Sponsored Content MOLECULAR DIAGNOSTICS Q&A
The Importance of Innovation in Molecular Diagnostics
An Interview with Fernando Beils, Vice President and General Manager, qPCR Instruments, Thermo
Fisher Scientific In this interview we discussed the Applied Biosystem QuantStudio Real Time PCR Ecosystem and Thermo Fisher Scientific’s commitment for innovation for molecular diagnostics. Fernando joined Thermo Fisher Scientific in 2018 as vice presi-
dent and general manager of toxicology, therapy drug monitoring, and quality controls after more than 20 years holding a number of leadership roles at Siemens Healthineers. In 2022, he began supporting qPCR instruments as part of Genetic Sciences. After obtaining his MBA in Germany, Fernando held several positions in strategy, finance, operations, and sales and marketing in medical imaging, in vitro diagnostic (IVD) point of care (POC), microbiology, and molecular diagnostics. Overall, IVD tests influence about 70% of all clinical decisions
and they amount to about 5% of the healthcare costs, Beils said. He further discussed the importance of molecular diagnostics and the role that Thermo Fisher had in the industry in this executive interview with the Medical Laboratory Observer editorial team.
Can you discuss the importance of innovation in molecular diagnostics and the role Thermo Fisher
plays in the MDx industry? Molecular diagnostic testing moved to the forefront of present-day clinical practice and through the pandemic gained attention and acknowledgment in public health. Real-time PCR (qPCR) evolved to be the gold standard in infec-
tious disease testing—with further evolution over next-generation sequencing (NGS) into digital PCR, which allows you a powerful combination to monitor and treat patients suffering with cancer. We play a role being the market leader in PCR technologies,
offering microarray (MA), capillary electrophoresis (CE), NGS, and POC in decentralized testing. We cover all aspects through technology, tests, key components, and ingredients to provide superb patient care for the clinical research community. We enable optimal workflow operations, with error elimination, in a fast and safe manner supporting our customers to save time and cost.
How is Thermo Fisher’s commitment to innovation
translating into new products this year? After the launch of our solution for digital PCR, the Applied Biosystems™
QuantStudio™ Absolute Q™
ensured the compliance of the Applied Biosystems™ product family: the QuantStudio™ the flagship QuantStudio™
Digital PCR System, we QuantStudio™
5 Dx Real-Time PCR System and
IVD regulations in both the US and EU. Furthermore, this summer we launched the new Applied Biosystems™
Can you explain the importance of IVDR compliance and how Thermo
Fisher is addressing this need? The EU made the decision to move toward new standards of regulation for
www.thermofisher.com
7 Pro Dx Real-Time PCR System with Diomni™
Software, an
ecosystem which stands also in compliance with IVD regulations in the US and In Vitro Diagnostic Regulation (IVDR) in Europe.
QuantStudio 5 Dx and QuantStudio 7 Pro Dx Real Time PCR Systems and Diomni Software are for In Vitro Diagnostic Use.
The QuantStudio Absolute Q system is For Research Use Only. Not for use in diagnostic procedures.
medical devices. The IVDR is built around providing patient safety with reliable results. This translates that IVD equipment providers need a safe and reli- able workflow and data inter- pretation to ensure that the results of molecular diagnostic tests are supporting patient safety and data privacy. We therefore adapted our flagship instruments to meet this new standard and took into account that the movement of data is IVDR-safe. Diomni Software is also compliant with the IVDR standard.
Fernando Beils
Vice President and General Manager qPCR Instruments
Can you tell us more about the buzz around the
Diomni Software ecosystem? It is about the digital customer experience. Diomni Software is intelligent, integrated qPCR software – accessible and run by your browser. It offers multi-unit and fast qPCR workflows with innovative and AI-powered applications. It speeds up your routine and provides actionable qPCR-based results to enhance healthcare delivery and outcomes. Besides diagnostics, Diomni Software is also addressing the needs in research, academia, and pharma/biotech to improve the workflow and control your data. For clinical applications, in a nutshell, Diomni Software is
about simplifying and accelerating your workflow to clinical results—reducing time, cost, and errors, and protecting your data. Quality control is a major focus. Diomni Software future- proofs the laboratory and is also scalable while being compliant with the regulatory standards. Diomni Software empowers you to trace and track all your samples through the qPCR work- flow from the patient, over liquid handling, sample prep, qPCR analysis, and automation of results, up to the integration into the laboratory information system (LIS). You can connect as many instruments as you would like with one single entry point. Through the efficiency of Diomni Software, you are also reduc- ing the carbon footprint and making more space in your lab.
Thinking about the future—is Diomni Software
targeting only qPCR workflows? We foresee that Diomni Software will include further elements of molecular diagnostic technologies like sequencing, NGS, and microarray analysis, and could expand even further into immunochemistry and LC-MS. Diomni Software is aiming to provide all intelligence to support our partners and custom- ers – ultimately to enable them to make this world healthier.
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