BIRT Platform · Research Use Only
Precision Medicine
for Autoimmune Disease, start with MS
Panel Performance
Recommended operating point
MS vs. NMO differential
90.0% sens / 72.1% spec · n=761 · @80% cov
91.3%
AUC
MS subtyping · RRMS → SPMS
90.5% sens / 44.4% spec · n=507 · @80% cov
78.8%
AUC
Early MS screening (EDSS < 2.5)
90.0% sens / 32.5% spec · n=246 · @100% cov
74.2%
AUC
100-seed Monte Carlo cross-validated · ~1,900 samples awaiting
3,018
Total samples · 997 sequenced in Phase 1
63K+
RNA markers per Phase 1 run
Market Opportunity
Autoimmune disease burden
in US and globally
Oncology
$141B
Projected market size
Tempus AI$1.59B rev (2025)
Guardant Health$780M rev (2025)
Exact Sciences$2.8B rev (2025)
Autoimmune
$20B+
Projected TAM
~$02026 revenue
Blue ocean · No current players| Disease | US | EU | India | China | GCC | Rest of World | Total |
|---|---|---|---|---|---|---|---|
| Multiple SclerosisCURRENT | 1M | 700k | 200k* | 70k | 20k | 810k | 2.8M |
| Rheumatoid Arthritis | 1.5M | 3M | 8M | 6M | 500k+ | ~1M | 19M |
| Type 1 DiabetesNEXT | 2M | 1.5M | 1.2M | 1M | 300k | ~500k | 6.5M |
| Lupus (SLE) | 400k | 500k | 1.5M | 1M | 150k | ~400k | 4M |
| Crohn's Disease | 1M | 1M | 150k | 250k | 75k | ~200k | 2.7M |
| Ulcerative ColitisNEXT | 1.3M | 1.5M | 1.5M | 400k | 75k | ~300k | 5.1M |
First Indication
First Disease Indication: Multiple Sclerosis
2.8M+
patients worldwide
4–7 yrs
symptom → diagnosis
$70-90K
annual DMT cost/patient
$8.0B+
precision medicine TAM
Dataset advantage
Blood-based neuroimmune study sample sizes
Biostate AI
3,018
Octave MS
~300
NfL (Disanto)
170
SPARC-M
80
MSDA (Bhise)
15
Clinical Framework
The MS Patient Journey
Business Model
One platform, three markets
Differential Dx
MS vs NMO
91.3% AUC
90.0% sens / 72.1% spec @ 80% cov
Price
$800
TAM
$20M/yr
Population
25K new dx/yr (US)
Misdiagnosis between MS and NMO can be catastrophic — NMO is worsened by standard MS therapies. BIRT reads the underlying B-cell biology of NMO to catch cases the AQP4-IgG CBA misses (~25% of NMO is seronegative).
MS Subtyping
RRMS → SPMS transition
78.8% AUC
90.5% sens / 44.4% spec @ 80% cov
Price
$2,000/yr
TAM
$2.0B/yr
Population
1M prevalent RRMS
The RRMS→SPMS transition is currently invisible. Neurologists wait 2–5 years for retrospective clinical confirmation while irreversible damage accumulates. BIRT provides a prospective molecular signal — annual screening, mammography analog.
MS Screening
Rule-out blood-first triage
74.2% AUC
90.0% sens / 32.5% spec @ 100% cov · NPV >98%
Price
$300
TAM
$6.0B/yr
Population
20M US high-risk individuals
Before MRI, a $300 blood draw rules out MS with NPV > 98%. A high-sensitivity screen that avoids unnecessary $4,000 MRIs and shortens the 4–7 year diagnostic delay.
Total addressable market
$8.0B+ / yr
$16 fully-loaded COGS per sample → >90% gross margin at $300 screen price
Validation
One blood draw, three actionable clinical results
Deep Dive 1
NMO Diagnosis: Wrong Drug = Catastrophic Harm
The diagnosis matters — wrong treatment is dangerous
Misdiagnosis → catastrophic vision loss, paralysis
How do you tell them apart?
AQP4 Antibody Test
75%
Sensitivity
$800
Price
⚠ Misses 25% of NMO patients (seronegative)
Biostate AI Blood Panel
90.0%
Sensitivity
$800
Price
✓ Works for seronegative NMO · 91.3% AUC · same blood draw
Deep Dive 2
MS subtyping: detect progression before irreversible damage
Annual direct cost rises with disability (US, DMT-inclusive)
Pharmacy is the dominant cost component at all severity levels; non-pharmacy medical & support costs grow with disease progression
Source: Jones E et al. BMC Health Serv Res 2016;16:294 (2015 USD, N=715 US patients); reviewed in Schauf et al. JMCP 2023
2–5 yrs
to confirm RRMS → SPMS transition today
Biostate AI — MS Subtyping
90%
sensitivity @80% cov
→
$2,000
test price / yr
No alternative test exists
$2B
TAM · 1M RRMS × $2K/yr
Serial monitoring = recurring revenue
Deep Dive 3
MS Screening: Blood-First Triage Before MRI
Patient flow (per 1,000 symptomatic)
🩺
1,000
patients
→
🩸
Blood test
NPV >98%
→ 290 cleared ✓
→ 710 → MRI
>98%
NPV — rules out MS
90%
sensitivity @100% cov
13:1 procedure-to-test ratio
Afirma Precedent (Thyroid)
Surgery avoided
$10K
Test price
$3,500
AUC ~75–80% · $1.5B+ company
Biostate Equivalent (MS)
Saved per patient
$1,160
(30% MRIs avoided)
Test price
$300
AUC 75.4% · $16 COGS
Healthcare system saves $860/patient · 2.9× ROI
Patented Technology
BIRT vs. other RNAseq
10×
cost reduction
($16 COGS) — lower labor and reagent use
90%
lower sample required
(5ng RNA) — compatible with historical/damaged samples
40k
additional non-coding RNA visible
additional information-bearing biomarkers
| Feature | BIRT (patented) | mRNA seq | Microarrays |
|---|---|---|---|
| coding mRNA | 20k | 20k | 20k |
| lncRNA | 19k | 3k | 0 |
| miRNA | 1,879 | 0 | 0 |
| snoRNA | 942 | 0 | 0 |
| other ncRNA | 20,942 | 0 | 0 |
| Total features | 63k | 23k | 20k |
| Dynamic Range | 5+ logs | 5+ logs | 3 logs |
| Input required | 5ng | 100ng | 100ng |
Positioning
BIRT vs. MRI: Complementary, Not Competing
| 🩸 BIRT RNAseq | 🧠 MRI | 🧪 Autoantibody | |
|---|---|---|---|
| Price | $300 ($16 COGS) | $1,600–8,400 | $730–6,200 |
| Data / test | 63K+ features | 1 image | 1 analysis |
| MS vs NMO | 91.3% AUC | Subjective pattern reading | Misses 25% seronegative |
| MS Subtyping | 78.8% AUC | Retrospective only (2–5 yrs) | No test exists |
| Early MS Screen | 75.4% AUC · NPV >98% | Gold standard but $3K–8K | No test exists |
| CNS inflammation | ✗ Blood can't see CNS | ✓ Direct imaging | No |
| Peripheral immune | ✓ Leading indicator | ✗ Lagging (structural) | Partial |
🔬+🧠BIRT doesn’t replace MRI — it complements it. For the three clinical decisions where blood works — subtyping, screening, and NMO differential — no MRI or autoantibody test currently provides the answer.
Roadmap
Development timeline
2025
2026
2027
Q1
Q2
Q3
Q4
Q1
Q2
Clinical
MS
Retrospective (N=3,000)
⭐Phase I complete
Prospective NMO
Prospective Subtyping → ≥1 yr
T1D
Retrospective
UC
Retrospective
Technology
BIRT RNA
✓ Commercialized
DNA WES
✓ Developed
Optimization
Methylation
Development
Regulatory
Certification
CAP/CLIA
→
NMO LDT ⭐
Done / commercialized
Active / planned
Extends beyond visible timeline
Commercial milestone