Automating qPCR Workflows for Better Scientific Outcomes

An interview with Wouter Uten, Founder & COO, UgenTec
August 4, 2022
Wouter Uten, Founder and COO, UgenTec

We’ve welcomed UgenTec to the Tetra Partner Network and are eager to share our conversation with Wouter Uten, Founder and COO, UgenTec. 

Please tell us a little bit about yourself.

I am a manager & entrepreneur with a passion for life sciences and the digital revolution within our society. I founded UgenTec in 2014, and as a tech scale-up we quickly became a global leader specializing in automation of molecular workflows in diagnostic, pharma and research laboratories. With our software platform, FastFinder, we use data science, AI and workflow automation tools to optimize and automate the sample flow, data analysis and interpretation, QC, and lab intelligence for PCR based assays and other molecular test modalities.

Briefly, please tell us about UgenTec.

UgenTec is a global molecular laboratory software provider servicing molecular labs & assay and instrument providers across clinical diagnostics, pharmaceutical,  Contract Research Organizations (CROs), crop science, biotech, food safety, veterinary and more.

Our FastFinder product is a modular, clinical grade Software as a Service platform using AI methods allowing labs of all sizes to standardize and automate their molecular workflows. FastFinder’s modules include Analysis, Genotyper, QC, Insights, Studio, and Workflow.

Why did you create FastFinder?

We created FastFinder to address critical workflow and data interpretation issues in PCR molecular testing. Whether in diagnostic testing, therapy development, clinical trials, vaccine and drug development, or screening programs, we see that Pharma, CRO and biotech companies deal with increasing assay complexity, longer validation and verification cycles, larger collaboration networks, and increasingly competitive time-to-market and cost pressure. 

There is an acute and growing need for audit-trailed, standardized, automated lab sample flow support

It's crystal clear to us that there is an acute and growing need for audit-trailed, standardized, automated lab sample flow support – because labs require automation of their PCR molecular testing workflows, standardized & reliable ‘data reduction’, reducing hands-on result review, and strong tracking tools to track QC metrics in real time. Your research projects and studies are only as good as the data you rely on. So we don’t just automate the result calling for PCR (and NGS, serology and Mass Spec workflow automation) – we support the full sample flow across LIMS and instrument connectivity, standardizing data reduction SOPs, QC dashboarding, and integration with existing systems so labs are prepared for multi-omics data fusion.

How does FastFinder work?

FastFinder is intelligent software that tracks samples throughout the workflow, reduces manual steps, connects instruments, ensures that assays are analyzed consistently, provides QC and LabOps dashboards, and cuts result interpretation time in half. It’s designed to handle PCR, Serology, NGS and Mass Spec workflows.

FastFinder works from sample to result - bringing sample flow intelligence to the connected molecular lab. It orchestrates the samples across the lab’s testing workflows, cuts assay result data analysis and interpretation time in half, and produces actionable lab intelligence. Under the hood is smart data science and AI based on millions of results, to optimize the confidence in result calling – and rich feature functionality to automate analysis and reporting with clinical-grade, audit trailed tools.

Under the hood is smart data science and AI based on millions of results, to optimize the confidence in result calling – and rich feature functionality to automate analysis and reporting with clinical-grade, audit trailed tools.

While we support different test modalities, PCR labs are our core market. For any PCR workflow, customers remove manual steps; increase auditability, QC and traceability; automate data reduction and analysis; increase lab throughput, data accuracy and compliance. And lab technicians, molecular biologists, and lab directors love our software interface and ease of use. Instead of costly internal build or refurbishing commercial LIMS systems, FastFinder is  built from the ground up for the molecular lab.

Please tell us more about the customer challenges that you solve for PCR?

We learned a lot from diagnostic labs, and have taken those learnings to our Pharma and CRO customers. There, we see a multitude of challenges come back, but also requirements we think are specific for our customers in the pharmaceutical, CRO, and biotech industries. 

  • There is an increasing need for “data reduction”, i.e. going from raw molecular testing PCR data to yes/no, qualitative/quantitative answers. 
  • As instrument software doesn’t suffice for our customers’ use cases, they’ve traditionally solved this with home-brew scripting and spreadsheets on top of vendor software. This is now impacting time-to-value on testing projects, prohibiting taking validated pipelines to their partners and testing sites, and becoming a maintenance bottleneck and innovation hurdle/time sink for internal teams
  • Across PCR testing initiatives, customers lack of standardization of analysis, interpretation, and results is causing downstream issues on result collation, repeatability, and result call accuracy
  • QC can be an afterthought with vendors, but front and center for pharma. No real-time QC metrics, alerts, & track-and-trace for troubleshooting
  • Existing home-brew or research tools for PCR do not scale, do not support multi-site partnerships, do not translate from R&D into production & routine, and do not scale to volume.

How does UgenTec address this need?

  • Standardization of the “data reduction” workflow, i.e. taking raw PCR data for assays, and going to the “yes/no” or quantitative calls in a structured, traceable, automated, white-box manner – avoiding differences between lab operators, molecular biologists, assays, and importantly – multiple lab sites.
  • Automation of the “high throughput screening” workflow. i.e. taking away as many manual steps as possible, because these introduce opportunities for errors. This is about automatically consuming instrument files, taking in sample lists and work lists, executing the assay decision logic (replicates, positive controls, no template controls, thresholds, combining markers…) – to ensure people, instruments and assays are used at maximum capacity – taking manual review, 4-eye review, and manual data collation out of the picture.
  • QC, We know from our collaborations with pharma partners and CROs that they really appreciate our real-time QC dashboards. With our QC dashboards, pharma labs intervene real-time when QC rules are triggered. They have Levey-Jennings charts on all PCR metrics, and lab intelligence dashboards on top to catch things like control drift, strange instrument behavior or unexpected result rates, … before results go out.
  • Collaboration. In the pharma/biotech space, we see a lot of “multi site” situations, where the lab(s) are at multiple geographic locations – within a country as well as internationally. Pharmas and CROs want to standardize how samples are analyzed and how results are called, and UgenTec’s fastfinder has both the flexibility to represent result calling SOPs, and the “white box automation” tools to represent these in versioned, repeatable, traceable “assay plugins” that guide and govern the standard approaches and SOPs to data reduction and result calling. 
  • Artificial Intelligence. But… provided in a user friendly, accessible way. “Explainable AI” is not just a hot new trend – we implement it day-to-day for hundreds of routine labs. Because we have seen billions of PCR results, support hundreds of labs, and are compatible with all instrumentation, we have the (patented) AI technology to allow result calling to be more accurate than with the instrument vendor software. On our platform, pharmas, CROs and biotechs can optimize their assays beyond simple thresholding and calling algorithms. 

What kind of results have you been able to help your customers achieve?

We're lucky that many customers have been willing to share success stories with us in the form of an application note, a validation study, a white paper, a poster, a talk, or a peer reviewed publication. We’ve put a selection on, and they range from successes with real-time QC, to large scale PCR testing across multiple pharma & lab sites for COVID screening initiatives, to building an assay for complex multiplex HPV screening, to prenatal blood bank testing – alongside many successes in routine clinical diagnostics labs, where QC, audit trails, and compliance are essential. 

What is the value of belonging to the Tetra Partner Network?

We’re very excited to join TetraScience’s partner network – and we’re looking forward to make the sum of the parts greater than the whole, by putting together solutions for our joint customers that will allow them to neatly fold in their PCR workflows into their multimodal, multi-omics studies, with the confidence that they have insights in their PCR lab operations, they are on top of QC in real time, they’re executing their data analysis SOPs according to plan and in a traceable way, and and are in control of the ever more complex result calling and data reduction challenges that come with molecular testing.

How important is Tetra Data, or engineered scientific data, to your workflows and customers?

We strongly believe that pharma and biotech companies benefit greatly when they use the right tools to unlock all the insights that all too often remain hidden in the data sets they build over time. UgenTec excels at providing the right tools to not only automate the routine sample-to-result workflows in day-to-day lab operations, but derive insights from labs’ PCR workflows – and feed into larger downstream data-aggregation efforts, enable multi-omics, facilitate multi-site testing, and connect multi-modal testing technologies.

We strongly believe that pharma and biotech companies benefit greatly when they use the right tools to unlock all the insights that all too often remain hidden in the data sets they build over time.

It's clear that we share this vision with TetraScience, and that TetraData will be a platform that allows pharma and biotech partners to bring together data flows and turn it into informative, actionable insights.

What else would you like to tell us?

We love talking to labs about their data analysis and workflow challenges, so if you’re curious to learn more, please reach out and we’ll talk through your current molecular testing workflow and walk through the software together, and discuss how it fits in your larger pharma data management initiatives – I’m sure you’ll love our platform!

Read the TetraScience / UgenTec Partnership press release