In the midst of the COVID-19 pandemic, the importance of testing is evident. As many countries seek a sustainable economic recovery through the implementation of the Triple T (testing, tracking, and testing) strategy, the demand for COVID-19 diagnostic test kits is growing significantly. Therefore, the focus lies on diagnostic companies that can assist governments in reducing the spread by increasing testing capabilities to meet the testing demand in a country.
JN Medsys is a Singapore-based diagnostics company, which has responded to the COVID-19 pandemic by developing multiple types of COVID-19 test kits. Their products are currently marketed locally as well as internationally. Jia Jhing Sia, Research Analyst at AcuBiz Consulting discusses with Dr Johnson Ng, Founder, and CEO of JN Medsys about the emerging market trends in COVID testing and JN Medsys’ business strategies moving forward.
This is the first of a series of interviews with Singaporean companies regarding COVID-19 testing. Singapore has recently been recognised as having the highest testing rate among the ASEAN countries. Our objective is to develop insights on the government’s strategies for meeting this increasing demand and assess how the domestic diagnostic companies are rising to the challenge of tackling the pandemic both locally and globally.
JJ, AcuBiz:JN Medsys is one of Singapore’s leading biotechnology companies. Could you please give us a brief introduction to your company’s background?
Dr Johnson Ng: We are a Singapore-based company, primarily making instruments and kits for genomic analysis. 10 years ago, the company was founded and we decided to come up with a fast, easy, and innovative way to do digital PCR using a high-density chip. Back then, digital PCR was very new and the traditional real-time quantitative PCR was more common.
It took about 4-5 years to develop the idea into a product and we launched our first product in 2016. At that time, we were one of the first Asian companies to launch a digital PCR (dPCR) product and only 2-3 other companies (mostly American companies) sold dPCR products. Even now, we are still one of the few companies globally to have a dPCR product. Since then, we have expanded our product development and manufacturing capabilities to consumables and kits primarily for our dPCR instruments.
JJ, AcuBiz: Could you give a brief comparison of dPCR and conventional qPCR?
Dr Johnson Ng: Conceptually, dPCR is just like qPCR. The difference is that qPCR is run in a bulk solution of 15-20 microliters while in dPCR, the solution is broken up into 10,000 partitions, each containing about 1.5 nanoliters. Each partition contains either 0 or 1 copy of the targeted gene. These partitions undergo thermocycling and amplification simultaneously. End-point detection is then done to identify the partitions that give out a fluorescent signal, which identifies the presence of a PCR product. Each partition contains either 0 or 1 copy of the targeted gene.
This partitioning and amplification offer dPCR two main benefits for the quantification of PCR. The first is absolute quantification. By looking at the results of the particular reaction, we are able to deduce the exact number of copies of DNA that are present in the solution. This is not possible with traditional PCR as quantification is done on qPCR by adding a relative standard and comparing the cycle threshold (CT) values to get an estimate of the quantity of DNA present. Absolute quantification is powerful as it makes the results very accurate.
The second advantage is increased sensitivity, especially for the detection of a rare mutation. In normal PCR, the rare mutation might not be detected because it can be masked by the high background of normal DNA. With dPCR, this is not a problem as you are portioning out all the different DNAs into individual partitions which contain either 0 or 1 copy of the gene. So, it is very easy to detect rare mutations.
JJ, AcuBiz: How has JN Medsys responded to the COVID-19 pandemic?
Dr Johnson Ng: When COVID struck early this year, we diverted our resources to developing a COVID-19 PCR kit. Incidentally, the first kit we developed was based on conventional qPCR because compared to dPCR, the development, implementation, and commercialization are faster and easier for a qPCR test kit.
We developed the kit in February and in March, we received Singapore’s Health Sciences Authority (HSA) approval. We were the sixth company to receive HSA approval in Singapore. After that, we could launch the qPCR kit in Singapore. Currently, we have several different versions of the kit, which include an improved version of the qPCR kit and a dPCR version of the kit.
JJ, AcuBiz: How do you compare these two types of PCR tests in terms of market demand, sensitivity, and throughput? Also, when do you think we can see dPCR being more widely used in the market?
Dr Johnson Ng: In terms of market demand, qPCR tests for COVID testing are in higher demand than dPCR because, under the current situation, everyone wants to use tried and tested methods as much as possible – or follow WHO’s recommendation or use what everyone else is using. No one wants to take the risk and experiment with cutting-edge technologies that are not yet popularly used. I think that qPCR is rightly the main default method of choice for COVID testing because it has lower costs and is easier to use, especially in countries with limited resources.
With dPCR, however, absolute quantification allows us to know the viral load of an infected COVID-19 individual. This is helpful because the viral load may be able to tell us how seriously the person is infected and if the treatment is effective and the person is recovering. The increased sensitivity also helps us to carry out pool testing without compromising too much on sensitivity.
In pool testing, we pool 5-10 patient samples together in one reaction to increase the throughput of COVID testing. As the throughput for dPCR is not as high as qPCR, pooling the samples will help to overcome the throughput limitation of dPCR. This is a major advantage for the labs that are using dPCR for COVID-19 testing, but the majority of the labs are still using qPCR.
The question of when dPCR will be more widely used in the market boils down to whether the labs and end-users are technically equipped to adopt high-end and complex technologies. I think as COVID-19 cases are stabilizing in more places now, the labs and end-users will be looking to explore and implement new technologies that will help to improve their workflow, throughput or quality of the results. We have seen how labs invested heavily in qPCR so funding, probably, is not a major issue.
JJ, AcuBiz: In terms of the testing trends, what are the common testing methods used in Singapore? In most markets, there is a high demand for rapid tests for COVID-19. Is it true for Singapore? Do you think the availability of cheaper rapid tests (antigen and antibody tests) can impact the demand for molecular diagnostics for COVID-19?
Dr Johnson Ng: The market for molecular testing used to be very small in Singapore. Before COVID-19, the majority of tests being carried out were traditional tests like clinical chemistry tests, blood tests, and HIV tests. DNA testing was very niche because its demand was only for selected applications. As the market was not large enough, it was difficult for labs to offer molecular testing to be sustainable. In order to include molecular diagnostics in the lab business offerings, they need to invest in a certain amount of skills and facilities to make it viable and profitable.
COVID-19 has changed a lot of things and it is unprecedented to have this scale, volume, and capacity of PCR testing available. Currently, every single lab in Singapore is focused on COVID testing. Hospital and public labs diverted resources to focus on doing COVID tests. Private labs have also ramped up their capacity by bringing in new machines, etc. for COVID testing. While in the short term, the demand for other types of testing has been lowered, in the long term, as COVID stabilizes and nations learn how to cope with the situation better, other types of molecular testing for cancer and other diseases will have to come back in.
Molecular diagnostic tests and rapid tests are two different technologies for solving different problems and for providing different solutions. For COVID testing, PCR tests detect the presence of the virus while rapid tests detect for past infection and immune response. Even beyond the scope of COVID-19 tests, there will be a use for both molecular testing and point of care serology or immunology tests. So, I don’t think the demand for molecular diagnostics has been impacted by rapid tests.
JJ, AcuBiz: Your products have also recently received the CE-IVD mark from the EU. Which are the other international markets you are targeting next for your COVID-19 tests? What are the key challenges have you faced while expanding to new markets in terms of meeting the demand, regulatory requirements, pricing, etc.?
Dr Johnson Ng: JN Medsys exports globally and some of these markets include Latin America, Southeast Asia (SEA), India, and Africa.
Very early on, in March, there were supply issues as the pandemic was exploding globally and there was a sudden demand for test kits that the suppliers couldn’t meet. To increase our production capacity, we expanded and got extra space, we hired more people and streamlined the manufacturing process to make us more efficient. To overcome the lead time bottleneck for the raw materials to arrive, we decided to manage our suppliers better and order in advance to ensure we don’t have a supply chain problem. This also included managing our cash flow better as most suppliers require that we pay in advance.
Currently, such issues are solved, and we keep a certain amount of inventory to make sure we have enough stock and supply to meet our orders. Our current production capacity is 200,000 tests a week. We are ready to ramp up the capacity if necessary, should the demand goes up.
Additionally, we had to get regulatory approval almost everywhere we targeted. For example, in Ecuador, Columbia, and Argentina, we and our partners spent quite a bit of time to get regulatory approval. As some countries were quite bureaucratic, this also added to the problem of getting regulatory approval.
To reduce the costs, we made our distribution processes more efficient by obtaining our supplies directly from the manufacturer. As the volume was large enough, we also bought our supplies in bulk and reduced shipment costs as we may require the items to be shipped in cold chain or dry ice which is more expensive than conventional shipping. In Singapore, the government currently pays for every test but every market is different. Eventually, travelers might have to bear the costs of the tests when traveling.
JJ, AcuBiz: Globally, what are the key trends in the COVID-19 testing market? How do you think this segment will evolve in the coming months in the Asia Pacific markets as well as the global markets?
Dr Johnson Ng: As the COVID situation is very fluid, it is really important to remain flexible. We have seen the epicenter of the outbreak constantly shifting from China, to Korea, then to Europe, SEA, Latin America, and India and currently we see second waves occurring as well. This highlights that COVID is a global problem and therefore there will always be demand for COVID test kits. I believe that as countries open up and cases stabilize, the demand for the test kits will also shift from managing the outbreak and containing the infection to surveillance, such as checking that the airline crew is not infected and that travelers are virus-free.
JJ, AcuBiz: Lastly, where do you see Singapore’s COVID-19 situation to be in the next 3 months?
Dr Johnson Ng: I think that COVID is not going to go away. Second and third waves occur as people become fatigued after lockdown and let down their guard. But I think more countries are now better equipped to cope and manage the subsequent waves of the outbreak. However, some countries will continue to struggle especially if they have limited testing capacities or their hospital systems are stretched or those countries that refuse to implement social distancing measures and mask-wearing. I think the pandemic will be more manageable as we see more countries implementing these rules to help contain the spread.