Investor Overview

Redefining critical care with in-hospital metagenomics.

Fusion Genomics is advancing ONETest™, an on-site targeted metagenomic platform designed to help close diagnostic gaps in life-threatening infections and support accredited hospital laboratories moving from Dx to Rx in less than 24 hours.

This overview is intended to orient qualified investors to the clinical problem, platform strategy, validation evidence, and commercial direction behind Fusion Genomics.

Investment Thesis

A platform built around the diagnostic gap in high-acuity infection care.

Unmet clinical need

Current methods can be slow, narrow, or operationally difficult to deploy inside hospital laboratories.

Platform solution

ONETest™ combines QuantumProbes™, automation, UniPrep™, sequencing, and FusionCloud™ Actionable Intelligence.

Commercial direction

Fusion is focused on hospital-centered deployment, validation partnerships, and scalable implementation workflows.

Pain Point Snapshot

The problem is not a lack of testing. It is a lack of timely, actionable answers.

Critical-care teams often need broad pathogen detection inside the treatment window, but conventional diagnostics and send-out testing can leave patients without actionable microbiology when it matters most.

50%

Undiagnosed infections

In key high-acuity indications, a substantial fraction of suspected infections can remain unresolved using current standard methods.

$20B

Estimated hospital burden

Delayed or missed infection diagnosis creates significant direct hospital cost burden through prolonged care, uncertainty, and empiric treatment.

Days–weeks

Critical delay window

Culture and send-out workflows may not return actionable answers within the critical-care decision window.

Why Now

Sequencing is mature. The bottleneck is implementation.

Hospitals already understand the value of faster, broader infectious-disease answers. The challenge is making metagenomics operationally practical, economically viable, and interpretable within hospital laboratory workflows.

01

Culture is slow and incomplete

Empiric therapy remains common when conventional methods do not identify the causal organism quickly enough.

02

PCR is fast but narrow

Panel-based testing can miss unexpected, emerging, or off-panel organisms in complex hospital samples.

03

Send-out WmGS creates friction

Send-out models can be expensive, slower, and less aligned with hospital operational economics.

04

Interpretation is the hard layer

Metagenomics needs background-aware, organism-specific interpretation rather than undifferentiated organism lists.

Platform Moat

Fusion controls the key layers required for hospital metagenomics.

ONETest™ is not a single assay component. It is an integrated platform stack spanning enrichment chemistry, library preparation, automation, sequencing workflow, and software interpretation.

Validation & Traction

Evidence built from real hospital-relevant specimens.

Fusion’s investor narrative is anchored in clinical validation data, platform development across diverse sample types, and hospital-centered implementation work.

540+

BAL validation cohort

ONETest™ PathoGenome has been evaluated across a lower-respiratory BAL validation study focused on pathogen detection in hospital-relevant samples.

98%

Agreement with culture

Reported clinical agreement with standard-of-care culture testing in the BAL validation narrative.

3,000+

Diverse samples tested

Fusion’s broader platform history includes clinical, respiratory, environmental, and surveillance sample types.

Hub

Hospital-centered model

Fusion is advancing a hub-to-in-house implementation strategy with hospital partners and qualified laboratory workflows.

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Commercial Strategy

Start with clinical pull. Scale through hospital networks.

Fusion’s commercialization model is designed to reduce adoption friction: educate the clinical users, enable hub-based experience, and support in-house conversion where institutional validation and operational fit are established.

01

Clinical seeding

Engage infectious disease, ICU, transplant, oncology, and respirology champions around unresolved diagnostic gaps.

02

Hub experience

Allow institutions to gain experience through validated hub workflows before committing to in-house adoption.

03

In-house conversion

Support hospitals moving toward internal implementation where volume, validation, infrastructure, and economics align.

Expansion path

Lower-respiratory infections provide the initial focus, with future menu expansion opportunities across bloodstream, CNS, and sterile-site infections where supported by appropriate validation.

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Investor Access

Detailed materials are available to qualified investors upon request.

Investor materials, detailed validation data, financial model, and supporting diligence documents are not publicly downloadable from this website and may be provided only to qualified investors following appropriate review.

Forward-looking information

This page may contain forward-looking statements, estimates, and projections. Please review Fusion Genomics’ Legal & Regulatory Notices.