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[ precision medicine ]

Precision Medicine

for Autoimmune Disease, start with MS

Panel PerformanceOne blood draw, three actionable clinical results
MS vs. NMO differential
90.0% sens72.1% specn=761@80% cov
91.3%
AUC
MS subtyping · RRMS SPMS
90.5% sens44.4% specn=507@80% cov
78.8%
AUC
Early MS screening (EDSS < 2.5)
90.0% sens32.5% specn=246@100% cov
74.2%
AUC
the largest blood transcriptomic study of MS and NMO to date

[ 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
DiseaseUSEUIndiaChinaGCCRest of WorldTotal
Multiple SclerosisCURRENT1M700k200k*70k20k810k2.8M
Rheumatoid Arthritis1.5M3M8M6M500k+~1M19M
Type 1 DiabetesNEXT2M1.5M1.2M1M300k~500k6.5M
Lupus (SLE)400k500k1.5M1M150k~400k4M
Crohn's Disease1M1M150k250k75k~200k2.7M
Ulcerative ColitisNEXT1.3M1.5M1.5M400k75k~300k5.1M

[ 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
3,018samples · 997 in Phase I
10× the next study
Existing studies
Octave MS
10% of Biostate~300
NfL (Disanto)
5.6% of Biostate170
SPARC-M
2.6% of Biostate80
MSDA (Bhise)
0.5% of Biostate15

[ clinical framework ]

The MS Patient Journey

Blood-based assays at three decision points in the MS workflow, replacing or complementing imaging and CSF analysis at a fraction of the cost.

MS Patient Journey: screening → symptoms → early MS/CIS → confirmed MS → protected, with Biostate AI interventions at each stage

[ 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
$16fully-loaded COGS / sample>90% gross margin
at $300 screen price

[ validation ]

One blood draw, three actionable clinical results

MS vs NMO classification
Disease Typen = 761 · MS + NMO
AUC @ 80%
91.3%
± 0.3%
AUC @ 100%
88.3%
± 0.2%
Sensitivity79.4%± 0.7%
Specificity94.4%± 0.3%
PPV84.5%± 0.6%
NPV92.5%± 0.3%
MS Subtype — Prog. vs Relapsing
MS Clinicaln = 507 · MS-only
AUC @ 80%
78.8%
± 0.6%
AUC @ 100%
74.7%
± 0.6%
Sensitivity58.3%± 1.6%
Specificity82.2%± 0.7%
PPV34.8%± 1.1%
NPV92.7%± 0.3%
Early MS (EDSS<2.5) vs Control
Disease Typen = 246 · EarlyMS + Ctrl
AUC @ 80%
75.4%
± 0.9%
AUC @ 100%
74.2%
± 0.7%
Sensitivity55.9%± 1.8%
Specificity77.1%± 1.5%
PPV65.4%± 1.6%
NPV73.2%± 0.9%

[ deep dive 1 ]

NMO Diagnosis: Wrong Drug = Catastrophic Harm

The diagnosis matters — wrong treatment is dangerous
NMO Drug
MS Drug
NMO Patient
Correct
Relapse · Paralysis · Death
MS Patient
Worsens disease
Correct
Misdiagnosis → catastrophic vision loss, paralysis
How do you tell them apart?
AQP4 Antibody Test
Misses 25% of NMO patients
75%
Sensitivity
$800
Price
Biostate AI Blood Panel
Works for seronegative · 91.3% AUC
90.0%
Sensitivity
$800
Price
Same blood draw, broader coverage at parity price.

[ 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
$51.8K
$57.9K
$67.1K
Mild
EDSS <3
Moderate
EDSS 3–5
Severe
EDSS >5
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
2–5yrs
Diagnosis Delay
Time required today to confirm an RRMS → SPMS transition retrospectively.
$2B
Total Addressable Market
1M RRMS × $2K/yr · serial monitoring drives recurring revenue.
90%sensitivity
@80% cov
$2,000test price
/ yr
Biostate AI — MS Subtyping
A prospective blood-based signal for RRMS→SPMS, priced for annual serial monitoring. No alternative test exists.

[ deep dive 3 ]

MS Screening: Blood-First Triage Before MRI

Patient flow (per 1,000 symptomatic)
1,000
symptomatic patients
Blood test
NPV >98%
290 cleared
710 → MRI
>98%
NPV — rules out MS
safe to clear without imaging
90%
sensitivity @100% cov
13:1 procedure-to-test ratio
Market precedent · Afirma → Biostate
Precedent
Afirma (Thyroid)
AUC ~75–80%
Surgery avoided
$10K
Test price
$3,500
$1.5B+
company
Biostate equivalent
MS Screening
AUC 75.4% · $16 COGS
Saved / patient
$1,160
30% MRIs avoided
Test price
$300
2.9× ROI
$860 saved / patient

[ 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
information-bearing biomarkers
FeatureBIRT (patented)mRNA seqMicroarrays
coding mRNA20k20k20k
lncRNA19k3k0
miRNA1,87900
snoRNA94200
other ncRNA20,94200
Total features63k23k20k
Dynamic Range5+ logs5+ logs3 logs
Input required5ng100ng100ng

[ positioning ]

BIRT vs. MRI: Complementary, Not Competing

🩸 BIRT RNAseq🧠 MRI🧪 Autoantibody
Price$300 ($16 COGS)$1,600–8,400$730–6,200
Data / test63K+ features1 image1 analysis
MS vs NMO91.3% AUCSubjective pattern readingMisses 25% seronegative
MS Subtyping78.8% AUCRetrospective only (2–5 yrs)No test exists
Early MS Screen75.4% AUC · NPV >98%Gold standard but $3K–8KNo test exists
CNS inflammation✗ Blood can't see CNS✓ Direct imagingNo
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
In progress
Planned
Commercial milestone