The landscape of point-of-need molecular diagnostics has changed a lot over the course of the past decade. It has switched from being an exception to being the norm. Molecular diagnostics detect the presence or absence of a pathogen in a sample by amplifying and detecting its genetic signature in the form of DNA or RNA instead of relying on antibodies or antigens as in immunoassays, which are usually less reliable. There is potential for use not only in human or veterinary diagnostics, but also in areas like agriculture, food safety and water monitoring. However, the challenge was and is still automating and miniaturizing complex laboratory processes on-chip, in a reliable manner, and at a low cost. In addition, the value of such tests lies in getting rapid results, in minutes instead of hours, which is also a challenge.
In its recent report Point-of-Need 2020 – Including PCR-Based Testing, Yole Développement detailed the landscape of molecular tests for rapid diagnostics at the point-of-need. Over the past decade, some companies achieved development of rapid molecular tests detecting a couple pathogens per test in less than half an hour, like Mesa Biotech, IQuum, which is now part of Roche, and Alere, now part of Abbott. Other companies like BioFire, now part of bioMérieux, and Stat-Dx, now part of Qiagen, developed panels that detect a higher number of pathogens in a single test, but also take more time. There are no platforms enabling highly multiplexed molecular diagnostics in a time window corresponding to the duration of a classic medical appointment – yet. But developments are ongoing, as in Poland, where Scope Fluidics has developed its PCR|ONE platform. Sébastien Clerc, Technology and Market Analyst, Microfluidics at Yole Developpement, had the opportunity to interview Piotr Garstecki, CEO & Founder at Scope Fluidics. Piotr shared the latest information about the company’s developments, along with his view of the molecular diagnostics landscape evolution. Below is a summary of the discussion.
Sébastien Clerc (SC): Could you please introduce yourself and your company?
Piotr Garstecki (PG): Scope Fluidics develops medical diagnostic systems in response to global challenges in healthcare. We designed Scope Fluidics to use know-how in microfluidics and the interdisciplinary melting pot of the dreams of our team members, to answer the most pressing needs in medical diagnostics. I am a physicist by training, who happened to get academic degrees in chemistry departments. The adventure with microfluidics started with George Whitesides at Harvard, and continued at the Institute of Physical Chemistry, Polish Academy of Sciences in Warsaw. This led to the creation of Scope Fluidics in 2010 together with Marcin Izydorzak – a chemist with over 10 years of experience in managing R&D in pharma. We started with contract work, built our team and infrastructure, and since 2015 we have developed our own products. In 2017 Scope Fluidics went public – it is now listed on the NewConnect market on the Warsaw Stock Exchange.
Currently, Scope Fluidics runs two projects, each contained in an SPV: Curiosity Diagnostics that develops PCR|ONE – a POCT molecular Dx system combining record speed, ease of use and multiplexing power with low cost of tests, and Bacteromic, that develops an inexpensive system of high-throughput culture-based antibiotic susceptibility testing – offering the fastest access to information guiding precision antibiotic therapies.
SC: What is the PCR|ONE platform and what is the technology behind?
PG: PCR|ONE is a POCT system – a complete solution for immediate detection of a wide range of pathogens and genetic targets at the point of care. The system accepts disposable cartridges that are loaded with clinical samples and automatically processed for detailed diagnosis within 15 minutes.
We believe that two main features define the value of a POCT test – accessibility and actionability. Access to testing depends on speed – because in many situations you cannot wait for the answer longer than 15 minutes, on ease of use, so that anyone can run the test, and price. Actionability depends critically on the completeness of the information package – so that the result of the test forms a solid base for a clinical or infection control decision. We designed PCR|ONE to deliver actionable information in the most accessible format – inexpensive, fast, and easy to use.
Delivering detection of up to 20 genetic targets in a 15-minute sample-in-answer-out test requires technology. We use our own, custom developed technologies for rapid cycling, to deliver 40 cycles of real-time PCRin seven minutes, and microfluidic solutions for multiplexing, and flexibility in sample preparation, isolation, and purification protocols. PCR|ONE conducts each PCR in a separate micro-well and uses triplicates of each reaction for maximum robustness and accuracy. The analyzer and cartridge offer four types of lysis, filtering, and diverse liquid-handling protocols for lysis, isolation, and purification of genetic material.
SC: Why is this platform a game-changer for the point-of-care molecular diagnostics industry? How is it different from existing technologies and what is its added value?
PG: The essence of the POCT revolution is to make important information accessible at the point of need. Accessibility means that the test can be done, and it can only be done if it is fast enough for the given use scenario, if you can afford to buy it, and if it does not require a specialist to execute. The other side of the coin is importance of information – and this is gauged by the decisions that can be taken with the information in hand. Imagine that you detected the presence of pathogen, and the doctor asks – “OK, but is this the hypervirulent strain – because this would really change what I will recommend?”, or the doctor sees a negative result for Covid, and asks “Could this be flu or RSV, or do we need to isolate and wait?” In molecular diagnostics, the POCT revolution translates into highly multiplexed tests that are easy to use, fast and possibly inexpensive. This is how we designed PCR|ONE.
The way we have gotten here was not obvious – and as it often is the case in R&D and discovery, some was down to chance. We started the project with the idea to build a fast, POCT digital PCR system, and hence we went for physical multiplexing from the very onset of the development. Along the way we have seen clearly that the world needs highly multiplexed POCT molecular tests more than POCT digital quantitative tests, and we adapted to this need. Perhaps this is the reason behind the clear differentiation from the competitive systems.
SC: What is PCR|ONE’s development status? What was the most challenging aspect of the development? Do you have a timeline in mind for commercialization?
PG: We had just readied the system for formal clinical validation of the MRSA/MSSA/PVL detection and characterization panel when the Covid-19 pandemic broke out. We are now developing the Covid-19 detection test, and preparing for clinical validation of the MRSA and Covid-19 tests as soon as possible, with the intent to place the system on the EU market this year. If possible, we will also enter the US market through EUA, if not, we will start the standard regulatory procedure for the US.
SC: What kind of panels are you targeting? What’s next on your roadmap?
PG: We have already developed the fastest and most comprehensive MRSA detection panel, and are now working on the Covid-19 detection test. We will then move to build the portfolio for syndromic respiratory infection, gastrointestinal infection, sexually transmitted diseases, gram-negative antibiotic resistance panels. We are also considering development of a public-health monitoring panel, that could be used at airports, for example, to detect the pandemic threats listed on the WHO’s watchlist.
SC: What’s your business model and which type of customers will your technology serve? What’s the use case?
PG: The market for POCT molecular diagnostics is exciting not only because it’s expanding so dynamically now, but also because it is becoming so diverse. As diagnostics become more accessible, new use scenarios become viable market options. Thus, besides the traditional placement in hospital labs, in ICU, the market expands towards GP offices, admission wards, but also pharmacies, companies and public places. The pandemic has made it very clear how valuable testing is at the point of need. Think of the caretakers in the retirement homes and how valuable it is to be able to test every day, conveniently and swiftly, without adding the cost of waiting. Diagnostic tests are being introduced to airports as we speak. Clearly the market is growing and broadening. We believe that with the combination of ease of use, 15-minute turnaround time and 20-plex capacity, PCR|ONE offers a very flexible platform for development of highly specialized panels for a versatile range of specific use scenarios.
SC: What’s your manufacturing strategy, now and in the future? Can you explain why you made this choice?
PG: We developed the pilot manufacturing lines in-house, as this strategy optimized time and cost of development. We are now looking into expanding production capacity. Being a relatively small technology and intellectual property development business means we are fast and agile in the initial concept development, bringing it to a commercially ready stage, while now we work with partners able to bring the marginal production costs down by scaling-up to mass production.
SC: Almost all the past decade’s innovators in point-of-care molecular diagnostics got acquired by large players: BioFire, IQuum, Stat-Dx, GenePOC, and even Cepheid are now part of larger corporations. Is this a mandatory step for innovators to get wide market access?
PG: It has been clear for us from our inception, we want to focus on developing the technology and IP, to demonstrate manufacturability, and to bring the system through the regulatory process. We focus on developing the best technology, which should be leveraged on the market with the use of appropriate sales and marketing channels. PCR|ONE answers the market need globally and we are open to partnerships that will take best advantage of the functionality of the system.
SC: Do you have an advice for start-up companies in the field of point-of-care testing?
PG: Ha! It’s difficult because you need to combine fire and ice. You need to be bold and stubborn in your vision, because this is critical for generating a break-through. At the same time, you need to listen very carefully to the users, and if evidence is convincing, adopt, to meet the specific need. This is critical to developing things actually useful. How to negotiate this slalom? At least remember to have both in your quarter-by-quarter plans.
 DNA: Deoxyribonucleic acid
 RNA: Ribonucleic acid
 SPV: Special Purpose Vehicle
 POCT: Point-of-Care Testing
 Dx: Diagnostics
 PCR: Polymerase Chain Reaction
 RSV:Respiratory syncytial virus
 MRSA: Methicillin-Resistant Staphylococcus Aureus
 MSSA: Methicillin-Sensitive Staphylococcus Aureus
 PVL: Panton Valentine Leukocidin
 EUA: Emergency Use Authorization
Professor Piotr Garstecki is a full Professor at the Institute of Physical Chemistry, Polish Academy of Sciences, in Warsaw, Poland. He was a postdoctoral fellow at Professor George M. Whitesides Group at Harvard University. He currently leads the Research Group of Microfluidics and Complex Fluids at the Institute of Physical Chemistry in Warsaw. The group conducts research on fundamental aspects of the physics of soft matter systems and develops microfluidic tools for chemistry and biology. He co-authored almost 150 scientific publications (in the renowned scientific journals, such as: Nature, Nature Communications, Angewandte Chemie, Nature Physics) and multiple patent applications. He also co-founded three spin-off companies: Scope Fluidics, Curiosity Diagnostics and Bacteromic, working on the use of microfluidic technologies in medical diagnostics.
Sébastien Clerc is a Technology & Market Analyst in Microfluidics, Sensing & Actuating at Yole Développement (Yole).
As part of the Photonics & Sensing team, Sébastien has authored a collection of market and technology reports dedicated to microfluidics and other micro-devices for both market segments: medical (including diagnostics, pharmaceutical, biotechnology, drug delivery, medical devices) and industrial (including environment, agro-food).
At the same time, he is involved in custom projects such as strategic marketing, technology scouting and technology evaluation to help academic and industrial players in their innovation processes. Thanks to his technology & market expertise, Sébastien has spoken in more than 20 industry conferences worldwide over the last 4 years.
Sébastien Clerc graduated from Grenoble Institute of Technology (Grenoble INP – Grenoble, France) with a Master’s degree in Biomedical Technologies. He then completed his academic studies with a Master’s degree in Innovation and Technology Management in the same institute.
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