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August 19, 2020
Sponsored by
UgenTec

Case Study: An IVD Manufacturer’s Experience Building a Complete Sample-to-Result Workflow

GenomeWebinar

Vice President, Scientific Affairs, SpeeDx

Senior Field Application Scientist, UgenTec

Business Development Manager, Latin America, Thermo Fisher Scientific

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Data analysis software has become an integral component of in vitro diagnostic assays in general, and molecular diagnostic tests in particular. The ability to provide a software solution for end users that accurately reports results, identifies technical issues, and can be integrated with a laboratory’s information systems can be as important in the final decision about whether to adopt a given platform as analytical and clinical performance data.

Another important consideration for molecular diagnostic development is the decision whether to develop a novel instrument or to leverage a third-party open platform. Considerations not only include size or price, but also the global installed base, available service plans, options for instrument placement and reagent rental. These choices impact capital efficiency, time to commercialization, and accelerated adoption of the assay in the market. 

SpeeDx is a developer of innovative multiplexed molecular diagnostic assays that employ a novel PCR technology (PlexZyme). Although the assay chemistry is flexible and instrument agnostic, the company needed a customizable software application that could take unique data feeds from different instruments and turn them into accurate reportable results with minimal involvement from end users.

This presentation will discuss the partnership between SpeeDx and Ugentec to produce an integrated data analysis solution for SpeeDx customers running the assay on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument , covering the key elements of the Ugentec software. 

After the main presentation, UgenTec will briefly discuss its FastFinder software platform that allows labs and assay providers to build sample-to-result workflows and Thermo Fisher Scientific will briefly introduce its instrumentation, reagent, and services portfolio for assay development. The presentations will be followed by an interactive Q&A session with attendees.

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