Last week of March Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects – hosted Prof. Carl Wittwer, American scientist who developed in the 1990s the first PCR (polymerase chain reaction) system which was capable of carrying out the reaction in less than an hour. It was the first system for determining the amount of genetic material. The founder of Biofire Diagnostics also developed the FilmArray system for medical diagnostics, which was acquired in 2014 by Bio Merieux for USD 450 million. Professor Wittwer spent three days at Scope Fluidics and consulted the team on the technical issues related to the development of the PCR|ONE system.
The polymerase chain reaction (PCR) is the backbone of all genetic analyses. It was developed in the 1980s by Kary Mullis, but it was Prof. Carl Wittwer who made it possible for this method to be used in rapid diagnostics. Professor Wittwer created the first apparatus that allowed the PCR reaction to be carried out in less than an hour. He then created the first system that allowed the progress of the PCR reaction to be tracked over time and, on this basis, the determination of the amount of genetic material in the sample as well. This apparatus was later taken over by the Roche concern. Professor Wittwer is also a pioneer of point-of-care systems which, in addition to the PCR analysis itself, prepare the sample in a fully automatic manner, in order to determine the presence of specific genes directly in the sample taken from the patient. Wittwer’s FilmArray system offers the detection of multiple genes in about an hour and was acquired in 2014, together with BioFire Diagnostics, by BioMerieux for almost half a billion dollars.
– We are witnessing a revolution in medical diagnostics. Point-of-care diagnostics is growing at a rate of 10% year on year, and diagnosis of infectious diseases is the largest segment of diagnostics in general. Prof. Carl Wittwer is for this market what Steve Woźniak is for the computer market. Prof. Wittwer has been involved in electronics since childhood, he is a physician and biochemist, and in the garage with his colleagues he created the first convenient and rapid system for conducting PCR reactions. He introduced a number of key technical solutions in this area. His interest in the emerging PCR|ONE system in the Scope Fluidics group is for us a confirmation of its value for the health care market, says Prof. Piotr Garstecki, co-founder, key shareholder and CEO of Scope Fluidics.
The PCR|ONE system is the first in the world to introduce point-of-care panels to the market, offering a PCR response in just a few minutes, with a total tagging time of up to 20 genes, even less than a quarter of an hour.
PCR|ONE is a unique solution for monitoring hospital-acquired infections. It is a very fast technology that carries out extreme PCR reaction, real-time amplification and melting analysis to detect dangerous bacterial strains much faster than any other available technology. Its great advantage is also the very low cost of testing, explains Prof. Carl Wittwer.
Professor Wittwer spent three days consulting our team on the development of the PCR|ONE system and its introduction to the health care market. He shared his knowledge and comments, both in technical and market aspects as well as in the organization of the team.
The PCR|ONE diagnostic system created by Scope Fluidics focuses on the most important global threats to the health care system – two very well identified pathogens that cause HAIs. I am impressed by the dynamics of Scope Fluidics and the team that intends to introduce a cost-effective molecular diagnostics system to reduce hospital-acquired infections, says Prof. Carl Wittwer.
Professor Wittwer is also an academic. To this day he conducts research at the University of Utah. He was the first in the world to demonstrate that a PCR reaction could be carried out in record time – even in just a few minutes. His scientific publications were one of the most important inspirations for creating the PCR|ONE system.
It is a great experience for me to demonstrate to Professor Wittwer the operation of the PCR|ONE system and see his interest in our technical solutions. I can well remember how a few years ago his papers about the ‚minutes-long’ PCR inspired us to create these solutions, says Dr. Kamil Gewartowski, PCR|ONE project manager at Curiosity Diagnostics.
Professor Wittwer is one of the most important authorities in the field of molecular diagnostics technology, he continues to actively conduct research, lecture and comment on the development of technology in this field.
There are only a handful of scientists in the world who know PCR technology so well. This is a person who leaves no questions unanswered in this area. Professor Wittwer’s support is a great honor for us and will certainly facilitate the introduction of the PCR|ONE system on the market, says Prof. Piotr Garstecki, CEO of Scope Fluidics.
The PCR|ONE system carries out a fully automatic analysis of the genetic material of bacterial and viral pathogens. The product is unrivalled in terms of rapidness and complexity of the analysis – it is able to recognize up to several dozen pathogens within several minutes of sampling. Thanks to that, the device can be used in the point-of-care format, i.e. directly at the emergency room. This will allow hospitals to significantly reduce typical HAIs and thus reduce patient treatment costs.
The PCR|ONE system is to be admitted to commercial trading in the first half of 2020. The EU certification of the device is to be completed at the same time. American advisory company Clarfield International participates in acquisition of the buyer of Scope Fluidics’ system. Commercialization of the project will consist in the sale of the entire company with a complete package of intellectual property, product development and registration of the device. According to the company’s articles of association, Scope Fluidics will pay out at least half of the profit generated from the sale of the project as dividends to the shareholders.
The PCR|ONE system places itself on the dynamically growing market of molecular diagnostics. According to Markets and Markets, the global value of this market in 2021 will amount to 10.1 billion dollars, which with the current value of 6.5 billion dollars means an average annual growth rate of over 9 percent.
About Professor Carl Wittwer:
Carl Wittwer is a pioneer in the PCR (polymerase chain reaction) technology, which is now the golden standard in medical diagnostics. He is the main inventor of the LightCycler device, more than 10,000 pieces of which have been sold worldwide by Roche. In 2003 the portable version of the LightCycler, the R.A.P.I.D. was selected by the US government as the real-time PCR platform for military defense against biological weapons. In 1990, Wittwer founded BioFire Diagnostics, whose FilmArray diagnostic system can identify more than 20 respiratory pathogens per hour. BioFire Diagnostics was acquired by BioMerieux in 2014 for USD 450 million
Carl Wittwer holds 34 U.S. patents and their foreign equivalents. He has published more than 200 scientific papers and chapters of books on molecular diagnostics. He has received numerous awards, including the Utah Governor’s Medal for Science and Technology (2003), the AACC Award for Outstanding Contributions To Clinical Chemistry (2004), the IFCC-Abott Award for Significant Contributions To Molecular Diagnostics (2005), the AMP Award for Excellence in Molecular Diagnostics (2008) and the University of Utah Innovation Award (2011). Wittwer, PhD is a professor of pathology at the University of Utah School of Medicine and a medical director at the Associated Regional and University Pathologists in Salt Lake City.