ONETest™ integrates QuantumProbes™ core-genome capture, UniPrep™ library chemistry, walk-away automation, sequencing, and FusionCloud™ / Fusion AI into one RUO platform supporting accredited-lab metagenomic workflows.
ONETest™ reagents and software are provided for research use only. Clinical use requires independent validation, performance, and reporting by an appropriately accredited laboratory under its applicable regulatory, accreditation, and quality framework.
The ONETest™ workflow is designed to make targeted metagenomics operationally practical in a hospital environment: capture the right microbial DNA, prepare a sequencing-ready library, automate repeatable steps, and return ranked analytical outputs through FusionCloud™.
Specimen enters a standardized molecular workflow.
Core-genome regions are enriched across target organisms and related lineages.
Captured DNA is converted into a sequencing-ready DNA library.
Liquid-handling automation supports reproducible DNA-to-sequencer processing.
Fusion AI applies background-aware signal analysis and ranked outputs.
Results are structured for interpretation within a <24-hour workflow.
ONETest™ is built around the practical requirements that determine laboratory implementation: automation, standardized reagents, in-lab sequencing compatibility, cloud-based interpretation, and an implementation path aligned with accredited laboratory validation workflows.
Built around timely laboratory workflows for complex infection evaluation.
Designed to support validation within accredited laboratory workflows.
ONETest™ is designed to run with standard liquid-handling automation and desktop sequencing infrastructure supporting in-house workflows where validation and infrastructure are in place.
FusionCloud™ transforms sequence outputs into ranked, interpretable results using background-aware signal qualification and organism-specific thresholds where validated.
The implementation model links clinical validation, IT/security readiness, automation, and reporting into a repeatable site-validation package.
ONETest™ is not built around a fixed list of short amplicons or a brute-force whole-metagenome workflow. It uses QuantumProbes™ to enrich conserved microbial core-genome regions, preserving meaningful microbial community structure while increasing the pathogen signal needed for clinical interpretation.
QuantumProbes™ target hunderds of thousands of core-genomes from 50 microbial families, enabling broad organism detection and species-level resolution.
ONETest™ preserves a representative view of the microbial community, with approximately R² = 0.74 concordance to whole-metagenome sequencing in BAL samples.
By increasing on-target microbial abundance, ONETest™ reduces sequencing burden and creates cleaner inputs for FusionCloud™ AI interpretation.
QuantumProbes™ can capture up to 20% in genetic distance allowing them to bind all related lineages, thus achieving the capture profile needed for microbiome interpretation.
ONETest™ preserves within-sample microbial diversity while improving sequencing efficiency. The correct manuscript-supported comparison is Shannon diversity correlation of r = 0.74 versus WmGS across BAL samples.
Shannon diversity comparison showing preservation of within-sample microbial diversity.
Targeted enrichment improves microbial signal while reducing inefficient sequencing burden.
The ONETest™ BAL evaluation supports the platform as a complementary laboratory approach for complex lower-respiratory evaluation workflows, including culture-limited and polymicrobial presentations.
High specificity with control-informed interpretation in the BAL clinical cohort.
Across culture-confirmed isolates in the BAL clinical cohort.
Additional BAL findings beyond routine bacterial / AFB culture; requires clinical correlation.
Detected ≥1 culture-confirmed organism in culture-positive validation specimens.
ONETest™ helps reduce the gap between sample and structured microbiologic evidence by transforming genomic data into ranked clinical intelligence for hospital laboratories and critical-care teams.
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