LIMS Development for Genomics and Clinical Genomics Workflow Automation for Genomic Testing Operations
From test order to clinical report delivery — we engineer the genetic testing workflow software and lab informatics platforms that make every step traceable, automated, and clinically defensible.
Lab Order #LO-20240506-0041
Patient: J. Smith · Test: WES Hereditary Cancer Panel · Ordered: 09:02 UTC
Order
Sample In
Pipeline
Delivery
Sample Tracking
✓ Accessioned 09:18
✓ QC Pass · Routing: Seq-Bay-3
TAT Monitor
SLA Target: 5 days
Current: Day 2 · On Track
Clinical Report — Auto-Generated
BRCA1 c.5266dupC · Pathogenic · ACMG Class 5 · FHIR R4 DiagnosticReport
Signed: Dr. A. Patel · 11:47 UTC · TAT: 2d 2h 45m · Audit logged
Why Genomics Lab Operations Break Down
What We Build: End-to-End Clinical Genomics Workflow Software
We engineer every layer of the clinical genomics workflow — from the first test order through to the final report in the clinician’s hands. Six capabilities. One connected system.
LIMS Development & Customization for Genomics Labs
A generic LIMS was not built for genomic testing. We develop purpose-designed lab informatics software for genomics — and customize existing LIMS platforms when you already have an investment to protect. Whether it is a ground-up build or a customization of LabWare, STARLIMS, or a comparable platform, we add the genomics-specific workflows, instrument interfaces, and downstream integrations that off-the-shelf LIMS cannot support.
- Sample login, accessioning, and chain-of-custody tracking with assay-specific QC thresholds and automated hold logic at each workflow stage
- Multi-site sample management with configurable routing rules and inter-lab transfer tracking
- Direct instrument interface modules for sequencer data ingestion and QC analyser integration
- Immutable audit trail — every sample state change, user action, and system event timestamped and query-able for CAP/CLIA inspection and regulatory review
Test Order Management System for Genomics
The front end of the clinical genomics workflow is where most delays begin. Our test order management system for genomics handles the full pre-analytic cycle — before a sample ever arrives in the lab.
- Clinician-facing order entry with configurable test menus, clinical indication logic, and role-based ordering rules
- Pre-authorization and payer eligibility verification — automated against payer rules with exception workflows for manual review
- Requisition generation, patient consent capture, and kit dispatch management for send-out programmes
- Real-time order status tracking from submission through accessioning — visible to ordering clinicians without EHR login, with direct Epic and Cerner EHR integration to eliminate duplicate data entry
Sample Tracking Software for Clinical Labs
- Barcode and QR-driven receipt, labelling, and accessioning with configurable acceptance criteria by sample type
- Automated sample routing to the correct assay workflow based on test order, sample type, and available instrument capacity
- Automated TAT monitoring with configurable alerts when samples approach SLA thresholds — before they breach
- Storage management: plate mapping, freezer location, long-term biobank inventory, and chain-of-custody for stored specimens
Between receipt and sequencing, samples pass through dozens of state transitions. Our sample tracking software for clinical labs automates that chain so nothing gets lost, nothing gets processed out of sequence, and every team member has live visibility into where every sample stands.
Clinical Report Generation & Structured Delivery
The clinical report is the product your lab delivers. We engineer report generation systems that produce structured, clinician-readable outputs automatically — with no copy-paste, no version ambiguity, and no manual formatting step between variant classification and report issuance.
- Configurable report templates by assay type, clinical indication, and provider organisation — automated variant-to-report population with no manual re-entry from interpretation tools
- Structured data output alongside PDF: HL7 v2 ORU messages and FHIR R4 DiagnosticReport resources for direct EHR ingestion — supporting EHR genomics integration with Epic, Cerner, and equivalent systems
- Amendment and addendum workflow: tracked changes, approval routing, and version history for every report issued
- TAT compliance tracking — generation timestamp, approval timestamp, and delivery confirmation recorded per order for SLA and accreditation reporting
Tertiary Analysis Tooling & ACMG Variant Classification Workflow Software
Between variant calls and a clinical report sits the most time-intensive step in genomic medicine: variant interpretation. We build workflow software that makes tertiary analysis structured, scalable, and auditable — turning ACMG variant classification from a bottleneck into a governed, repeatable process.
- ACMG/AMP classification framework with configurable rule sets per assay type, structured evidence capture at the variant level, and complete audit trail through sign-off
- VUS (Variant of Uncertain Significance) management: tracked review schedules, reclassification triggers on new evidence, and automated notification to ordering clinicians on reclassification
- Somatic variant tiering per AMP/ASCO/CAP guidelines for oncology panels — with configurable evidence tiers and clinical actionability levels
- Knowledge base integration: ClinVar, ClinGen, OMIM, and lab-internal interpretation history surfaced at the variant level — supporting defensible, evidence-backed classification at scale
Nextflow, WDL & Snakemake Pipeline Development
We build secure, purpose-designed portals that deliver genomic test results to the right person in the right format. Both portals are built on HIPAA-compliant architecture with encryption at rest and in transit, MFA, and complete access logging.
Provider Portal
Clinician-facing interface for order placement, real-time status tracking,
result review, and report access — integrated with Epic and Cerner via HL7 FHIR
so genomic results surface inside the provider’s existing EHR workflow.
- Order placement and tracking
- Result and variant detail review
- FHIR R4 EHR integration
- Role-based access and audit logging
Patient Portal
Consumer-grade patient interface for result delivery, educational content,
follow-up pathway guidance, genetic counseling scheduling, and cascade screening
workflow support — built to engagement standards patients expect from modern digital health.
- Plain-language result summaries
- Genetic counseling integration
- Cascade screening workflows
- Consent management and data privacy
Ready to connect your lab and clinic?
Discuss your lab and clinical workflow requirements with our team.
Who We Build Clinical Lab Software For
Our clinical genomics workflow platforms and LIMS development services serve organizations at the intersection of genomics and patient care.
Clinical & Reference Genomics Labs
CAP/CLIA-accredited labs running complex genomic test menus that need lab informatics software purpose-built for genomics — not repurposed from chemistry or haematology workflows.
- LIMS built for panels, WES, WGS
- Pre-auth & order management
- Automated report generation
- HIPAA-compliant architecture
Health Systems & Academic Medical Centres
Integrated delivery networks building in-house genomics programmes — needing clinical workflow software that connects to Epic or Cerner and integrates genomic findings into existing care pathways.
- EHR genomics integration Epic/Cerner
- Provider and patient portals
- FHIR R4 DiagnosticReport delivery
- Variant interpretation workflows
Genomics & Diagnostics Startups
Early-stage diagnostic companies launching novel genomic tests who need a clinical genomics platform that can pass regulatory scrutiny, impress enterprise customers, and scale from Day 1.
- Clinical platform from scratch
- Investor-ready architecture
- ACMG classification tooling
- Flexible engagement models
Platforms That Power Your Clinical Genomics Workflow
Our clinical workflow engineering feeds directly into these NonStop platforms
Clinical Genomics Platform
The full-lifecycle platform: test ordering, sample tracking, pipeline execution, variant interpretation, report generation, and EHR delivery in one governed system.
Patient & Provider Portal
Consumer-grade result delivery, genetic counseling integration, cascade screening support, and consent management — HIPAA-compliant and EHR-connected.
AI Genomic Data & Analytics Platform
AI-accelerated variant classification and VUS re-analysis sitting directly on top of your interpretation workflow layer.
Frequently Asked Questions
We do both. For labs needing purpose-built lab informatics software, we develop custom LIMS from the ground up - designed around your specific assay types, genomic workflows, and compliance requirements. For labs that already have a LIMS investment, we deliver LIMS customization services for genetic testing labs - extending existing platforms with genomics-specific modules, instrument interfaces, and the downstream integrations that off-the-shelf systems cannot support. The right approach depends on your current system, your volume, and your five-year roadmap. We help you make that decision during scoping, not after contract signing.A production-ready clinical bioinformatics pipeline must be reproducible across runs, scalable for clinical sample volumes, auditable for regulatory compliance, and integrated with clinical systems such as LIMS and reporting platforms.
Most errors in genomics lab operations happen at handoff points between disconnected systems. Clinical genomics workflow automation eliminates those handoffs: sample receipt triggers accessioning automatically, QC pass triggers pipeline execution, pipeline output populates the interpretation queue, and completed variant classification populates the report template. The result is shorter turnaround time, fewer transcription errors, a complete digital audit trail, and measurable TAT reduction against your baseline. Every workflow automation we deliver is benchmarked against a pre-implementation measurement so the improvement is quantified, not assumed.
We build HL7 v2 and FHIR R4 integrations for full bidirectional data exchange between your clinical genomics platform and Epic or Cerner. Inbound: patient demographics, orders, and clinical context flow from the EHR into your genomic workflow, eliminating duplicate entry and ensuring accurate patient matching. Outbound: completed reports are delivered as HL7 v2 ORU messages or FHIR R4 DiagnosticReport resources directly into the EHR result flow, surfacing genomic findings in the clinician's existing view without a separate portal login. We manage the Mirth Connect configuration, HL7 message design, FHIR resource mapping, and end-to-end validation.
A standard LIMS manages samples and tracks test status. A clinical genomics platform connects that to bioinformatics pipelines, ACMG variant classification workflow software, tertiary analysis tooling, clinical report generation, FHIR-based EHR delivery, and patient-facing portals - in one governed, HIPAA-compliant system with an audit trail across every layer. Most labs start with a LIMS and bolt disconnected tools around it. We build the integrated clinical genomics platform that replaces that patchwork - or connect your existing LIMS to the rest of the stack through a clean integration layer. The distinction matters most at inspection time and at scale: an integrated platform holds up under both.
Ready to Replace Your Lab Workflow Patchwork with a Platform That Actually Scales?
Tell us your assay menu, your current system stack, and your biggest operational bottleneck.
We will scope a build tailored to your lab.