November 24, 2020
Photos by: Caroline Chia | Words by: Stacey Rodrigues
(Photo above) Ms Melissa Chua, a research officer, prepares a PCR (polymerase chain reaction) test by blending reagents that will be used to mix with mucus derived from nasopharyngeal swab samples. These mixtures are later placed in a machine to duplicate genetic material to identify if a patient has Sars-CoV-2.
You’ve seen the all-too-familiar wince, when an extra-long cotton swab is gently pushed into the nostrils of patients to find out if they are Covid-19 positive. These nasopharyngeal swabs have become a ubiquitous symbol of this pandemic.
Testing for Covid-19 used to be an activity that took place in specialised hospitals or quarantine areas. Now, even your neighbourhood GP can administer a Covid-19 test. Testing is also becoming the 2020 version of being “carded” before entering a karaoke lounge or nightclub.
But before testing became a normalised activity, the process of creating these tests and establishing a production flow that could keep pace with the spread of the pandemic was hardly an everyday affair.
WhatAreYouDoing.sg spoke to Dr Zhou Lihan, co-founder and CEO of MiRXES, the biotech discovery and diagnostics company behind the production of the Covid-19 Fortitude Kits, to find out what went into the making of these test kits.
(Above) Up to 1,200 vials are filled and capped each day. The Fortitude Kit (v2.1) has undergone updates to ensure the test keeps up with mutations detected in the virus genome.
WAYD: What were your first reactions when you were informed about Covid-19?
Dr Zhou Lihan: When we were first informed about the virus, we thought about how the outbreak would affect research activities and cancer diagnosis. This was because our business was then focused around providing solutions for life science research and early detection of cancer.
As the virus spread and became a pandemic, our partner research labs around the world shut down, clinical studies were suspended, and the number of patients going for diagnostic procedures dropped.
When the virus reached Singapore’s shores, we began preliminary discussions around developing our own diagnostic tests for Covid-19. However, we were soon approached by our long-time collaborators in A*STAR who asked if we could support the mass production and distribution of the Fortitude Kit Covid-19 test. We responded to the call without hesitation.
WAYD: How did MiRXES work with developers to produce the kit?
Dr Zhou: Once we were called upon by A*STAR to mass produce the Fortitude Kit in February, we started the process of technology transfer that same afternoon. We dropped most of our projects on hand to focus on this urgent task, pulling in manpower from our R&D and manufacturing teams. We had multiple discussions with the researchers from A*STAR and Tan Tock Seng Hospital (TTSH), as well as our partners from the Diagnostics Development (DxD) Hub, a national initiative led by A*ccelerate, the commercialisation arm of A*STAR. DxD Hub supported the optimisation, verification, validation and pilot production of these tests. We have been partners with DxD Hub since 2014. Our close working partnership allowed us to complete the technology transfer process within one week and begin mass production of 100,000 tests a week.
(Above) MiRxes had to hire additional staff to assist with tasks like labelling and packing vials. This process has since been automated.
WAYD: What were your biggest concerns and challenges in producing the kits?
Dr Zhou: Our biggest concern was getting a quality test that would have high performance whichever lab it is deployed to, in any country. There was also great urgency in getting the test to local hospitals and labs, so that Singapore was ready when the first wave of Covid-19 hit us.
Challenges included working to set up the production line under tight timelines while making sure all processes are followed to ensure the quality and accuracy of the test kits. As the Covid-19 outbreak spread and affected international logistics and supply lines, it also became harder to source and plan for delivery of the necessary raw material and supplies.
To overcome the production challenges, we worked very hard round the clock in the initial stages to set up and validate all the necessary processes, motivated by the thought that we need to get the test kits to our local hospitals as soon as possible.
Many of our team members took on additional roles and responsibilities, working 12-hour shifts while practicing safe-distancing measures and split-team operations, to ensure that we get the test kits delivered as soon as possible to labs which needed them, both locally and overseas. Their hard work and personal sacrifice made it possible for us to keep the manufacturing site operating 12 to 16 hours every day, even during Singapore’s Circuit Breaker period.
(Above) Many team members at MiRXES took on additional roles and responsibilities, working 12-hour shifts while practicing safe-distancing measures and split-team operations, to ensure test kits were delivered as soon as possible to local and overseas labs.
WAYD: How do you feel about the significance of your work in managing the spread of the virus?
Dr Zhou: We are humbled that the capabilities that MiRXES had built up in Singapore since 2014 could be used in this way to help manage the spread of the virus. We are just playing a small part as a homegrown biotech company in this joint effort with our partners and the rest of the research and biotech community in Singapore and around the world. We are glad to see many in the research and biotech community stepping up to meet the unprecedented challenge of the pandemic, using all the medical, scientific and technological advances we can muster.
WAYD: What’s next for Covid-19 testing?
Dr Zhou: Our focus remains in producing PCR (polymerase chain reaction) tests like the Fortitude Kit which remains the gold standard for Covid-19 detection because of its superior accuracy. We have been working with partners to offer integrated solutions for testing which cover the entire process from sample collection to test result.
The current version of the Fortitude Kit (v2.1) has already undergone updates to ensure the test keeps up with mutations detected in the virus genome.
We are working on solutions, from our own R&D and in partnership with other developers, which meet the needs of various testing workflows in different labs across the world. For example, we have validated the Fortitude Kit for use on various automation solutions which labs use to minimise hands-on time for technicians, giving more accurate results in a safer manner.
As the winter months and flu season approach in the Northern hemisphere, we are also developing a syndromic panel PCR test which can determine if a patient suffering from flu-like symptoms has Covid-19 or another virus like Influenza A, Influenza B, or respiratory syncytial virus (RSV).
(Above) Dry ice is packed into styrofoam containers to keep temperatures at -20 deg C when test kits are transported out of the lab and distributed. These kits have been given out to some countries in Asia (including Indonesia, Myanmar, Philippines, Brunei, Sri Lanka, India, and Mongolia) as part of humanitarian efforts.
