February 10, 2021
Rapid advances in next-generation sequencing (NGS) have revolutionized the study of genomics and molecular biology, enabling scientists to analyze genetic variants that are associated with diseases. While novel technologies such as NGS have opened the door to new, targeted approaches to precision medicine, next-generation diagnostics companies are struggling to effectively manage complex processes, large volumes of data, and the task of integrating wet lab analysis across the enterprise.
There is a need for a data and process automation platform that allows diagnostics companies to rapidly setup complex assays and automate the entire “diagnostic order” to “report generation” process and collect all the scientific, quality and regulatory data across the process with full data provenance and audit requirements. L7 Informatics’ Enterprise Science Platform™ (L7|ESP) is a scientific information management (SIM) platform that enables diagnostic organizations to use a single platform for registering and processing samples, running complex analyses, and delivering data to physicians and patients. L7|ESP provides complete end-to-end assay automation and is designed to increase reproducibility and efficiency while decreasing errors and turnaround time.
The Business Challenge
Diagnostics laboratories are faced with many challenges in the effort to digitalize their operations while incorporating advanced technologies such as NGS or AI into their daily workflow:
- Bi-directional integration to various electronic medical records systems in the market
- Lack of real-time visibility to the final report generation so that providers know the expected date of report and plan treatment accordingly
- Complex integrations to new and old instruments across wet lab sequencing and bio-informatics (primary, secondary and tertiary analysis)
- Ability to plan lab resources and manage normal and stat orders on the same system.
- Lack of instrument validation and reagent inventory management that is integrated into the LIMS systems
The L7|ESP Solution
Legacy data and process silos hinder efficiency and science, increasing risk for business and patient. The L7|ESP platform breaks down data silos through an integrated data management approach that delivers a quantifiable business impact:
- Improved regulatory compliance. L7|ESP is a GLP, GCP and GMP compliant platform
- Increased quality of tests performed due to automated SOPs with a seamless integration between wet lab and computer lab
- Improved efficiency, faster turn-around times and lower cost with more efficient utilization of resources and inventory
- Real-time visibility to “where is the sample?” and the status of the “ where is the report?” to internal account teams as well as ordering providers
- Real time integration to Instruments, CRM systems, Ordering systems and EMR systems
- Verification of inventory and instrument readiness prior to test start
- Automated reordering of reagent inventory
- Integrated freezer and location management
The L7|ESP platform provides diagnostic companies with total visibility over all their operations while digitizing, integrating, and automating the entire precision diagnostic workflow. This streamlined approach will dramatically increase sample throughput and quality assurance in results while providing reliable documentation for regulatory review and compliance (CAP/CLIA/GLP/cGMP).
Why It Matters for You
L7|ESP allows you achieve operational excellence by increasing sample throughput and providing better reproducibility while being a fully integrated and automated process.
- Total digitized visibility across all integrated operations
- Break down data silos through integrated data management
- Elimination of manual processes throughout the entire workflow
- Improved data accessibility to better inform research and business decisions
- Comprehensive validation strategy for improved regulatory compliance
- Increase efficiencies to achieve operational excellence across your organization
- Reduced operational costs and faster time to market
By breaking down data silos with the integrated data management approach of the L7|ESP solutions, next-generation diagnostic companies can provide superior diagnostic service, with reliable and easily accessible data documentation for increased confidence in your results and efficient turnaround time.
To maximize the benefit of implementing transformative technology such as the L7|ESP platform within your organization, working with a proven informatics solutions expert is vital to the success of your project.
Astrix is an industry leader in helping scientific organizations implement and integrate new informatics systems in the laboratory since 1995. Our experienced team of expert informatics consultants bring together technical, strategic, regulatory and content knowledge to provide the most effective solutions to problems faced by scientific organizations. Astrix partners with many of the industry leaders in the informatics space to offer state of the art solutions for all of your laboratory informatics needs. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey.