AsianScientist (Dec. 11, 2020) – In early 2020, Singapore’s brightest scientific minds were facing an unprecedented race against time. To prevent the COVID-19 from taking hold in the country, a test that could accurately detect SARS-CoV-2 was needed—and fast. With no time left to lose, scientists from the Agency for Science, Research and Technology (A*STAR) and Tan Tock Seng Hospital worked round the clock. By the first week of February, the Fortitude Kit was unveiled.
Fortitude is notable for being Singapore’s first “ready-made” hospital lab COVID-19 diagnostic that received Singapore Health Sciences Authority’s (HSA) Provisional Authorisation for clinical use. From start to finish, the whole process of developing Fortitude took up less than a month. Considering that diagnostics development typically takes over a year, the kit’s lightning-fast deployment is a remarkable feat.
As CEO of the Diagnostics Development (DxD) Hub, a national platform hosted by A*STAR, scientist-entrepreneur Dr. Sidney Yee played a pivotal role in bringing Fortitude to market. From optimising the assay and establishing the production process, DxD Hub provided the kit’s finishing touches.
“DxD Hub serves as the national productization platform by providing end-to-end expertise in taking a diagnostic product from bench to bedside,” explained Yee. “[We] facilitate the optimization, validation, development and pilot production of diagnostic products—and even local regulatory approval.”
Since DxD Hub’s launch in 2014, it has worked with over 30 companies to bring diagnostic products to the market. If developing diagnostics on the daily sounds like a tough job, that’s because it truly is. According to Yee, about 80 percent of products fail feasibility studies due to issues surrounding assay reproducibility and market viability. Amid the backdrop of a global pandemic, timelines have also become increasingly tight.
“One key factor in successfully developing Fortitude was DxD Hub’s active and constant engagement with stakeholders like the Health Sciences Authority and National Centre for Infectious Diseases even during peacetime,” said Yee.
Though she describes the challenges her team faces as “endless,” Yee and her team have so far successfully fought through the various fires. One notable challenge DxD Hub has managed to overcome is patient recruitment.
“A key part of productization is validating the clinical performance of your product,” she explained. “As Singapore is a small country, the population size and disease prevalence rates sometimes pose a real challenge.”
To address these limitations, Yee and her colleagues actively tap onto local and international networks of clinical key opinion leaders that they have amassed over the years. Not only does this solve DxD Hub’s problem of patient recruitment, but it also facilitates the product’s establishment in their collaborator’s countries.
Under Yee’s leadership, DxD Hub has co-developed and commercialized numerous products in the fight against COVID-19. Beyond Fortitude, other noteworthy examples include the joint RESOLUTE 2.0 and RAVE system that automates key steps in COVID-19 sample processing.
But DxD Hub still has a crucial role to play, even after the pandemic finally subsides.
“Part of A*STAR’s charter is growing and strengthening the local industry,” said Yee.
By fostering collaborations with public agencies and universities to address unmet clinical needs, she hopes to create a vibrant diagnostics devices ecosystem in Singapore.
Reflecting on her experience, Yee shared, “It’s been very humbling. Surround yourself with people who can help with different aspects, such as regulatory, financials and market channels.” She added, “There will also be many trade-offs and sacrifices to be made. Do not expect a safety net.”
Her final piece of advice?
“Be ready to make a sales pitch anytime.”
Spoken like a true scientist-entrepreneur, indeed.
Copyright: Asian Scientist Magazine.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.