Abbott launches next-generation Oncodetect cancer test in US
Abbott has integrated Oncodetect into electronic health record networks and is conducting more than 20 studies across multiple tumour types.
USA—Abbott has commercially launched its next-generation Oncodetect molecular residual disease (MRD) assay in the US to improve the detection of cancer cells remaining after treatment in patients with solid tumours.
Healthcare providers can order the personalised blood test, which uses whole-genome sequencing to detect circulating tumour deoxyribonucleic acid (DNA) during and after treatment.
Abbott estimates that more than three million US patients with solid tumours could benefit from the test.
Enhanced detection sensitivity
The assay combines whole-genome sequencing with minor-allele-enriched sequencing using recognition oligonucleotides (MAESTRO), an enrichment technology developed at the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard and refined by Abbott.
The technology increases tumour DNA concentration by up to 1,000-fold before sequencing, enabling the test to track up to 5,000 patient-specific genetic variants, compared with 200 in the earlier version.
Abbott reports analytical specificity above 99% and a detection limit below one part per million, representing a 30-fold improvement in sensitivity over the first-generation assay.
According to the company, more cost-efficient sequencing will support testing across its eligible patient population, although broader adoption will also depend on clinical evidence, reimbursement, and access through healthcare providers.
Dr Rick Baehner, chief medical officer and divisional vice-president of Abbott’s precision oncology business, said cancer care is increasingly focused on understanding molecular changes during and after treatment, rather than relying solely on the detection of visible disease.
He noted that MRD testing could help clinicians make more informed decisions throughout cancer care by identifying molecular evidence of residual disease before conventional methods detect recurrence.
Clinical evidence across solid tumours
Clinical investigations have evaluated Oncodetect across several cancer types.
In patients with locally advanced oesophageal cancer, longitudinal monitoring detected circulating tumour DNA before relapse in all 14 patients who subsequently experienced recurrence.
In the PARTNER trial involving patients with triple-negative breast cancer, a single blood sample collected after surgery identified 90% of participants who developed distant recurrence within five years.
Abbott reported that this represented a threefold improvement over the initial version of the test.
Separately, findings from the Beta-CORRECT study, presented at the European Society for Medical Oncology Congress, showed a 30-percentage-point absolute increase in two-year recurrence sensitivity for stage II to IV colorectal cancer using a single postoperative blood sample.
Expansion of precision oncology testing
Abbott has integrated Oncodetect into electronic health record networks and is conducting more than 20 studies across multiple tumour types.
The company is also pursuing broader reimbursement and international availability, developments that could influence access to personalised cancer monitoring and the adoption of MRD testing in routine clinical practice.
The assay forms part of Abbott’s precision oncology portfolio, which also includes the Oncotype DX Breast Recurrence Score test.
Genomic Health processes Oncodetect in a laboratory operating under the US Clinical Laboratory Improvement Amendments (CLIA) requirements for high-complexity testing.
The US Food and Drug Administration (FDA) has neither cleared nor approved Oncodetect.
Separately, Abbott recently launched SimpleScreen CRC in the US, an FDA-approved blood test for colorectal cancer screening.
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