Business Model & US Market Entry

A clear path to revenue and reimbursement

Tests through federally certified (CLIA) partner lab
Sells wholesale to gastroenterology practices; practices bill at markup
Both sides profit from day one
No insurance approvals needed to start

LDT Pathway

Same pathway used by Exact Sciences, Guardant Health, and Foundation Medicine. Fastest, most capital-efficient route to clinical traction and M&A positioning.

Obtain Medicare billing code (PLA code)
HMOs such as Kaiser Permanente
Insurance payer coverage
Multiple revenue streams from ColoPro

Cash-Pay Precedents

Guardant Shield: US$895 – 2+ yrs before FDA approval
GRAIL Galleri: US$949 – Mostly patient-pay after 5 years
Natera Signatera: Medicare coverage pathway – Same pathway as ColoPro
Strategic Partnership

Global diagnostics collaboration: an active pathway

JUNE 2025

Initial Engagement

CDA signed. Proteomics platform and preliminary APL data shared.

OCTOBER 2025

Meeting at US HQ

Met Senior VP and Head of BD. Formal process initiated.

NOW

MTA in Progress

Material Transfer Agreement, a critical cross-platform validation step.

THE OPPORTUNITY

Acquisition = Bigger Stage

Partner being acquired by major global diagnostics corp.

Complementary, not competing: we work with whole blood; they work with plasma. The MTA validates ColoPro across sample types. Our whole blood platform remains a distinct proprietary advantage.

Commercial Strategy

The LDT pathway: fastest route to traction, revenue, and M&A

Laboratory Developed Test
LDT
No FDA pre-market approval required
Speed to Market

Real-world evidence and revenue ahead of regulatory. 12-18 months to first revenue.

Proves the Market

Real-world uptake is the most compelling commercial signal for any acquirer.

Revenue Generating

Reimbursement via procedure codes, payer agreements. Not just IP.

Ideal M&A Asset

Acquirers pay a premium. Higher valuation, stronger negotiating position.

The Investment

Two-Tranche Raise — US$2.9M

Pre-money: US$14.3M (A$22M)

TRANCHE 1 — NOW US$1.0M
Hire Head of US Operations
Finalise federally certified (CLIA) partner lab
Begin ColoPro assay transfer & validation
Establish initial gastroenterology practice relationships
Medicare provider registration
TRANCHE 2 — 2027 US$1.9M
Scale US commercial operations
Expand gastroenterology practice network
Medicare billing code & coverage submission
US population validation studies
Family history cohort expansion
Investor Returns

US$150M exit — sector benchmarks

US Series B Diagnostics Median: $157M

Deal Price Stage Revenue Multiple Note
Qiagen → Verogen $150M Early commercial ~$20M ~7.5× Best comp ★
Sonic → Diagnosticum ~$207M Mature profitable ~$70M ~3.2× Revenue floor
Quest → Haystack $300M+ Pre-revenue ~$0 Pure IP Tech premium

Use of Funds — A$1.5M

Science Salaries & LabA$500K
CLIA Lab validationA$450K
Head of US OperationsA$220K
Legal & regulatoryA$130K
Business developmentA$120K
IP / PatentsA$80K
Sangui Bio

Preventing Colorectal Cancer
With a Simple Blood Test

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Sangui Bio Pty Ltd