Managing the complexity of molecular diagnostics


Sophia Ktori profiles UniConnect, a specialist


provider of informatics software for use in molecular diagnostics


T


he development of sophisticated genomic and proteomic technologies are uncovering the interplay between genes, proteins and disease pathways


– changing the face of therapeutics R&D. A new era in biologics, and the emergence


of diagnostic procedures that marry genotype to disease phenotype, are driving the development of personalised medicine. Tis has led to new requirements for increasingly sophisticated informatics platforms that can manage the procedural, business and regulatory needs of molecular diagnostics (MDx), pharmacogenomics (PGx) and next generation sequencing (NGS) laboratories in both the research and clinical sectors.


Between the bookends For much of the last 20 years, laboratory information management systems (LIMS) have been very much geared to managing


information about a sample or a test that you were working with, capturing the results from that test, and then storing those two facets of information in a database, notes Bill Harten, founder and CEO at Salt Lake City-based UNIConnect. He tells Scientific Computing World: ‘You


took a sample, added a reagent, and detected the outcome. Te industry focus has been on relatively simple, shallow processes that happened in a single tube or well. Tese are the bookends of informatics, and a couple of decades ago there was very little in between those bookends.’ With the advent of molecular science,


however, the need for deep process management ‘between the bookends’ has become both apparent and acute. ‘Yet the conventional LIMS industry had developed


THE CONVENTIONAL LIMS INDUSTRY HAD DEVELOPED PRODUCTS FOR OTHER PURPOSES, AND NOT TO MEET THE NEEDS OF MOLECULAR LABS


products for other purposes, and not to meet the needs of molecular labs,’ Harten maintains. ‘UNIConnect has changed the paradigm.’ Today’s MDx, PGx, plant genomics and


NGS laboratories carry out hugely complex processes. ‘A single workflow may involve 10, 20 or


even 30 generations of tasks, starting with the extraction and amplification of DNA from a specimen,’ Harten continues. ‘From start to finish there may be numerous interconnected workflows that each involve multiple transfers of specimen, sample and products through multiple containers, multiple instrumentation, and multiple personnel. Tis capacity to manage deeply complex workflows isn’t possible with traditional LIMS systems.’ To put it bluntly, as Carl Hull, VP for sales,


notes: ‘If there is one thing that UNIConnect has learned by talking to clients in the molecular diagnostics space in particular, it is that trying to force fit a clinical LIMS into a molecular diagnostics laboratory is a miserable experience.’


Designed by molecular biologists It was this recognition that existing LIMS technologies weren’t geared to the complexity of the molecular biology space that led UniConnect to develop its process management soſtware suite, pMDx (precision molecular diagnostics), as a comprehensive, easily configurable system for MDx, NGS and plant genomics laboratories. ‘pMDx has been designed by molecular


biologists, specifically for molecular biology workflows’, Harten states. ‘It can track and manage the complete round trip of specimen from the physician’s office, to the actionable report delivered back to that physician. Customisable dashboards provide real- time summaries of operations, and tailored reporting templates are built for each client.’ Critically, as well as handling the most


Deep process management has become more important in recent times 16 SCIENTIFIC COMPUTING WORLD


complex and deep workflows in molecular diagnostics, the pMDx solution offers modules that capture all support activities and data, from biobank, inventory and document management, reagent ordering and consumption, to instrumentation


@scwmagazine l www.scientific-computing.com


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