing, the test can track up to 5,000 patient-specific variants, compared with a limit of 200 in the earlier test.
The methodology delivers analytical specificity of more than 99% and a detection limit below one part per million, representing a 30-fold improvement in sensitivity over the first-generation release.
Cost-efficient sequencing allows the test to be offered across all new patients immediately.
Abbott cancer diagnostics business precision oncology chief medical officer and divisional vice-president Dr Rick Baehner said: “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.
“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.”
Clinical investigations across solid tumours include data in locally advanced oesophageal cancer, where longitudinal tracking detected circulating tumour DNA before relapse in all 14 patients who experienced recurrence.
In the PARTNER trial for triple-negative breast cancer, a single post-surgical blood sample identified 90% of participants who experienced distant recurrence within five years, representing a three-fold improvement over the initial version.
Furthermore, findings from the Beta-CORRECT study, presented at the European Society for Medical Oncology Congress, demonstrated a 30% absolute increase in two-year recurrence sensitivity for stage II–IV colorectal cancer using a single post-operative blood draw.
Abbott has integrated the assay into electronic health record networks and is conducting more than 20 studies across multiple tumour types while pursuing broader reimbursement and international availability.
Within Abbott’s precision portfolio, which includes the Oncodetect and Oncotype DX Breast Recurrence Score products, the test is processed by Genomic Health under Clinical Laboratory Improvement Amendments (CLIA) regulations for high-complexity laboratory testing.
The US Food and Drug Administration (FDA) has neither cleared nor approved the diagnostic.
Recently, Abbott commercially rolled out SimpleScreen CRC in the US, introducing an FDA-approved blood test for colorectal cancer screening.
