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Supporting Innovation: How LigoLab Empowers Labs to Develop and Validate Their LDTs
January 5, 2026
Editor’s Note: Even though a March 2025 ruling in a U.S. district court went against the FDA's plans to regulate lab-developed tests more closely, it’s good to know that modern laboratory information system software (LIS systems) offer powerful clinical and pathology lab software solutions to manage LDT workflows with flexibility, speed, and precision. The best LIS systems feature fully configurable tools that support custom assay development, validation, quality control, real-time analytics, and regulatory documentation, enabling labs to stay inspection-ready, streamline operations, and respond quickly to evolving clinical and regulatory demands.
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How LigoLab’s Modern LIS System Tools Fully Support LDTs
As laboratory-developed tests (LDTs) become increasingly essential to personalized medicine and cutting-edge diagnostics, medical labs are turning to technology partners that foster innovation while maintaining strict regulatory compliance.
LigoLab’s all-in-one laboratory information system (LIS) platform with an embedded lab revenue cycle management (lab RCM) module stands out as a transformative pathology software solution because it enables labs to confidently design, validate, and manage their LDTs with agility.
LigoLab’s advanced LIS lab platform features fully configurable workflows, real-time analytics, and robust compliance tools, delivering the flexibility and laboratory information system functions needed to meet today’s complex testing and regulatory demands.
Join us as Jenny Bull, LigoLab’s Success Director, with 26 years of laboratory operations experience overseeing anatomic pathology, molecular, cytology, clinical, laboratory revenue cycle management (lab billing), human resources, quality, and finance departments, takes us on a detailed tour of the LigoLab platform and provides examples of how the best laboratory information system software supports tests developed and validated by an individual lab.
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Custom Lab Workflow Configuration for LDTs
A core differentiator of LigoLab’s LIS system software is its ability to empower laboratory staff with complete autonomy in developing and managing LDT workflows.
Empowering Labs With Complete Assay Configuration Independence
“LigoLab equips labs with a user-friendly, fully configurable LIS system and lab billing tools to create, modify, and manage assays independently,” explained Bull. “This flexibility enables laboratory teams to define workflows, build reflex and result logic, establish quality control (QC) parameters, and customize report outputs, without waiting on vendor assistance.”
By placing this level of control directly in the hands of lab personnel, LigoLab significantly accelerates the time-to-launch for new tests and enables laboratories to adapt quickly to evolving clinical demands and regulatory requirements.
Configurable LDT Workflows With Built-In Version Control and Auditability
“LigoLab provides configurable tools that enable laboratories to design and refine result formats, reflex testing logic, and validation workflows tailored to the specific requirements of each LDT,” Bull added. “Dynamic result reporting and rule-based LIS system automation help ensure accuracy while maintaining regulatory alignment.”
To support reproducibility and compliance, every modification is captured through built-in version control and comprehensive audit trails. “LigoLab tracks every change made to test configurations, workflows, and reports,” said Bull. “Each update is logged with timestamps, user identification, and detailed change records, delivering full transparency, traceability, and accountability.”
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Validation and QC Support
LDTs require rigorous validation to ensure clinical reliability and regulatory compliance. LigoLab supports this with custom validation protocols, automated data capture, and real-time analytics, all of which reduce manual entry and minimize errors.
With built-in clinical and pathology lab management tools for evaluating precision, linearity, and accuracy, a lab’s validation process becomes faster and more reliable.
"LigoLab enables laboratories to define and apply quality control (QC) rules specific to each test’s performance characteristics," Bull continued. "The LIS system actively monitors QC data in real time and automatically flags exceptions or out-of-range values."
This QC oversight is complemented by seamless data storage to support FDA submissions.
"The LIS system ensures completeness, consistency, and traceability through a structured data architecture," noted Bull.
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Integrated Reporting and Data Management
Clear, configurable reporting is essential for effectively communicating LDT results and supporting clinical decision-making. LigoLab’s dual reporting engines accommodate both narrative and structured formats while enabling advanced logic to support complex diagnostic workflows.
“LigoLab’s dual reporting engines support reflex testing logic, conditional formatting, and interpretive comments that enhance clinical value and improve report clarity,” said Bull.
All test data, quality control metrics, and validation documentation are centralized within the LIS lab platform, streamlining audits, inspections, and internal reviews. “This unified data environment simplifies internal reviews by providing immediate access to both historical and real-time information,” Bull explained. “By eliminating data silos, medical laboratories reduce errors and improve overall operational efficiency.”
Real-time analytics also enable continuous performance monitoring and faster issue resolution. “LigoLab’s real-time analytics deliver instant visibility into laboratory operations,” said Bull. “Customizable dashboards and reports help teams quickly identify bottlenecks and take corrective action before issues impact turnaround time or quality.”
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Compliance and Documentation
Navigating CLIA, CAP, COLA, TJC, and FDA requirements is complex and time-consuming, but LigoLab helps laboratories shoulder much of the regulatory burden through built-in compliance automation.
“LigoLab automates the collection, storage, and retrieval of critical data required by accrediting agencies,” said Bull. “This streamlined approach reduces manual errors and significantly improves regulatory readiness.”
LigoLab’s all-in-one laboratory information system software further supports inspection preparedness with electronic signatures, comprehensive audit logs, and role-based access controls that safeguard data integrity. “The platform streamlines the entire qualification lifecycle by providing built-in tools and templates for design qualification (DQ), operational qualification (OQ), and performance qualification (PQ),” Bull noted.
During DQ, laboratories can clearly trace test requirements and intended use. The OQ phase leverages HL7 simulation and security validation to confirm LIS system functionality, while PQ ensures production readiness through real-world sample testing and end-to-end system validation.
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Collaboration & Flexibility
LigoLab’s comprehensive and flexible medical LIS platform with embedded and advanced laboratory billing solutions enables a seamless workflow from test order to the RCM cycle, an essential consideration for complex LDTs.
"The platform tightly integrates technical operations with the laboratory billing process," explained Bull. "It ensures accurate charge capture and automatically applies the correct CPT codes and lab billing edits based on test type and payer requirements."
For multi-site laboratories and research institutions, the LigoLab platform delivers centralized management for both pathology and clinical laboratory operations. "Role-based access controls, secure internal messaging, and audit logging ensure operational integrity across distributed environments," said Bull.
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LigoLab: Your Strategic Partner in LDT Innovation, Compliance, and Growth
By delivering full control over LDT workflows, integrated validation tools, advanced reporting capabilities, and robust compliance tracking, LigoLab empowers forward-thinking clinical laboratories and pathology groups to innovate with confidence, without sacrificing quality or regulatory alignment.
“LigoLab is an innovation partner, equipping laboratories with the tools they need to address today’s challenges while preparing for tomorrow’s opportunities,” said Bull.
For laboratories committed to advancing diagnostic science, LigoLab provides a strategic advantage that drives growth, streamlines operations, and ensures compliance at every stage of the testing lifecycle.
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A Unified Medical LIS & Lab RCM Platform Built for Modern Laboratories
LigoLab is a leading provider of integrated laboratory information systems and laboratory revenue cycle management software designed to streamline operations, reduce complexity, and improve profitability for medical laboratories.
Since 2006, LigoLab has delivered a comprehensive informatics platform that unifies every aspect of laboratory operations, from order entry and specimen processing to compliance, reporting, and laboratory billing, within a single, scalable LIS lab solution.
Purpose-built for clinical, reference, molecular, and anatomic pathology laboratories, the LigoLab platform combines advanced automation, highly configurable workflows, and intelligent business tools to enhance speed, accuracy, and regulatory compliance. By eliminating siloed diagnostic lab software systems and manual workarounds, LigoLab enables laboratories to reduce errors, accelerate turnaround times, and maintain full regulatory alignment.
Supported by hands-on customer service and a strong commitment to continuous innovation, LigoLab has earned the trust of laboratories seeking a long-term technology partner focused on delivering high-quality diagnostics and sustainable growth.
Ready to Modernize Your Laboratory Operations?
Discover how LigoLab’s unified medical LIS & lab RCM platform can help your lab streamline workflows, eliminate complexity, and improve profitability, all without compromising compliance or quality. Contact a LigoLab product specialist today to schedule a personalized demo and see how a truly integrated informatics platform supports long-term growth.
