Roche Launches AXELIOS 1 Next-Generation Sequencing Platform Powered by Proprietary SBX Technology

Roche's launch of AXELIOS 1 introduces a sequencing architecture that could materially alter how pharma QA teams approach genomic characterization of biologics and cell-based therapies. Built on proprietary sequencing by expansion (SBX) technology, the platform converts DNA and RNA into high signal-to-noise Xpandomers read by a reusable CMOS sensor array, enabling same-day whole-genome sequencing within a single instrument footprint.

For manufacturing and quality operations, the platform's design addresses a persistent constraint: the need to switch systems or revalidate workflows when scaling between small-batch and high-throughput runs. AXELIOS 1's flexible run setup is intended to handle both without workflow reconfiguration, a characteristic relevant to process validation programs where instrument consistency is a documented requirement under 21 CFR Part 211 and ICH Q10 quality system expectations.

Roche confirmed collaborations with Hartwig Medical Foundation and Broad Clinical Labs, with published data supporting accuracy, throughput, and speed claims. Additional partnerships include 10x Genomics for single-cell and spatial application kits, Google DeepVariant for SBX variant calling support, and an open-source bioinformatics suite, XOOS, available at no cost. These integrations reduce the third-party tool qualification burden for labs building SBX-based workflows.

The platform launches into a sequencing market currently valued at USD 7.3 billion, with double-digit growth projected over the near term. Roche positions AXELIOS 1 as capable of displacing incumbent technologies in research settings, with a stated longer-term pathway into clinical applications, including personalised healthcare. That clinical trajectory will carry its own regulatory qualification requirements, though no regulatory submissions have been announced at this stage.

Library preparation kits and the XOOS bioinformatics suite will be offered alongside the instrument, giving early adopters a defined reagent and analysis ecosystem to qualify against before broader deployment.

Laboratories evaluating AXELIOS 1 for genomic QC or biologics characterization will need to assess SBX performance data from the Hartwig and Broad Clinical Labs studies against their own method validation acceptance criteria before any GMP-adjacent integration can proceed.

Source: Roche via GlobeNewswire, 29 June 2026.