Precision medicine is revolutionizing the way we approach modern healthcare by offering medical treatment customized for an individual patient. Medical decisions can now be tailored, or ‘personalized’ to an individual based upon predictions relating to therapeutic responses or risk of disease. Molecular diagnostics enables this novel approach to healthcare through the analysis of an individual’s genetic code and resulting protein expression profile. This rapidly advancing field allows for the determination of a person’s risk for certain diseases through the detection of biomarkers. Molecular diagnostic tests also serve to better inform the selection of targeted therapies and to subsequently monitor the effectiveness of the treatment based upon the resulting changes in the biomarkers.

Until now, informatics solutions required to effectively support the accelerated advancement of precision medicine were not commercially available. With the introduction of the L7|ESP Enterprise Science Platform™ from L7 Informatics, diagnostic organizations are able to use a single platform for complete end-to-end assay automation and complex data management across the entire workflow. L7|ESP digitizes data, automates processes, and manages the patient precision medicine journey across various silos such as patient consent management, specimen collection, sample preparation, wet lab processing, NGS sequencing, and advanced informatics (including bio-informatics/AI & ML), diagnostic decision support, outcomes tracking, disease registries, and clinical trial management.

In a recent interview with Dr. Erica Tennenhouse, managing editor of Clinical Lab Manager¹, Dr. Vasu Rangadass, President and CEO of L7 Informatics,  shares his vision on how the L7|ESP integrated data management platform can support diagnostic laboratories by breaking down data silos to achieve operational excellence.

Q: What are the greatest informatics challenges that diagnostic labs face today?

A: I think the number one problem that we see is data silos. Typically, the more advanced diagnostic labs have their own home-grown system because they didn’t see any viable solution in the market. As genomics medicine becomes standard of care, especially in the treatment of cancer and rare diseases, we see molecular diagnostics growing rapidly. You want fast turnaround times and accurate audit trails and full data provenance. All of that is not easy to do when you have siloed systems and paper intermixed with Excel spreadsheets.

Q: How is L7’s Enterprise Science  Platform solving these challenges?

A: Traditionally, people use LIMS systems to manage the wet labs and then they use bioinformatics pipelines to manage the informatics analytical pipelines. L7 was created to break down this wall and create one integrated platform. We’ve now expanded our scope beyond breaking down this one wall between wet lab and dry lab to breaking down walls between sample management, sample accessioning, sample inventory management, reagent inventory management, and freezer or location management. We’ve incorporated all of this into one integrated platform called ESP. It’s kind of like an operating system for the lab with different applications, so it’s a much more modern architecture to support the lab of the future where people don’t have to buy multiple different systems. We created one platform and LIMS just happens to be one app and there’s also an inventory management app and a location management app. Customers can pick and choose what apps they want, but all of the data in the lab, both scientific data and operational data, is in one place. We can support digitization, workflow automation, and all of these other functions because we are a single platform to support all the lab needs.

Q: What prevents all labs from adopting an integrated data management system?

A: I think the main bottleneck is that customers already have an existing system. But even customers with existing systems are looking to use ESP as an overlay system on top of their siloed systems to tie all of their siloed systems together. ESP can replace existing legacy systems or overlay on top of those systems and give them a big-picture view of the entire lab. We have customers that are using it in both modes.

Q: What types of diagnostic labs stand to benefit most from your platform?

A: Molecular diagnostics labs—so people doing qPCR for COVID testing or whole genome sequencing for rare diseases or RNA sequencing for cancer or exome sequencing. It’s really all the molecular diagnostics that we are focused on because they are the ones that have the most complexity. But that doesn’t mean that our system is only useful for molecular diagnostic companies; I think we can support any diagnostic. Our system is also fully regulatory compliant, so our customers are using this not only for molecular diagnostics and companion diagnostics but also for manufacturing quality control and manufacturing automation. We have customers both in the precision diagnostics space and also in the cell and gene therapy space using this for doing quality control and manufacturing execution

Conclusion

Precision Medicine is rapidly becoming the new frontier for the future of healthcare. Molecular diagnostic testing is enabling customized approaches to support more effective treatments targeting the personalized needs of individual patients. To help diagnostic testing organizations overcome the challenges brought about by the increasing need to automate workflows, manage large volumes of data, and meet stringent regulatory compliance requirements, the L7|ESP platform provides the innovative tools needed to meet the demanding requirements of today’s diagnostic laboratories.

Why it Matters for You?

Through the elimination of legacy data and process silos, l7|ESP enables the diagnostic laboratory to increase reproducibility and efficiency while decreasing errors and turnaround time to achieve operational excellence.

• Breaks down data silos through integrated data management strategy
• Automates and streamlines all the workflows and data capture across the clinical pathway
• Achieves regulatory compliance requirements: CAP/CLIA/cGMP/CFR part11 and HIPAA
• Integrates with scientific instruments, medical devices, imaging systems, EMR, ERP, lab informatics, and digital pathology systems
• Provides end-to-end tracking of the patient treatment with complete audit and decision support capabilities
• Allows for better collaboration between researchers, physicians, nurses, informaticians by placing them on a single operational platform with full audit capabilities
• Expedites queries about the patient treatment status, by keeping all your data in a cross-referenced single repository
• Provides reliable and easily accessible data documentation to facilitate accurate submissions for regulatory approvals

About Astrix:

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.  With over 25 years of industry proven experience, Astrix has the informatics specialists and business process analysis tools required to develop and implement the solution that works best for your enterprise. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey, connecting people, processes and systems to accelerate the advancement of science and medicine.

¹E. Tennenhouse, “Breaking Down Data Silos in the Lab”, Oct. 22, 2020, Breaking Down Data Silos in the Lab | Clinical Lab Manager , Clinical Lab Manager, accessed Feb 9, 2021.