Emerging data from Abbott’s cancer diagnostics, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, underscore a paradigm shift in cancer detection, monitoring, and risk stratification. Notably, the Oncodetect® whole-genome sequencing (WGS)-based molecular residual disease (MRD) assay, developed by Exact Sciences (now part of Abbott), demonstrated superior sensitivity in detecting circulating tumor DNA (ctDNA) in patients with early-stage triple-negative breast cancer (TNBC), with significant prognostic implications.
Additional studies highlighted the clinical utility of multi-cancer early detection (MCED) testing, artificial intelligence (AI)-driven risk stratification, and insights into systemic immune response during neoadjuvant therapies. Collectively, these findings reinforce the central role of precision diagnostics in informing and individualizing cancer care across the continuum.
The landscape of oncology is rapidly evolving, with molecular diagnostics at the forefront of this transformation. At the 2026 annual meeting of the American Society of Clinical Oncology (ASCO), Abbott Cancer Diagnostics presented a breadth of new clinical evidence demonstrating the expanding utility of its integrated diagnostics portfolio. These advances address critical decision points in cancer care—from early detection and risk stratification to therapy guidance and recurrence monitoring—ushering in a new era of precision medicine.
WGS-Based Oncodetect® MRD Testing in Early-Stage TNBC
One of the central highlights was the demonstration of the Oncodetect® WGS-based MRD assay in early-stage TNBC, as reported in a prospective sub-study of the PARTNER trial. MRD detection using ctDNA post-treatment is a powerful prognostic tool in TNBC, where recurrence risk stratification remains a clinical challenge after chemotherapy and surgery.[1][2]
Key Findings:
- Improved Sensitivity: The WGS-based test, which tracks up to 5,000 tumor-informed variants, detected ctDNA in 9 out of 10 recurrences, a substantial improvement over the 3 out of 9 detected by the earlier whole-exome sequencing (WES)-based assay.
- Higher Detection Rates: Across all time points, the WGS-based test achieved ctCNA detection rates from 35% to 89%, outperforming the WES assay due to its ultrasensitive design.
- Prognostic Value: ctDNA-positive patients, as determined by the WGS-based assay, exhibited a 52-fold higher risk of distant metastatic recurrence or breast cancer-specific death.
- Clinical Impact: These results demonstrate the WGS-based Oncodetect® assay’s potential to identify patients at the highest risk post-operatively, enabling more informed surveillance and therapeutic interventions.
Clinical Implications
Enhanced MRD testing can transform post-treatment management in TNBC by enabling earlier detection of recurrence risk. This enables clinicians to optimize monitoring and consider adjuvant strategies in those with persistent MRD, while potentially sparing others from unnecessary interventions.
Integrated Diagnostics Across the Cancer Care Continuum
Abbott’s presentations at ASCO 2026 extend beyond MRD, showcasing innovations that support the continuum of care:
- Multi-Cancer Early Detection (MCED): The Cancerguard® MCED test and the DETECT-A study provided evidence that blood-based MCED screening is well tolerated by patients, does not increase anxiety or depression, and maintains high adherence to Standard-of-Care (SoC) screening over a five-year follow-up. The CRANE study further validated the MCED approach in a Japanese cohort.[3][4]
- AI-Driven Risk Stratification: The RlapsRisk BC (RR) AI pathology-based test, independently validated in the NSABP B-28 trial, accurately stratified patients with HR+/HER2- node-positive early breast cancer. RR identified two-thirds of N1 patients as low risk for distant recurrence, supporting more nuanced decisions regarding adjuvant CDK4/6 inhibitor use. [5]
- Refined Imaging Strategies: AI-enhanced mammography selection for supplemental MRI screening significantly reduced false-positive rates while targeting women at higher risk for invasive cancers, improving screening efficiency without compromising detection.
- Immune Profiling During Neoadjuvant Therapy: In the CARABELA trial, systemic cytokine dynamics distinguished chemotherapy from endocrine therapy plus CDK4/6 inhibition. Inflammatory and angiogenic cytokines increased during chemotherapy and were associated with residual disease, suggesting new biomarkers of treatment resistance.[6]
Future direction
Collectively, these studies illuminate the future direction of cancer diagnostics:[7]
- Ultrasensitive MRD testing using WGS enables detection of minimal residual disease at previously undetectable levels, providing actionable prognostic information and supporting earlier intervention in high-risk TNBC.
- MCED assays are feasible and acceptable in real-world populations, with no deleterious impact on psychological well-being or adherence to established screening modalities.
- AI-based risk stratification and refined imaging strategies are optimizing patient selection for advanced diagnostic procedures, reducing unnecessary interventions, and facilitating resource allocation.
- Systemic immune profiling is emerging as a marker of therapeutic response and resistance, offering potential for further personalization of therapy.
Next steps
The convergence of advanced molecular assays, multi-biomarker detection, and artificial intelligence is driving a new standard in oncology diagnostics. Abbott’s data presented at ASCO 2026 exemplify this shift toward greater precision, earlier intervention, and more patient-centric care. As these technologies are further validated and integrated into clinical practice, they hold promise to markedly improve outcomes for patients across the cancer spectrum.
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Note:* Oncodetect® is a tumor-informed molecular residual disease (MRD) test designed to provide a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By leveraging whole exome sequencing, it analyzes circulating tumor DNA (ctDNA) shed into the bloodstream by tumors, offering critical insights into changes in ctDNA levels over time. This quantitative assessment of ctDNA (measured as MTM/mL) helps healthcare providers better understand a patient’s MRD status and make informed treatment decisions
Clinical trials
ADAPT – Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT) ClinicalTrials.gov ID NCT01779206
Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer (planB) – ClinicalTrials.gov ID NCT01049425
Platinum and Polyadenosine 5’Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer (PARTNER) – ClinicalTrials.gov ID NCT03150576
A case-control clinical evaluation of the Exact Sciences Multi-Cancer Early Detection(MCED) in Japan – UMIN000059407
Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients (CARABELA) – ClinicalTrials.gov ID NCT04293393
References
[1] Dooley A, Fontenele RS, Grasse G, Worley J, Lay J, Casford S, Dayimu A, Tarantino S, Abraham J, Feng L, Ratty J, Minde K, Fu Y, Ramesh A, Hu J, Culver B, Young G, Innis P, Palomares MR, Baehner F, PBCP Study Group, PARTNER Trial Group. Evaluation of whole-exome and whole-genome sequencing tumor-informed circulating tumor DNA MRD assays in patients with early triple-negative breast cancer receiving neoadjuvant chemotherapy with or without olaparib: a prospective sub-study of the PARTNER trial. J Clin Oncol. 2026;44(suppl 16):abstract 570. Poster Session.
[2] Abraham JE, Pinilla K, Dayimu A, Grybowicz L, Demiris N, Harvey C, Drewett LM, Lucey R, Fulton A, Roberts AN, Worley JR, Chhabra A, Qian W, Vallier AL, Hardy RM, Chan S, Hickish T, Tripathi D, Venkitaraman R, Persic M, Aslam S, Glassman D, Raj S, Borley A, Braybrooke JP, Sutherland S, Staples E, Scott LC, Davies M, Palmer CA, Moody M, Churn MJ, Newby JC, Mukesh MB, Chakrabarti A, Roylance RR, Schouten PC, Levitt NC, McAdam K, Armstrong AC, Copson ER, McMurtry E, Tischkowitz M, Provenzano E, Earl HM. The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer. Nature. 2024 May;629(8014):1142-1148. doi: 10.1038/s41586-024-07384-2. Epub 2024 Apr 8. PMID: 38588696; PMCID: PMC11136660.
[3] Beer TM, Buchanan A, Choudhry OA, Roberta J, Wagner ES, Elias PZ, Honushefsky AM, Lehman A, Sadler JR, Sheridan K, Walter CN, Lennon AM, Papadopoulos N. Beyond detection: five-year screening behaviors and patient-reported perceptions in DETECT-A participants. J Clin Oncol. 2026;44(suppl 16):abstract 10534.
[4] Yamazaki T, Nakamura Y, Imai M, Fujisawa T, Konishi H, Kato H, Oketani K, Styn M, Lehman A, Beer TM, Yoshino T, Yano T. Cancer recognition and assessment through non-invasive evaluation (CRANE): a prospective clinical validation study of a multi-biomarker class multi-cancer early detection test in Japan. J Clin Oncol. 2026;44(suppl 16):abstract TPS10629. Poster Session.
[5] Rastogi P, Tang G, Bennett JP, Shao J, King B, Freeman T, Yu G, Baehner R, Sefta M, Aubert V, Hocquet E, Andre F, Garberis I, Geyer CE Jr, Mamounas EP, Wolmark N, Lacroix-Triki M. AI-driven risk stratification for distant recurrence in node-positive HR+/HER2− early breast cancer: independent validation in the NSABP B-28 trial. J Clin Oncol. 2026;44(suppl 16):abstract 558. Poster Session.
[6] Guerrero-Zotano A, Martin M, Perez-Lopez ME, Martinez-Jañez N, Cardenas JD, Gil Gil M, Ruiz-Borrego M, Sanchez-Rovira P, Del Barco S, Bermejo B, Andrés R, Ponce-Lorenzo JJ, Martínez-De Dueñas E, Herranz J, Caballero R, Portela M, Caffarel MM, Rojo F, Lallena MJ, Alba E. Systemic cytokine dynamics during neoadjuvant chemotherapy versus endocrine therapy and CDK4/6 inhibition in high-risk luminal breast cancer: results from the GEICAM/2019-01-CARABELA trial. J Clin Oncol. 2026;44(suppl 16):abstract 619. Poster Session.
[7] Gluz O, Kuemmel S, Nitz U, Braun MW, Luedtke-Heckenkamp K, Darsow M, Forstbauer H, Aktas B, Grischke EM, Schumacher C, Reimer T, Malter W, Nuding B, Wuerstlein R, Christgen M, Kreipe HH, Kates RE, zu Eulenburg C, Baehner R, Harbeck N. Role of neoadjuvant versus adjuvant chemotherapy, dose density, and treatment schedule in biologically high-risk HR+/HER2- breast cancer: a pooled analysis of the WSG ADAPT-HR+/HER2- and PlanB trials. J Clin Oncol. 2026;44(suppl 17):abstract LBA515. Rapid Oral Abstract Session.
Featured image: The ASCO Annual Meeting. Photo courtesy: © 2023 – 2026 ASCO/Scott Morgan/ Used with permission.
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