Supporting Innovation: How LigoLab Empowers Labs to Develop and Validate Their LDTs

Editor's Notes: 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 laboratory management 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.

Related Link: Dark Daily - Three Possible Scenarios for LDT Regulation after Historic Court Decision Vacates FDA Final Rule

How LigoLab’s Modern Laboratory Information 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 (RCM) module, stands out as a transformative diagnostic lab software solution by enabling 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 required 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 LIS workflows, 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 individual labs.

Discover More: Laboratory Information Systems Are Not Commodities!

Custom Lab Workflow Configuration for LDTs

A core differentiator of LigoLab's advanced LIS software is its ability to empower laboratory staff to develop and manage LDT workflows with complete autonomy.

Empowering Labs With Complete Assay Configuration Independence

“LigoLab equips its customers with a user-friendly, fully configurable LIS system with 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 rules-based lab information 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," continued Bull. "Each update is logged with timestamps, user identification, and detailed change records, delivering full transparency, traceability, and accountability."

Discover More: Best LIS Software - Maximize Growth With Cutting-Edge Pathology Lab Management Software

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 assessing precision, linearity, and accuracy, laboratories can streamline validation while improving consistency and reliability.

“LigoLab enables laboratories to establish and apply quality control (QC) rules tailored to the performance characteristics of each test,” said Bull. “The LIS system continuously monitors QC data in real time, automatically identifying exceptions and flagging results that fall outside established parameters.”

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.

Discover More: A Detailed Look at How Modern Laboratory Information Systems Fully Support Quality Control

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, which manage report structure and result templates,  support both narrative and structured formats while enabling advanced logic for complex diagnostic workflows.

"The 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. 

"The analytics deliver instant visibility into laboratory operations, and customizable dashboards and reports help teams quickly identify bottlenecks and take corrective action before issues impact turnaround time or quality," she said.

Discover More: Understanding the Importance of Real-Time Analytics in the Modern Clinical Laboratory

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.

Discover More: Automate Complex Processes & Simplify Clinical Lab Operations with LigoLab Informatics Platform

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, 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.

Discover More: Six Reasons Why You Should Choose an Integrated Laboratory Billing Solution for Your Medical Lab

LigoLab: Your Strategic Partner in LDT Innovation, Compliance, and Growth

By delivering full control over LDT workflows, integrated validation tools, advanced reporting, 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 customers 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 by driving growth, streamlining operations, and ensuring compliance at every stage of the testing lifecycle.

Industry Insights: Empowering Laboratories - The Benefits of Full Agency Over LIS System Configuration

A Unified Medical LIS & Lab Revenue Cycle Management 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, the LIS company 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 lab organization software 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.

Backed by responsive, hands-on customer support and a commitment to continuous innovation, LigoLab has earned the trust of laboratories looking for a long-term technology partner that supports high-quality diagnostics, operational excellence, and sustainable growth. 

Ready to Modernize Your Laboratory Operations?

Discover how LigoLab's unified medical LIS & lab revenue cycle management platform can help your business 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.

Act Now: Speak with a LigoLab Product Specialist!

Frequently Asked Questions About LigoLab's Support for LDTs

What is a laboratory-developed test (LDT)?

An LDT is a diagnostic test designed, validated, and performed by an individual laboratory rather than by a commercially manufactured kit. It plays an increasingly important role in personalized medicine and specialized diagnostics.

How does LigoLab let labs manage LDT workflows independently?

LigoLab's configurable LIS system and lab billing tools allow labs to create, modify, and manage assays on their own, defining workflows, reflex and result logic, QC parameters, and report outputs without waiting on vendor assistance.

How does LigoLab support version control and auditability for LDTs?

Changes to test configurations, workflows, and reports are (automatically) logged with timestamps, user identification, and detailed audit records, providing complete transparency and traceability to support reproducibility and regulatory compliance. 

What validation and quality control tools does LigoLab offer for LDTs?

LigoLab supports custom validation protocols, automated data capture, and real-time analytics to evaluate precision, linearity, and accuracy, along with QC rules that monitor data in real time and automatically flag out-of-range values.

How does LigoLab support FDA submissions and regulatory documentation?

The platform’s structured data architecture helps ensure validation data remains complete, consistent, and fully traceable while automating the collection, storage, and retrieval of information required to support compliance with accrediting and regulatory organizations such as CLIA, CAP, COLA, and TJC. 

What qualification tools does LigoLab provide for LDT validation?

LigoLab offers built-in tools and templates for design qualification (DQ), operational qualification (OQ) using HL7 simulation and security validation, and performance qualification (PQ) through real-world sample testing and end-to-end system validation.

How does LigoLab integrate LDT testing with laboratory billing?

The platform tightly connects technical operations with lab billing, automatically applying the correct CPT codes and billing edits based on test type and payer requirements.