diagnostic testing lims

Designed for the Complexity of Modern Diagnostic Testing

From high-throughput molecular workflows to evolving assay requirements, diagnostic labs face increasing complexity that demands a connected system built to adapt. Labbit's graph-native architecture preserves the relationships between samples, workflows, instruments, and results—allowing teams to evolve without sacrificing control, traceability, or compliance.

Trusted By

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Vercyte Logo
Linus Bio Logo
Helix Logo
Billion To One Logo
Vercyte Logo
Linus Bio Logo
Helix Logo
Billion To One Logo
Vercyte Logo
Linus Bio Logo
Helix Logo
Billion To One Logo

Why Diagnostic Testing Labs Need a LIMS Built on Connected Data

Diagnostic testing workflows rarely follow a single, linear path. Different sample types, assay methodologies, branching workflows, bioinformatics analysis, and evolving test menus create a web of interconnected information that must remain intact from accessioning through reporting. Managing that complexity requires more than storing data—it requires preserving the relationships behind every result.

Labbit's graph-native architecture captures those relationships by design, giving teams immediate access to complete sample-to-result provenance and the confidence to support clinical decisions, investigations, and regulatory expectations.

Key Benefits for Diagnostic Testing Labs

Configurability

Complex Workflows, Modeled Natively

Build your lab’s complex reality into Labbit using highly visual, AI-assisted BPMN-based configuration that captures every step, decision, and workflow path — no coding, no workarounds.

adaptability

Faster Change Deployment

Adapt workflows faster while maintaining control, compliance, and system stability with Labbit’s built-in version control that provides full visibility into what changed to scope and accelerates revalidation.

automation

Increased Accuracy & Efficiency

Automate repetitive tasks and data capture with Labbit's workflow engine and robust integrations. Keep data flowing and processes running consistently to improve integrity, reduce errors, and accelerate turnaround times.

compliance

Audit-Ready by Design

Embed compliance directly into workflows and enforce steps in alignment with CLIA, CAP, and FDA requirements. Every event is captured in fully traceable audit trails so you can confidently answer auditor questions and demonstrate compliance.

scalability

Performance That Scales

Scale testing volumes, expanding test menus, and laboratory operations with a flexible, cloud-based platform that adapts to changing demands without sacrificing performance, traceability, or data integrity.

traceability

Complete Sample Provenance

Trace every result back to its originating sample, workflow version, instrument, analyst, and supporting data. Labbit's graph-native data model preserves these relationships by design, making complete provenance instantly accessible—not reconstructed.

Supporting the Complete Diagnostic Testing Lifecycle

pre-analytical

Complete Accuracy From Accessioning to Assignment

Standardized digital order forms and required field enforcement capture complete, accurate sample and assay information from the very start. Orders are automatically routed to the correct testing workflow, carrying pre-analytical data through each subsequent step to maintain complete sample context throughout the testing lifecycle.l data through each subsequent step to maintain complete sample context throughout the testing lifecycle.

Dashboard interface of Labbit software showing a live workflow diagram for DNA Extraction and Library Prep with steps like Pass Through, Blood Lysis, Saliva Lysis, Extraction, Tagment Genomic DNA, Tagmentation DNA, Amplify and Cleanup Libraries, Pool Libraries, and Manual Pooling.

analytical

Every Step, Exactly to Protocol

Labbit can be configured around your exact SOPs to guide bench work precisely, step-by-step through analytical procedures, whether preparing samples for sequencing or performing PCR-based and other molecular assays. Data is captured directly from connected instruments to streamline the analytical stage while ensuring every action remains fully traceable.

Digital form interface titled DNA Extraction and Library Prep/Post Tagmentation DNA displaying selectable kit lot numbers, SOP checklist with checked steps, and thermal cycler PCR program instructions.

post-analytical

End-to-End Traceability for Faster Review & Reporting

Results, including bioinformatics analysis and variant calls where applicable, are captured against workflow and method, with every entry attributed to a user and timestamped at creation. Labbit enforces your review and approval steps before a result can be reported, automatically routing each result to the right reviewer to keep turnaround time on track.

Workflow dashboard showing sample audit trails with status 'Invalidated & Used' listed under accession, batch, tagment genomic DNA, and post-tagmentation DNA samples, alongside workbook details and status marked complete.

quality control

Detect Issues Earlier & Investigate Faster

Failed QC events, repeat testing, and flagged results move into a structured investigation path inside Labbit, connecting the flagged result directly to instrument history, reagent lots, and prior testing so root-cause analysis doesn't require piecing together information from separate systems. Built-in dashboards also surface QC trends and recurring investigation patterns across runs, giving your team visibility to catch issues before they affect additional samples.

Dashboard showing a horizontal bar chart of average turnaround time (TAT) and tasks started per day for various lab tasks like Fragment Analysis, QC Sorting, QC Analysis, Qubit, Batch Samples, and more.

Explore Key Features for Diagnostic Testing Labs

Complex Workflow Configuration

Visually model complex lab workflows with precision, capturing every step, decision, and dependency exactly as they operate in reality.

Real-Time Lab Monitoring

Monitor every sample, run, and workflow in real time with an interactive view of laboratory operations, making it easy to identify bottlenecks before they impact turnaround times.

Inventory & Instrument Tracking

Track reagent inventory, consumables, and instrument readiness to avoid delays, support testing continuity, and ensure assays are performed with qualified equipment.

Configuration Version Control

Maintain a complete history of every workflow and assay configuration change, with version comparisons that simplify review, validation, and controlled deployment.

Context-Rich Audit Trails

Automatically capture immutable records of every event with full context so you can answer auditor questions quickly and with confidence.

eSignatures & Approval Workflows

Enforce role-based sign-off at each review step, with electronic signatures backed by real-time authentication.

Customer Spotlight

Helix

“As we look ahead, we’re always asking how quickly we can iterate—how quickly we can release updates to a workflow or create new ones. Labbit is a key part of that, enabling us to test, validate, and bring new workflows into production more efficiently.”

Tyler Cassens

Senior Product Manager, Helix

REGULATORY COMPLIANCE + DATA SECURITY

Traceability and integrity by design

Labbit provides complete visibility across workflows with immutable audit trails and full traceability of every action and system change—so you can operate with confidence and control. Built on secure, cloud-based infrastructure with role-based access controls and SOC 2 Type II accreditation, Labbit ensures your data remains protected while maintaining the integrity and transparency required in highly regulated lab environments.

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Getting Started

See how Labbit works for labs like yours

Book a 30-minute demo to see visual workflow modeling, real-time execution visibility, and knowledge graph insights in action. We'll show you how Labbit adapts to your specific workflows — without the vendor lock-in.

Frequently Asked Questions

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What is a diagnostic testing LIMS?

A diagnostic testing LIMS manages the workflows, sample tracking, and results review that clinical and commercial diagnostic laboratories depend on to produce accurate, defensible, and compliant results.

What should I look for in a molecular diagnostic LIMS?

A strong molecular diagnostics LIMS should model complex, branching NGS or PCR-based workflows natively, maintain 21 CFR Part 11 compliant audit trails, and integrate cleanly with lab instruments and adjacent systems like LIS, EMR, and CRM platforms.

How does a LIMS support CLIA and CAP compliant laboratories? 

Labbit helps CLIA and CAP-compliant laboratories maintain control over diagnostic workflows through configurable processes, complete audit histories, approval workflows, and traceability across samples, results, and activities. By embedding quality and review steps into laboratory workflows, Labbit helps teams demonstrate how work was performed and maintain the documentation needed for inspections and quality processes.

Can a LIMS integrate with existing lab instruments?

Yes. Labbit can integrate with laboratory instruments and connected systems to help automate data exchange and reduce manual data entry. Through flexible integration options, laboratories can connect instruments, automation platforms, and other systems while maintaining a complete view of samples, results, and workflow activity.

Can a LIMS support both NGS and PCR workflows?

Yes. Labbit supports complex molecular diagnostics workflows, including NGS and PCR-based testing processes. Its flexible workflow configuration allows laboratories to model different testing methods, manage evolving assay requirements, and maintain relationships between samples, processes, instruments, and results within a single system.