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Dr. Achim von Leoprechting

Scaling healthcare innovation globally.

More innovation, yet more simplicity.
More volume, yet better quality.

 

The last two years have been exceptional, for the world as well as for Tecan. We were called upon to help tackle the first pandemic where lab automation would play a crucial role. And our contribution was decisive in the global response to COVID-19.

But this is only the beginning. We have known for decades that several health challenges need attention beyond infectious diseases, notably cancer, rare and hereditary diseases, metabolic and cardiovascular diseases, among many others. The healthcare challenge will intensify as populations requiring healthcare grow larger and older. Innovations that facilitate early detection, disease prevention and precision therapies provide the prospect of alleviating the burden of both patients as well as the cost of healthcare. The necessary innovations and targeted medicines will come of age in research labs and then make their way into standard medical practice.

Take Next Generation Sequencing (NGS) as an example. Tecan has worked from the earliest stages with the innovators in the field. They needed to generate vast amounts of data to prove the technology's value, to scale processes and to make them robust. As clinicians see the value of sequencing in prediction, early detection and preventative strategies, they in turn need to validate applications. This will require the consistent high quality and standardization brought about by automation, reagent kits and turnkey solutions that are compliant to regulations. Today, NGS is starting to be integrated into many routine diagnostic procedures, and its clinical value is well accepted by the laboratory, the clinic as well as the patient. Surveillance of the SARS-CoV-2 virus mutations rely on NGS technologies, as do several newer approaches to the individual diagnosis of cancer, metabolic disorders and rare disorders.

Tecan was and still is involved in every stage of the NGS success story from the research lab to the clinic.

We clearly see our role in bringing innovation into healthcare and thereby broadening its impact. Hospitals strive to meet the increasing test volumes while maintaining the productivity and precision expected in all countries. Tecan is prepared to address this growing need.

We expanded our scope by acquiring Paramit. Paramit is a leading OEM developer and manufacturer of medical devices and life sciences instruments. The company delivers for example critical modules and systems to partners which drive innovation in robotic surgery, point-of-care and personal testing devices, as well as systems for home hemodialysis and patient monitoring. Paramit is key to our ambition to scale healthcare innovation globally, well beyond the laboratory.

As the scaling of healthcare progresses, new innovations will inevitably arise. This will go hand in hand with the trend towards systems that are simpler to use, and that are even more intuitive, to eliminate human error.

More innovation, yet more simplicity. More volume, yet better quality. This will require Tecan's and Paramit's combined expertise in lab automation, life science instruments and medical devices. With Paramit now a part of Tecan, we continue to empower our partners and customers with scalability and productivity, reproducibility and standardization, precision, robustness at scale and regulatory compliance.

With this expanded vision, we have revised our purpose statement: At Tecan we are driven to improve people's lives and health. We do this by empowering our customers to scale healthcare innovation globally from life science to the clinic.

Working early on in the innovation process in close collaboration with our customers, enables us to deliver leading products services and solutions globally, that help make lab processes and medical procedures scalable, trusted, precise, compliant, and the data and outcomes ever more reproducible.

Tecan is thereby prepared to empower this future.


Sincerely,

Dr. Achim von Leoprechting
Chief Executive Officer

SARS-CoV-2 and infectious diseases

Preparedness and scalability

Beyond SARS-CoV-2

Taking the guesswork out of diagnostics

Closer to the clinic

Researching diseases for clinically relevant solutions

Bridging the gap

A toolbox of clinically relevant solutions to generate results

Precision beyond the lab

Expanding our horizons into medical devices

The future is personal

Improving people's lives and health
ANNUAL REPORT 2021

SARS-CoV-2 and infectious deseases

The COVID-19 pandemic has brought into sharp focus the challenge faced by research labs and clinical testing facilities when they need to scale up their innovations and workflows, since effective scale up for testing and diagnosis was needed within an incredibly short timeframe.

However, the timing also presented the industry with an opportunity: this was the first pandemic where automation was able to play a critical role, from antigen and PCR testing to viral sequencing and mRNA vaccine development. Tecan was called upon at an early stage of the pandemic for precisely this reason, providing a powerful response at a time of global need.

The scale of the pandemic put an immediate strain on laboratories conducting PCR testing, the gold standard for SARS-CoV-2 testing, as well as on labs screening drug candidates for treatments and developing vaccines. Even small labs and organizations had to rapidly shift focus and expand their output at an unprecedented rate, from R&D and manufacturing to clinical diagnostics.

Key to Tecan’s rapid response was its ability to supply readily available, modular end-to-end solutions, many of which Tecan and its partners had developed and approved for nucleic acid purification and Next Generation Sequencing (NGS) sample prep, including adaptations of its Fluent® and Freedom EVO® instruments.

Tecan was intrinsic to several key activities to scale up COVID-19 responsiveness. First, Tecan Partnering supplied its existing in vitro diagnostics OEM partner companies with components, complete systems and disposable pipette tips to scale up testing. Then, as demand further increased, significantly higher testing throughput was achieved in a matter of months through a new partnership with Thermo Fisher Scientific to develop the Amplitude System, a completely new walk-away PCR solution, capable of running up to 8,000 tests a day. Ultimately, new high-capacity facilities were urgently needed to address the scale of the pandemic. Under normal circumstances, these would be developed from the ground up. Fortunately, through its LabwerxTM program, Tecan expedited design and implementation ‘beyond the ordinary’, and delivered fully customized solutions that dramatically improved time-to-market and scalability.

The effectiveness of the Tecan Labwerx approach is exemplified by work with the Hubrecht Institute in Utrecht, Netherlands. Researchers recognized that the gold standard PCR test worked well to identify SARS-CoV-2 positive patients, but that there were challenges with logistics, and a need for automation. What started with a fortuitous introduction to an automation expert from Genmab grew to involve additional partners. The successful collaboration led to significantly increased SARS-CoV-2 testing capacity in the Netherlands through the development of the STRIP-1 robot.1

Tecan Labwerx helped the Hubrecht Institute incorporate its Fluent system into the viral sample prep workflow. The whole RNA extraction process can now be carried out in 384-well format, increasing speed, and reducing the quantity of reagents required. The Dutch government has since ordered five more systems, with each platform capable of processing more than 10,000 samples in 24 hours.1

Tecan continues to play a substantial role in the COVID-19 pandemic response, rapidly deploying workflows to automate nucleic acid extraction and purification as well as sample preparation and assay setup, especially for NGS and PCR-based techniques. The result of this modular approach has been the successful scale-up of viral characterization, to a level where many thousands of samples can now be processed by a single lab.2 How Tecan extrapolates the learnings and experience gained from the pandemic response will be the next step.

1 www.tecan.com/tecan-journal/innovation-in-covid-19-testing-by-dutch-public-private-partnership
2 www.tecan.com/blog/pandemic-preparedness-scaling-up-for-the-healthcare-industry


Taking the guesswork out of diagnostics.

COVID-19 provides a unique opportunity to extend the progress made during the global pandemic to some of the world’s biggest diagnostic challenges in infectious diseases and beyond.

Tecan’s pandemic response demonstrated to the world that we can move quickly in collaboration with our partners to supply essential building blocks of instruments, deliver complete testing equipment as well as create custom-made instrument systems, at previously unfeasible scales. This is also true for needs beyond the COVID-19 response. Tecan is working with innovators of completely new approaches across a range of infectious diseases. Take, for example, the San Francisco Bay area-based company IDbyDNA Inc, where an automated test has been developed that can give detailed diagnostic reports on hundreds of pathogens associated with respiratory and urinary tract infections.1

The IDbyDNA test is based on metagenomics, the study of a collection of genetic material from a mixed community of organisms.2 Metagenomics is a rapidly emerging and promising method for disease diagnosis, but the need for manual processing extends turnaround time, thereby limiting clinical adoption. Dr John Rossen and the IDbyDNA team have successfully automated a metagenomics approach to speed the transition of their assays from research to routine testing in clinics.

Current clinical metagenomics applications use shotgun sequencing, which is a broad, unbiased, and culture-independent technique to jointly analyze pathogen and host responses. It provides insights into complex co-infections, helps identify previously missed pathogens, and can even be used to predict phenotypes that worsen disease outcomes. However, shotgun sequencing does not allow detailed analysis of several key aspects, such as antimicrobial resistance markers, and is expensive compared to targeted approaches.

IDbyDNA developed an innovative precision metagenomics approach to overcome these limitations. Their sequencing strategy, combined with advanced AI, is already being used for the diagnosis of respiratory and urinary tract infections, and to identify antimicrobial resistance markers. The company has partnered with Tecan to automate its workflow for clinical sample prep, taking advantage of Tecan Partnering’s OEM outsourcing program.

For patients with an unknown respiratory complaint, we typically perform a single molecular or bacterial culture test for a suspected target organism, leading to low diagnostic success rates, with no causative pathogen detected in 60 percent of pneumonia cases.

IDbyDNA has created an assay that can identify over 270 pathogens and around 1,200 different antimicrobial resistance alleles in a single assay. As a consequence, the same assay can be used for a patient presenting with COPD symptoms as well as for a patient with suspected tuberculosis, for example. IDbyDNA have now adapted this approach to develop a single workflow that could be used for almost every disease area, including respiratory infections, genito-urinary infections, sepsis and many more.

IDbyDNA has already automated its data analysis and reporting, and is now automating all its laboratory workflows. This will include the library preparation and enrichment process, to make precision metagenomics a realistic alternative to real-time PCR for disease diagnostics in a clinical scenario. The next step is the move into the clinic itself.

1 www.tecan.com/tecan-journal/taking-the-guesswork-out-of-diagnostics
2 Afshinnekoo, E., Chou, C., Alexander, N., Ahsanuddin, S., Schuetz, A. N., & Mason, C. E. (2017). Precision Metagenomics: Rapid Metagenomic Analyses for Infectious Disease Diagnostics and Public Health Surveillance. Journal of biomolecular techniques: JBT, 28(1), 40–45. doi.org/10.7171/jbt.17-2801-007


Researching diseases for clinically relevant solutions

While COVID-19 still dominates the current healthcare debate, research into early detection and treatment of non-communicable diseases remains paramount. The experience and knowledge gained in the R&D lab are essential for the conversion of relevant solutions to the clinical market and into hospitals. Tecan plays a central role in this transition, supporting its customers as their partner of choice.

Take cancer, Alzheimer’s or Huntington’s disease – diseases where early detection is crucial. Imagine if we could identify these diseases long before symptoms manifest. It would then be possible to initiate preventative treatments with targeted therapies, and thereby further realize the promise of precision medicine.

Considering the immense healthcare burden of diabetes, cancer, and heart disease in our steadily ageing population, the urgency for scalable, global healthcare innovation from lab research to the clinic becomes evident. Innovative technologies to address healthcare challenges come of age in research labs and then make their way into standard medical practice.

Tecan is advancing in vitro diagnostics (IVD) and medical technology by enabling transitions for technologies such as Next Generation Sequencing (NGS) and many others. By enabling the automation of tests, making them feasible at a scale for commercial labs, Tecan makes it possible for these tests to realize their potential in the clinic. In this way, Tecan is building bridges and acting as a chaperone towards adoption of these tests into routine practice.

Tecan has fulfilled this mission in numerous successful collaborations. For example, Tecan is enabling live cell imaging to develop a novel 3-D technology to reconstruct physiologically relevant and organ-specific human microenvironments for drug discovery and development,1 together with the US-based company zPREDICTATM. High throughput cell imaging and real-time cytometry of 3-D cell cultures can give daily resolution of cellular behavior and modulations of various immune cell populations to evaluate the efficacy of anticancer drugs.

Tecan’s collaboration with US-based Ambry Genetics is in NGS. Ambry Genetics is an industry leader in genetic testing, translating scientific research into clinically actionable test results based on a deep understanding of the human genome and the biology of genetic diseases. The company operates a CLIA-licensed genetic testing lab, processing clinical samples with NGS, followed by Sanger sequencing to verify clinically relevant results. Ambry Genetics initiated a major project to automate their protocols to reduce test turnaround time. After considering a broad range of factors, including flexibility, third-party device integration, scalability, and price, Ambry selected the Tecan Fluent® to build a super lab to automate NGS of clinical samples and scale-up in a regulated environment.2

Tecan is drawing on decades of relevant experience and capabilities in this transition to the clinic that started in life science research. All our expertise in technologies, hardware and software platforms, and application know-how are brought into focus. For innovative solutions to evolve from research labs to the clinic, the robustness of these sophisticated methods is key. Tests must be easy to implement at higher volumes, with better quality, and more simplicity. This is precisely where the challenge lies, and the next step is to be taken.

1 www.tecan.com/tecan-journal/dont-miss-a-beat-with-live-cell-imaging
2 www.tecan.com/blog/ambry-genetics-builds-a-superlab-to-automate-ngs-of-clinical-samples


A toolbox of clinically relevant solutions to generate results

A toolbox of clinically relevant solutions to generate results How do you successfully advance a test from the bench of a research lab to the clinic? How do you transform innovative analytical concepts into clinically relevant solutions fit for the hospital? These questions are central to scaling healthcare innovation globally.

And that is exactly what Tecan has set out to do: to make these transitions successful. It takes both research lab and clinical expertise to develop a toolbox of relevant solutions that delivers results. In breakthrough advances, this involves bringing together different technologies. In addition, a profound knowledge and experience in developing systems for in vitro diagnostic (IVD) and medical applications regulated by the FDA and other bodies is essential. Tecan Partnering enables IVD companies to implement Tecan’s technologies and ‘IVD-ready’ platforms to develop complete solutions, including kits and reagents, making them ready for routine use in hospitals. How does Tecan gain this valuable experience and know-how to benefit IVD companies and other customers?

It originates from our exposure to new applications, and the system adaptations we make to power them. For example, in computational biomedicine, a discipline at the forefront of epigenetics, Professor Christopher E. Mason at Weill Cornell Medical College, NY, has developed new technologies to catalog genetic and epigenetic changes caused by everything from cancers to novel viruses. “We were quickly able to use Tecan’s DreamPrepTM NAP workstation to set up and run a high-throughput platform to extract and process genetic material obtained from either clinical samples or the environment. It is a real workhorse and very reliable, with the pre-programmed protocols working well.

Tecan enabled us to make a broad health impact and achieve high throughput, which directly equates to scalability,” concluded Professor Mason.1 The value of this toolbox approach was also evident at Leiden University Medical Center in the Netherlands, which has integrated a standard Tecan Next Generation Sequencing (NGS) workstation into its molecular diagnostic testing and clinical research workflows.2 The preconfigured solution has enabled the Center to quickly commission the platform for routine testing while having the flexibility to develop new protocols and conduct research studies.

In hospital labs, there is a clear need for easy-to-use systems and ready-to-use diagnostic kits, especially when it comes to sophisticated technologies like NGS. When hospital and lab staff can use such advanced technologies without resource-intensive training, the barrier to widespread adoption is massively reduced. By partnering with Tecan, IVD companies gain access to the company’s application and regulatory experience as well as proven technologies that make it possible for their technology to take the key step of transition into the clinic remarkably fast and with the highest confidence.

Tecan’s recent acquisition of Paramit is yet another step towards fulfilling these ambitions in healthcare innovation. It extends Tecan’s technology reach well beyond the lab, building a bridge to precision healthcare. The future of healthcare innovation just got a little bit closer.

1 www.tecan.com/tecan-journal/computational-biomedicine-at-the-forefront-of-epigenomics
2 www.tecan.com/tecan-journal/2015/11/17/off-the-shelf-ngs-library-prep-for-ion-torrent-sequencing/


Expanding our horizons into medical devices

In 2021, Tecan’s ambition to scale healthcare innovation globally culminated in the acquisition of Paramit, a leading OEM developer and manufacturer of medical devices and life sciences instruments.1

Paramit is key to Tecan’s ambition of providing healthcare solutions globally. It brings well-established and unique expertise of precision production engineering, mechanical assembly, and electronics manufacturing to produce FDA-approved medical devices. The company’s portfolio includes critical modules and systems for surgical robotics, point-of-care and personal testing devices, as well as systems for home hemodialysis and patient monitoring.2

Tecan’s acquisition of Paramit enhances Paramit’s capabilities and market leadership in life sciences and in vitro diagnostics (IVD), accelerates Tecan’s entry into medical devices, and expands the combined businesses’ total addressable market across the globe.

One example is Paramit’s collaboration with Intuitive Surgical, Inc. (Intuitive). Intuitive, a leading pioneer of robotic-assisted surgery, brings more than two decades of leadership in minimally invasive surgery and medical diagnostic solutions. Its portfolio includes the hallmark da Vinci surgical system and the Ion endoluminal system. The company strives to make surgery more effective, less invasive and easier on surgeons, patients and their families.

Paramit has served as a long-term business collaborator with Intuitive, including work on several generations of core products that are used in the manufacture of Intuitive’s surgical instruments, robotics, and training suites. Paramit’s deep collaboration with Intuitive is testament to its approach toward product quality, manufacturing scale-up, speed and control, which are all necessary capabilities for advancing the development and manufacturing of FDA-cleared medical devices.

One of Paramit’s key differentiators is vPoke® — a patented, computer-directed assembly technology that generates a rich device history record, providing component traceability, while reducing the potential for errors (‘zero-defect manufacturing’). The name ‘vPoke’ is derived from the Japanese term ‘poka-yoke’, which loosely translates as ‘mistake-proofing’. Poka-yoke uses techniques such as locking keys, fixtures, and robotics, to help avoid human error.3

With Paramit now a part of Tecan, our expertise in lab automation, life science instruments and medical devices will continue to empower partners and customers alike with scalability and productivity, reproducibility and standardization, precision, robustness at scale, and regulatory compliance.

Together, we have a common goal: to facilitate early detection, disease prevention and precision therapies, with the long-term prospect of alleviating the burden on both patients and the cost of healthcare. The acquisition creates a combined global platform with world-class design, development and manufacturing capabilities and scale that will be able to provide unparalleled support to customers in some of the fastest growing segments in healthcare.

1 www.paramit.com/2021/08/02/paramit-corporation-completes-sale-to-the-tecan-group/
2 www.paramit.com/portfolio/
3 www.paramit.com/vpoke-mechanical-assembly/


Improving people’s lives and health

Preventative therapies based on insight, prediction, and precision: ongoing healthcare developments and insights are shaping the future of medicine. Ambitions are significant, not least because the challenges of global healthcare demand immense determination.

Innovation will be central. Players that are prepared to move innovation from the research lab to the hospital will be essential to the process. Innovation, per definition, is synonymous with risk and uncertainty; healthcare requires reliability you can trust. Tecan assures the highest standards through our decades of experience and our steadfast compliance to global regulatory requirements.

Spurred by a global pandemic, our eyes have been opened to the world’s potential to transform an idea into a solution. We can benefit from the momentum and improve healthcare through the adoption of innovative approaches across a range of disease areas. The many opportunities include disease prevention through the monitoring of risk biomarkers; early detection through noninvasive testing; broader testing procedures; precision treatments for every patient profile; and health and wellness empowerment from data on traits and ancestry provided by consumer genetics.

To address global healthcare needs, the world needs to think and act in scales never before conceived. It will need to extend science and technology from the minds of a few experts into the fingertips of many people from diverse disciplines. This is the route to provide solid diagnostic results to take confident decisions, made accessible to every healthcare provider.

The future is personal. And with the potential to imagine, it is in sight.

With the ability to engineer, it becomes a solution. Empowered by scale, it becomes reality.

Tecan is prepared to empower the future of medicine – scaling healthcare innovation globally.

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