In an industry of giant molecular diagnostics companies lies a need for agile SMEs like PSS to achieve results in a short time span. PSS has been able to deliver where established companies have “lacked the inspiration to produce compact and easy-to-use products,” as Hideji Tajima, President of PSS, explains. Innovation is key to PSS, as seen with their magnetic filtration technology (Magtration®), ELITe BeGenius product for ELITech, and moves towards reducing the automated PCR test results to less than an hour, all of which Mr. Tajima goes into more detail in this interview.
Japan is a leader in developing drugs and medical devices that are used worldwide. What contributions has Precision System Science (PSS) made to the medical field?
I learned the business from a domestic perspective, but I have a close relationship with an international partner who worked in Abbott before and since then, I have established connections with Roche and Thermo Fisher. As an SME, we have learned that big companies lack the inspiration to produce compact and easy-to-use products. PSS has received praise from larger companies for providing compact technology quickly and efficiently with highly accurate and precise diagnostic results. We will continue looking into what we can do as an SME and doing what major companies don’t have the inclination to do themselves.
We have developed automated technologies that allow sample-to-result: nucleic acid extraction (DNA or RNA etc) to amplification and detection, and these can be used to conduct PCR testing quickly – in just two hours. The equipment is small yet high-tech and we believe it is one of a kind. Our design concept is to develop devices that are small, compact, efficient, easy to use, and highly accurate and precise diagnostic results, therefore with features that large companies usually don’t provide.
Magnetic filtration technology, or Magtration, is the core of our business. It uses magnetic beads and the system we have developed, and we realised that Magtration technology is very efficient in terms of sample preparation (nucleic acid extraction) of open systems in the field of molecular diagnostic and that is how the technology was developed. This is the very first automated sample preparation system that succeeded and thanks to this, we have received OEM orders from Roche and QIAGEN and have produced about 40,000 units so far.
Healthcare systems in many countries have been severely affected by the COVID-19 pandemic. As you mentioned, you have developed a fully automated PCR testing system that reduces testing time from six to two hours and removes the possibility of human error. How can such devices help mitigate the impact of future epidemics or pandemics, especially in countries with weak healthcare systems, such as developing and low-income nations?
PCR testing offers a high possibility of detection right after infection compared to protein-based antigen testing. If middle and low-income countries were to introduce a system to detect future infectious diseases, then PCR testing would be advantageous, and we would promote its adoption. About twenty years ago, we collaborated with the Japanese Red Cross Society to reduce serum hepatitis incidence after transfusions, and in addition to working with Roche, we were involved in preventing not only serum hepatitis, but also the spread of HIV and other diseases transmitted by blood, including through transfusions, by developing a device of sample preparation that could confirm contaminated blood combining a sample pooling method for multiple detection. Thanks to that, we have been able to significantly decrease the spread of hepatitis and HIV transmissible by blood.
In addition to our Magtration® technology, we are developing a print-made cartridge. The systems used by major companies are becoming very complex and by providing this cartridge pre-filled with reagent – and allowing any country in the world to use it – new contaminants can be detected. We have also developed a “soak stick kit”: a saliva sample is taken, and the vial doesn’t need to be filled with reagent by the testing machinery if used in combination with the cartridge. The saliva kit is combined with an inactive virus infection like COVID-19 solution, meaning the person conducting the test won’t be infected.
8 years ago, we established a partnership with French company ELITech, who wanted to sell their PCR reagent with their machinery. The OEM product is sold as ELITe InGenius, but now we are developing a version called BeGenius which we have announced publicly. We have high expectations for providing our products to ELITech, in addition to evolving with them and gaining a stronger market presence.
At the same time, there are many challenges. One of them is that it takes two hours for us to get the fully automated results of the PCR test with highly accurate and precise diagnostic results, however we want to reduce this to less than an hour with the same quality of diagnostic results. To reach this goal, we will increase the speed of hardware movement, while also upgrading the software to be more efficient. We are doing our best to evolve this as a business, as well as contribute to society, by providing an automated PCR testing device that takes less time, and which would be particularly convenient for locations such as airports. It is also very compact, so placing it in these locations wouldn’t be difficult.
The machine itself scans barcodes placed on the samples, however, to ensure that there are no mistakes, handwritten labels that the machine can recognise are also used. Since the process is automated, the samples aren’t at risk of being contaminated during testing. The testing kit is also packaged with the machine. It is still a medical device, so a person must be trained to operate it, but it is easy to use, therefore making mistakes less commonplace. Originally, our machines were used for organ transplant testing, but with the rise of infectious diseases, we decided to incorporate this type of testing too.
We recently completed our work with Kyoto University, with whom we collaborated on the development of a high-precision pool-based mass screening system for SARS-CoV-2 (the COVID-19) detection using a fully automated genetic testing device. In the validation study, a total of 2,448 saliva and swab samples were tested, and the results showed a sensitivity of 97.1% and a specificity of 99.9%, demonstrating the high accuracy of this system.
For example, in a context where multiple people are tested at the same time, such as an airport, and in which a small minority of people test positive, while the majority are negative, eight samples are tested simultaneously, allowing for immediate detection of the positive samples.
You have a highly diversified product line-up. What product or products are you currently focusing on?
Our business model has changed in response to the COVID-19 pandemic. We didn’t produce reagents for PCR before, until we partnered with a European company providing them with the pre-packaged reagents. We have always been a machinery developer and have constantly asked ourselves what reagents should be used with our machinery for testing.
Your platform Bio System is an open system to provide solutions in a variety of fields, including oncology and stem cell research. Can you tell us more about it?
The Bio System is planned to extract very fine particles within the body: by extracting them using Magtration® technology or the cartridge reagent, we can apply the procedure in many fields, including disease detection. Our strengths are in sample preparation and conducting the diagnosis. To take advantage of our this strengths by establishing a mass production supply chain of our Prefilled Reagent Cartridge for Magnetic Bead Based Nucleic Acid Extractions, we are constructing the second plant of the Odate Reagent Center (targeted to start operation in the first half of 2022).
The reagent manufacturing capacity will be significantly increased from approximately 6 million tests/year to approximately 36 million tests/year to meet various genetic testing needs including PCR testing.
You have an in-house R&D department in Ichikawa, in Chiba prefecture, where you are tirelessly developing new products. What is the centre’s focus?
Recently, our development has moved in the direction of finding applications for the research and technology that we have accumulated over time. Unlike other companies, which use 96 microplates as a standard, we adopt a unique approach where we focus on each specific sample. Combined with our technologies, this approach allows us to create new approaches, such as detecting diseases that were previously difficult to diagnose.
How will you achieve clinical diagnosis using genes? Are you looking for partners to create new products for this specific market?
We now work with academic institutions, both internationally and domestically, whereas beforehand we were only working with other medical companies. We usually do as much as we can by ourselves, as we want to establish our one-of-a-kind technologies and devices.
Recently, you opened an Inspection center in Shinjuku, Tokyo. What is a purpose of the Establishment of "PSS Shinjuku Laboratory" which have opened last October as a Sanitary Inspection Center?
Ons and academia. In order to achieve corporate citizenship, we will also conduct PCR testing for COVID-19 infections from corporate entities and plan to establish a business cooperation group with the aim of "establishing a system where anyone can receive fast & accurate PCR tests anytime, anywhere" by deploying such facilities not only in Japan but also on a global scale.
On account of its ageing population, Japan is facing the need to focus more on healthcare prevention, rather than treatment. How are you catering to this trend?
Alzheimer’s, for example, is very difficult to treat, more so than cancer, and many pharmaceutical companies have invested trillions of yen to develop a drug to treat it, but to no avail. What is important is that if you can detect Alzheimer’s 10 or 20 years before its onset, then you are in a better position to treat it and potentially avoid suffering being caused by the disease. The same applies to cancer. Early detection is very important, and we are trying to utilise our technologies to create ways to detect these diseases.
You are present in Germany and the United States. Could you tell us why you chose these locations?
The reason we have businesses there is that we have partners in those countries. Japan is behind when it comes to understanding the need for PCR technology. Instead, there is a higher demand in the American and European markets, and we are working as an OEM provider with our partners in those locations.
What is your strategy to further expand internationally?
We have received many offers to be purchased by larger companies, but we have declined them because we want the freedom to develop what we like. Currently, we have distribution partners in the United States, Spain, Italy, France, Belgium, and Sweden, among others. In our work with overseas companies, we have been providing OEM products, but we are aiming to develop a PSS brand and sell our products directly. For now, we believe our best option is to have partnerships with agents who understand our products well and develop good distribution networks.
Imagine we come back in four years’ time for PSS’s 40th anniversary. What goals would you like to have achieved by then?
We want to enter niche fields that haven’t been entered yet. For example, the area of disease detection that we discussed earlier hasn’t been dealt with successfully. We want to provide technology that caters to and provides solutions for such frontier areas.