Molecular Information Management Systems (MIMS) Are Newest Tools to Help Clinical Laboratories Perform and Report Molecular and Genetic Test Results
Some experts consider MIMS to be the classic LIS on steroids because they are designed to handle the vast amounts of data generated by the latest generation of genetic tests
Steady improvements to next-generation genetic sequencing, lab-on-a-chip technologies, and lab automation are triggering substantial increases in the volume of data generated at medical laboratories and pathology groups. The future of personalized medicine lies just as much in the analysis of the data generated by these tests as it does in how labs perform these procedures.
Laboratory Information Systems (LIS) help to manage and organize much of this data. However, over the past decade, the volume of data generated by molecular and genetic testing has outpaced the organization, reporting, and interfacing features of popular LISs. With more than 3-billion base pairs of DNA in the human genome, each sample analysis has the potential to generate huge amounts of data.
Clinical Laboratory Industry Advances Outpaced Traditional Lab Capabilities
Particularly in the past 10 years, advances in molecular diagnostics and genetic testing outpaced the capabilities of traditional laboratory information systems. And, because during most of this time, it was typically a handful of medical laboratories that performed advanced molecular and genetic testing, this market was not big enough to justify IT companies developing more sophisticated LIS products to serve what was, at that time, a small market segment.
Consequently, for the past 15 years, clinical labs that developed and performed sophisticated molecular and genetic tests often found it necessary to create their own software code to support their unique menus of tests. It was not an ideal situation, because in-house software solutions had their own problems with interfacing to other lab software, working with lab automation, and supporting QA/QC.
This doesn’t account for outreach, billing, and other administrative considerations. With the shift toward bundled payments and diminishing service reimbursements, molecular and genetic testing labs will need LIS products that competently perform these functions in coming years.
MIMS Enables Labs to Handle Growing Volume of Molecular and Genetic Tests
Meanwhile, what has changed in the molecular and genetic testing marketplace during the past 48 months is the availability of more multi-analyte assays, load-and-walk-away analyzers, and automation that enable pathology groups and community hospital labs to establish and offer a growing menu of molecular assays and genetic tests. Today, the number of labs performing such tests represents a substantial proportion of the lab testing market. And that number continues to grow.
To meet the demand for laboratory information systems that competently and capably manage the high volume of data generated by the current generation of molecular and genetic tests, most LIS providers and vendors are scrambling to add capabilities to their traditional LIS products. Despite this, some experts say progress in improving systems lags behind the need of laboratories for more robust LIS capabilities.
To meet these needs, medical labs performing molecular and genetic tests are turning to new best-of-breed solutions known as Molecular Information Management Systems (MIMS) to help streamline and manage laboratory workflows, reporting, billing, and other essential aspects of daily operation.
These software products are designed to enable labs to handle the growing volume of molecular and genetic data that powers personalized medicine. By design, they have capabilities that go beyond the traditional LIS products, mostly because of the often huge volumes of raw data they must collect, store, and analyze.
In addition, best-of-breed MIMS software must do more than help manage data within the clinical laboratory environment. These systems must support the lab’s workflow—such as how automated systems perform—while handling the transmission and communication of said data to physicians and patients in ways that help drive clinical decisions.
Data Becoming Cornerstone of Modern Pathology and Laboratory Testing
In an article in Advance for Laboratory Administrators, CEO Lisa-Jean Clifford, CEO of Psyche Systems, notes, “The multiple facets of molecular pathology testing can be incorporated into the business of the laboratory. Having the right LIS in a lab that offers these services to their providers enables that lab to capture the tests, results, and codes necessary to thrive as this molecular pathology trend continues to grow.”
One key to this newest generation of LIS is a more robust database capability. “A flexible LIS designed to incorporate all clinical, pathology, molecular, and billing information in a single database will differentiate a laboratory from its competition and ensure long-term profitability and a positive effect on its overall financial health,” observes Clifford.
“Similarly, newer molecular information management systems coming to market have functions and capabilities that differentiate themselves from the classic LIS products that were developed to support the need of the traditional medical laboratory that was performing the standard menu of chemistry, immunoassay, hematology, and other types of tests during that era of the 1990s and 2000s,” she continued. “A full-featured MIMS is programmed specifically to accommodate increasingly complex molecular and genetic assays that contain tens, hundreds, and thousands of analytes. These MIMS must then help lab scientists analyze the data and create the reports that are transmitted to the ordering physicians.”
Written by Mark Terry, a member of the Association of Health Care Journalists and the Association of Genetic Technologists, the white paper explains how MIMS systems help laboratories to overcome the limitations of existing LIS systems when working with the large data sets created by genetic sequencing, molecular assays, and other common lab procedures.
The white paper also discusses important considerations for any clinical laboratory planning to implement MIMS software, as well as methods for comparing features among vendors and providers. Lastly, the report forecasts challenges MIMS software and laboratories might face in coming years as personalized/predictive medicine continues to evolve.