Illumina Announces MRD Kit Ahead of ASCO Meeting

Ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, kicking off this weekend, Illumina has announced a new molecular residual disease (MRD) product. The distributed kit enables solid tumor MRD and blood cancer genomic profiling and, the company says, will enable more labs to adopt MRD detection for clinical research.

It is the first in a new portfolio of WGS oncology research offerings, with additional solutions in development leveraging the latest advancements of the NovaSeq X. Illumina’s MRD research solution is available today for early access to select partners and will launch for global customers next year.

“In precision healthcare, early and accurate detection of molecular residual disease is critical to monitoring patients during and after cancer treatment,” said Todd Christian, senior vice president of Services, Arrays, and Genomic Access at Illumina. “Illumina’s MRD solution for clinical research leverages the advanced sensitivity of whole-genome sequencing, coupled with unparalleled analysis, to enable our customers to more easily deliver the most precise information to advance MRD research. We aim to make WGS in oncology more accessible and scalable to support the integration of precision solutions into the standard of care.”

The MRD solution supports fingerprinting through solid tumor samples, and MRD detection using blood samples, all compatible on NovaSeq Systems. The end-to-end research workflow can be completed in as fast as five days and is optimized for analytical sensitivity as low as 10 ppm, particularly important for early-stage and low-shedding tumors, including breast, ovarian, and renal.

Illumina’s DRAGEN MRD analysis connects each fingerprint to serial circulating tumor DNA (ctDNA). The new MRD solution has been optimized across thousands of samples to develop and demonstrate a ctDNA detection algorithm with 99.5% analytical specificity to distinguish true tumor signals from background noise.

Mayo Clinic evaluated the solution on a small sample cohort and found high concordance among previously characterized paired samples. The results were also highly correlated with clinical and imaging results over time. The team is planning to expand the cohort for additional research with Mayo Clinic and other academic partners.

“We are looking forward to participating in early access and evidence generation for a tumor-informed, non-bespoke whole-genome sequencing approach to MRD,” said Gang Zheng, MD, PhD and professor of Laboratory Medicine and Pathology at Mayo Clinic. “We have seen early pilot results across several solid tumor clinical samples that demonstrated the potential utility of highly sensitive solid tumor MRD detection, and we continue to pilot technologies that help us efficiently progress in our ability to analyze and translate complex genomic arrays.”

Built on recently announced NovaSeq X advancements, including 35B output and Q70 quality scores, a complementary research workflow that will deliver ultra-sensitive MRD detection in the single-digit ppm range leveraging duplex reads is currently in development.

Illumina’s new oncology portfolio builds upon the integrated ecosystem of workflows, data and community across genomic, multiomic, and clinical research applications—anchored on the NovaSeq X.

Illumina and Bristol Myers Squibb will jointly present a poster at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31, from 9:00 a.m. to 12:00 p.m. (abstract ID 8591, poster board #381, Lung Cancer: Non–Small Cell Metastatic track).