CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
December 2016—As personalized and predictive medicine have progressed from not-in-my-lifetime to now available, health care information technology vendors have faced the challenge of how to manage a mass of molecular data and direct molecular testing processes. CAP TODAY asked vendors of molecular diagnostics lab information systems to explain what their products contribute to the flourishing field of molecular testing. Here are their responses.
Callahan
Chris Callahan, general manager of GeneInsight, a Sunquest company: UniConnect LC, which was recently acquired by Sunquest Information Systems (see “Newsbytes,” page 60), designed the Precision Molecular Diagnostics, or pMDx, laboratory information management system platform to meet exacting molecular diagnostics laboratory requirements for complex data handling and deep process management.
The recent integration of UniConnect’s pMDx solution with Sunquest’s GeneInsight genetics information system provides a molecular and genetics platform that manages workflow from instrument to electronic medical record.
PMDx offers the following.
- Integrated molecular wet lab and dry lab functionality via pMDx and GeneInsight.
- Elimination of spreadsheets and paper with workflow automation from accessioning through extraction, quantitation, polymerase chain reaction, analysis, and final report.
- Installation as a standalone LIMS platform or as software that augments existing clinical lab information systems with rigorous molecular functionality. It is also available via HIPAA-compliant cloud hosting, which provides secure Web portal access for external users, including ordering physicians, partner laboratories, sales teams, and billing partners.
- Billing interface with multiple third-party systems, including Quadax, Premier Source, and Xifin.
- Scalability to meet business growth.
- Graphical dashboards that present real-time information display of desired data sets, tracking every aspect of the science and business, and that are accessible only through adherence to stringent user-access guidelines.
- Custom applications for next-generation sequencing, pharmacogenomics, companion diagnostics, molecular toxicology, oncology, virology, infectious disease, and cytogenetics—commercial or laboratory-developed tests.
- Biobank sample tracking with precise sample location and dynamic visual search.
- Compliance support for industry standards, guidance, and regulations.
- Functionality to track and qualify reagents (including new lot validation, as required per the CAP), instruments, other consumables, and personnel.
Fehrs-Battey
Amber Fehrs-Battey, senior product specialist, Sunquest Information Systems: Sunquest Information Systems offers solutions to help clients maximize the efficiency and quality of their esoteric laboratory testing, in part through complex workflow management, data analysis, inventory management, and data sharing. The solutions also manage polymerase chain reactions, sequencing, karyotyping, DNA and RNA extraction, chromosomal microarrays, and next-generation sequencing.
Sunquest’s molecular and genetics solution, which includes the GeneInsight, UniConnect, and Sunquest Molecular suite of products, addresses many types of workflows, including those for molecular genetics, molecular microbiology, cytogenetics, human leukocyte antigens, and anatomic pathology. The products can track samples and containers. They also manage inventory and interface with instruments and robotics, as well as manage the millions of data points associated with complex NGS and microarray variants.
For health care entities that want to bring testing in-house, Sunquest’s bioinformatics staff provide expert services, including complex secondary and tertiary validations.
Furthermore, Sunquest provides several out-of-the-box tests and system features, such as single and multiplexed PCR, generic Sanger sequencing, NGS, and microarray protocols, which speed implementation and support customization.
GeneInsight, a Sunquest company, manages the analysis of complex genetic data and has been doing so for more than a decade within CLIA-accredited laboratories. GeneInsight has supported the interpretation and reporting workflow for more than 50,000 clinical reports. The platform integrates with Sunquest’s molecular laboratory solutions to pull data from next-generation sequencers and chromosomal microarray instruments, their accompanying software, or bioinformatics systems. From there, complex genomes are processed using filtration, annotation, analysis, reporting, and clinician tools.
In addition, GeneInsight participates in variant data-sharing working groups to establish new standards for genetic data throughout the medical community. Among the large national data-sharing initiatives that use the company’s systems are the Canadian Open Genetics Repository and eMERGE (Electronic Medical Records and Genomics) Network.