Agentic AI · Rare Disease · Multi-Omics

Building the intelligence
layer for rare disease
diagnoses.

Viakrama is designing an orchestrated multi-agent AI system to compress the diagnostic odyssey for rare disease patients — from years to hours. We are currently in architecture and pre-regulatory development.

Development notice: Viakrama is not yet a licensed or approved medical device. The platform described here represents our intended architecture and is not currently available for clinical use. Regulatory submissions are ongoing.
Explore Architecture → Register Interest
300M+ People with rare diseases globally
4.8 yrs Average time to correct diagnosis
7,000+ Rare diseases, 80% genetic in origin

Clinicians can't
synthesise at genomic scale.

A clinical geneticist reviewing a rare case must simultaneously hold 47 phenotypic features, interpret a VCF file with millions of variants, and cross-reference against a literature base growing by thousands of papers monthly.

The bottleneck is not intelligence — it is cognitive bandwidth at scale. No single clinician can perform phenotype-to-genotype matching across the full search space fast enough.

Viakrama is architecting an agentic reasoning layer to fill that gap. We are building — not deployed.

01
Initial symptoms present
Often misclassified as common conditions due to phenotypic overlap
02
Multiple specialist referrals
Average 7 physicians seen before genetic testing is ordered
~2 years
03
Genomic sequencing ordered
WES or WGS produces variant calls — manual review begins
04
Manual variant interpretation
Bioinformaticians prioritise variants; clinicians review literature
~2.8 years
05
Viakrama target window
Intended agentic synthesis target: compress steps 3–4 from months to hours
target: hours

Three agents.
One orchestrated case file.

The Viakrama architecture centres on a shared structured case file that each agent reads and writes to. No agent has a global view — each is specialised. The orchestrator coordinates sequencing, handles failures, and maintains audit state.

Every inference is cited. Every agent decision is logged. Designed from the ground up for clinical auditability — a requirement, not an afterthought.

Development status
Agent architecture design Complete
Prototype / proof of concept In progress
Clinical validation studies Not started
FDA / EMA pre-submission In progress
HIPAA / GDPR compliance audit In progress
Clinical deployment Not yet available
Proposed multi-agent system — conceptual diagram
Orchestrator Layer
Case Orchestrator
case_file.json · audit trail · agent sequencing
Agent 01 · Clinical
Clinical Agent
  • EHR ingestion (HL7 FHIR, CDA)
  • HPO term extraction from free text
  • Phenotype ranking + uncertainty scores
  • Ontology hierarchy traversal
  • Differential phenotype disambiguation
In design
Agent 02 · Bioinformatics
Bioinformatics Agent
  • Dynamic Python/R pipeline generation
  • VCF variant prioritisation
  • ClinVar / OMIM / gnomAD queries
  • Transcriptomic & proteomic analysis
  • Sandboxed code execution
In design
Agent 03 · Synthesizer
Synthesizer Agent
  • Phenotype–genotype cross-reference
  • RAG over PubMed & Orphanet
  • ACMG variant classification
  • Explainable report generation
  • Confidence scoring & alternatives
In design
ClinVar
Variant classifications
OMIM
Gene–disease map
gnomAD
Population allele freq.
PubMed + Orphanet
Literature RAG layer

Designed for a
regulated future.

HIPAA
In progress
Architecture being designed with PHI encryption at rest and in transit as a core constraint. BAA framework under legal review. No patient data is currently processed.
Design phase — 35% of compliance framework documented
GDPR
In progress
Article 22 human-in-the-loop safeguards planned as a structural requirement. EU data residency architecture being scoped. DPA engagement planned for 2026.
Scoping phase — 25% of compliance framework documented
FDA SaMD
Pre-submission
Viakrama is assessing its intended use classification as a Software as a Medical Device. Pre-submission meeting with FDA being prepared. No regulatory clearance has been sought or received.
Early stage — pre-submission Q-submission in preparation
ISO 13485
Planned
Quality management system alignment with ISO 13485 is planned as a prerequisite for CE marking under the EU MDR. QMS design will begin following prototype validation.
Planned — not yet initiated

Follow the
build.

We are onboarding clinical genetics units and research institutions as design partners — not as users. We want to build the right thing with the right people.

The platform is not yet available. No clinical data will be collected at this stage.

For design partnership or research collaboration enquiries only.