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laboratory informatics


maintenance, personnel competence and even training, adds Clinton Maddox, VP of technical operations. ‘Tis comprehensive overview provided by a single system offers the ability seamlessly to evaluate any aspect of quality, efficiency and cost effectiveness that may ultimately inform on pinch points, competitiveness and sustainability.’


Genealogical model to track workflows Te pMDx platform harnesses a genealogical model to track samples, processes and workflows, Harten explains. ‘You take a specimen and derive your samples from that, and then the system automatically follows the hereditary trail at each step, by tracking what is in every tube and every plate or well, and what has been done to that sample or product, at each stage, and by whom.’ And because the quality of an ancestor


will determine the quality of a descendent, this genealogical approach provides two key capabilities, stresses Harten. ‘If we find that there is an issue with the original specimen, and it needs to be withdrawn, then we can also locate and pull each of that specimen’s descendants – which may potentially now be located in hundreds or potentially thousands of wells and tubes.’ Tis global capacity to track and interrogate


every stage of complex processes in the molecular laboratory means that users can comply with the most rigorous of regulatory requirements, including CAP, CLIA, 21.CFR.11 and others, when handling patient samples and data, comments Chris Harmston, director of quality and compliance: ‘At the heart of that capability is automation. It is nigh on impossible to carry out the level of traceability required, without solid automation underpinning that informatics infrastructure, to ensure that nothing is omitted, and to minimise opportunities for user error.’


Sitting in the Google cloud UNIConnect has established pMDx as a HIPAA compliant, Google cloud-hosted platform, to maximise security for laboratories that are handling patient specimens and


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confidential information. ‘Te security offered by the Google infrastructure is generally far superior to anything that an organisation can implement in house,’ Maddox notes. ‘Everything is maintained and backed


up in the Google application and database servers, and communications are open only between those two servers, with portals for recognised users, backed by industry-standard encryption and authentication protocols for all communication between users and log-ins to the system. Tere are also several levels of granularity as far as permissions are concerned, which means that communication of data about individual patients to and from


THE PMDX


PLATFORM HARNESSES A GENEALOGICAL MODEL TO TRACK SAMPLES, PROCESSES AND WORKFLOWS


individual physicians passes through a check and approval process. Secure portal access extends to all partner laboratories, sales teams and billing partners.’ Te inherent configurability and flexibility


of pMDx means that the platform can also keep pace with changing business and technologies, Maddox points out. ‘New molecular technologies and assays


are being developed all the time. With the UNIFlow Process Definition Language that


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underpins the pMDx suite, we can design and configure new control processes at the same pace as the industry is developing and deploying new assays and technologies and, more importantly, at the pace our clients require. Tis ability is critical from methodological, competitive and regulatory perspectives.’


Empowering clients to configure UNIConnect aims to continue to improve the adaptability and configurability of its platforms for the fast-moving molecular diagnostics and NGS environment, Hull stresses. ‘We equip our clients with the ability to configure our systems to become their systems, and we are working hard to make it practical for them to configure on their own and thus navigate on their own.’ ‘Te comprehensive pMDx LIMS Suite is


designed to support the science and business of precision medicine,’ concludes Rick Mandahl, VP of business development. ‘From small lab to global enterprise we adapt and scale to meet our clients’ changing needs. It is no longer necessary to force-fit approaches that were designed for other purposes. Te pMDx LIMS Suite enables clients to achieve the dynamic objectives of “omic” science and industry with deep laboratory process management and the ability to capture the full dimensionality of molecular operations – from the lab, through the enterprise, to the end client.’l


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