Illumina, Inc. issued a press release on November 9, 2026, announcing an early access program for a new ultrasensitive duplex sequencing workflow designed to detect circulating tumor DNA in plasma samples for molecular residual disease research.

Key Highlights

  • New workflow announced: Illumina disclosed an early access program for a duplex sequencing workflow targeting circulating tumor DNA (ctDNA) detection in plasma samples for molecular residual disease (MRD) research.
  • Sensitivity level: According to the filing, the workflow demonstrated reproducible detection of ctDNA at 2.5 parts per million levels in representative studies.
  • Sample input: The research-use-only workflow supports 5-10 nanograms of cell-free DNA input, the filing stated.
  • Sequencing accuracy: The workflow delivers quality scores above Q65, according to the announcement, combining NovaSeq X sequencing with duplex chemistry and DRAGEN bioinformatics.
  • Kit shipment timeline: Kits for the early access program are expected to ship in the first quarter of 2027, the company disclosed.
  • Early access partner: NYU Langone Health was identified in the filing as an early access user, applying the workflow to MRD research.
  • Turnaround time: The company stated the WGS-based MRD research workflows deliver a turnaround time of less than five days.

Illumina's Duplex Sequencing Approach and MRD Research Portfolio Expansion

Illumina, Inc. (NASDAQ:ILMN) disclosed the launch of an early access program for a new ultrasensitive sequencing workflow aimed at supporting molecular residual disease and tumor evolution research. According to the filing, the workflow's duplex chemistry analyzes both strands of a DNA molecule simultaneously, increasing confidence in detection by confirming each base call using both complementary strands of the original DNA molecule. The company stated that observing the same change on both strands increases confidence that a finding is biological rather than an artifact introduced during library preparation or sequencing.

The filing described the new workflow as complementing Illumina's existing WGS Oncology Prep product, which the company said supports both tumor fingerprinting and longitudinal ctDNA monitoring in a standardized whole-genome workflow. WGS Oncology Prep was noted as also being available through early access, having been announced earlier in the year. The combined use of NovaSeq X platform sequencing and DRAGEN bioinformatics software generates duplex consensus reads, optimizes quality scores, and interrogates thousands of tumor-specific variants across the genome, according to the company.

Cande Rogert, described in the filing as vice president and Global Head of Advanced Science at Illumina, was quoted as saying: "Researchers need effective ways to find the faintest traces of tumor DNA - signals that can be especially difficult to detect in early-stage, low-shedding, or low-mutation-burden tumors." Matija Snuderl, MD, director of Molecular Pathology at NYU Langone Health, was also quoted in the filing, noting the institution's participation in the early access program and its interest in a "non-bespoke approach" for MRD research. The filing noted that the company's WGS-based workflows use a standardized process from library preparation through DRAGEN analysis. The company included forward-looking statements subject to its standard cautionary language regarding risks and uncertainties.

What Was Disclosed

Illumina announced an early access program for a duplex ctDNA sequencing workflow detecting at 2.5 parts per million sensitivity with 5-10 ng input, using NovaSeq X and DRAGEN software, with kit shipments expected in the first quarter of 2027.