Whole Genome Oncodetect MRD Test Is Now Available for Solid Tumors

A next-generation, whole genome sequencing version of the Oncodetect molecular residual disease (MRD) test is now commercially available to detect cancer during and after treatment in patients with solid tumors.¹

The personalized, tumor-informed assay tracks circulating tumor DNA (ctDNA) through up to 5000 patient-specific variants, compared with up to 200 for the first-generation test, with a limit of detection below 1 part per million under high-end inputs (a 30-fold improvement) and an analytical specificity rate above 99%.

“The next chapter is about understanding what may be happening at the molecular level during and after treatment,” Rick Baehner, MD, divisional vice president and chief medical officer of precision oncology at Abbott’s cancer diagnostics business, said in the release.

How does the whole-genome Oncodetect test work?

The test uses a tumor sample, typically obtained by biopsy or surgery, from which patient-specific DNA markers are identified. Blood draws are then searched for the same markers, with serial draws used to monitor change over time. The test is built on MAESTRO (minor-allele-enriched sequencing through recognition oligonucleotides), a technology that enriches tumor DNA from blood up to approximately 1000-fold before sequencing. In its original description, MAESTRO paired large-scale mutation enrichment with duplex sequencing, allowing for up to 10,000 low-frequency mutations to be tracked with up to 100-fold fewer reads per locus than standard hybrid-capture duplex sequencing.²

The Oncodetect MRD test results are reported quantitatively as ctDNA measured in MTM/mL.¹ The test may be optimally used in early-stage and low-shedding cancers, including prostate, lung, kidney, and hormone receptor–positive breast cancers.

What clinical data support the use of the Oncodetect MRD test?

In a study of 36 patients with locally advanced esophageal cancer, with 331 plasma samples collected before and after surgery, the Oncodetect V2 test detected ctDNA at the first postoperative sample in several with recurrence, and all 14 evaluable patients (100%) were deemed to have ctDNA-positive disease in at least 1 postoperative sample before recurrence.³ In over half of samples with detectable ctDNA, the level fell below the detection limit of first-generation assays.

A prospective substudy of the randomized phase 2/3 PARTNER trial (NCT03150576) evaluated whole exome and whole genome tumor-informed ctDNA assays in patients with early triple-negative breast cancer receiving neoadjuvant chemotherapy with or without olaparib (Lynparza).⁴ PARTNER is an open-label trial testing olaparib added to platinum-based neoadjuvant chemotherapy in patients with triple-negative or germline BRCA-mutated breast cancer. The whole genome test identified 90% of patients who later had distant recurrence within 5 years from a single post-surgery blood draw, a 3-fold improvement compared with the first-generation test.¹

Most recently, findings from the β-CORRECT study of patients with stage II to IV colorectal cancer were presented in a poster at the 2026 ESMO Congress.⁵ In this study, the whole genome test showed an approximately 30% absolute improvement in sensitivity for recurrence within 2 years compared with the first-generation whole exome sequencing test at a single post-surgical time point. Additionally, the accuracy of Oncodetect V2 in 209 samples from 14 cancer types was compared with the whole exome sequencing assay targeting 50 to 200 variants; the positive percent agreement was 100% (95% CI, 97.3%-100%), and Oncodetect V2 detected all samples that were identified as ctDNA positive by the whole exome sequencing assay (n = 139).⁵ Furthermore, 19 results that were deemed ctDNA negative by the whole exome sequencing assay were reclassified as ctDNA positive by Oncodetect V2; 17 of these results had ctDNA levels below 15 ppm per Oncodetect V2. Moreover, although both assays were significantly prognostic for disease-free survival (DFS) in their respective populations, multivariable analyses showed that ctDNA status per Oncodetect V2 was the most significant predictor of DFS. Oncodetect V2 also showed a higher detection rate for non-liver metastases vs previously published findings with the whole exome sequencing assay.

References

1. Abbott launches whole-genome sequencing Oncodetect molecular residual disease (MRD) test to detect traces of cancer during and after treatment. News release. Abbott. October 26, 2026. Accessed October 26, 2026. https://abbott.mediaroom.com/2026-10-26-Abbott-launches-whole-genome-sequencing-Oncodetect-R-molecular-residual-disease-MRD-test-to-detect-traces-of-cancer-during-and-after-treatment
2. Gydush G, Nguyen E, Bae JH, et al. Massively parallel enrichment of low-frequency alleles enables duplex sequencing at low depth. Nat Biomed Eng. 2022;6(3):257-266. doi:10.1038/s41551-022-00855-9
3. Rhoades J, Patel A, Xiong K, et al. Ultrasensitive circulating tumor DNA analysis improves detection of molecular residual disease in locally advanced esophageal cancer. Clin Cancer Res. Published online August 21, 2026. doi:10.1158/1078-0432.CCR-25-4852
4. Dooley A, Fontenele RS, Grasse G, et al. Evaluation of whole-exome and whole-genome sequencing tumor-informed circulating tumor DNA MRD assays in patients with early triple-negative breast cancer (TNBC) receiving neoadjuvant chemotherapy (NAC) with or without olaparib: a prospective sub-study of the PARTNER trial. J Clin Oncol. 2026;44(suppl 16):570. doi:10.1200/JCO.2026.44.16_suppl.570
5. Hashimoto T, Nakamura Y, Young G, et al. Validation of the ultrasensitive tumor-informed WGS MAESTRO MRD assay in β-CORRECT. Presented at: 2026 ESMO Congress; October 23-27, 2026; Madrid, Spain. Abstract 4426P.