Pandemic Pivot Pays Off

MiRXES' Pandemic Pivot Pays Off

Armed with a wealth of experience from the pandemic, MiRXES is now set to return to its roots and focus on producing best-in-class multi-cancer early diagnostics.

2020 was anything but business as usual, but human ingenuity shone amid the uncertainty. Even as the coronavirus spread swiftly across the globe, scientists kept pace. When SARS-CoV-2 was discovered, researchers raced to sequence its genome. Institutions and companies subsequently developed diagnostic kits, drugs and vaccines—with markets rewarding them accordingly. In Singapore, pharmaceutical exports saw a 174 percent spike in April—making the pharmaceutical and biotechnology sectors one of the few bright spots in an uncertain economy.

Thus, MiRXES likewise pivoted to harness opportunities amid the pandemic. Though first and foremost a microRNA (miRNA) diagnostics company, we successfully leveraged our R&D and manufacturing competencies to mass produce the COVID-19 test, Fortitude. Within months, we ramped up our production capabilities to manufacture and export over five million units of Fortitude to over 45 countries.

But even as we focused our efforts on the Fortitude test kit, we continued to strengthen our portfolio of multi-cancer early detection tests. As MiRXES gradually enters the post-COVID world, we are hoping to return to our roots and prioritize the development of cancer diagnostics once more.

Cancer diagnostics on the rise

Worldwide, an estimated one in five men and one in six women will develop cancer during their lifetime. To reduce the number of lives lost to cancer, early detection is key. Accordingly, the emerging cancer diagnostics market has seen rapid growth. Worth US$6.3 billion in 2015, it is projected to more than double in the coming years, reaching US$14.8 billion by 2023. Despite the strong demand, early cancer diagnostic tests are still considered a relatively new area of research, with scarce availability in the market.

One novel method for effective and efficient cancer testing is harnessing biomarkers called miRNA that circulate in the blood. Given that miRNA levels markedly change during disease, these changes can be detected by our patented reverse transcription-quantitative polymerase chain reaction (RT-qPCR) technology. 

This world-leading RT-qPCR technology is the foundation of our flagship product GASTROClear, the world’s first miRNA blood test for the early detection of gastric cancer. Already approved for distribution in Singapore and Europe, GASTROClear is a literal standard setter in its field as the main product used to draft the Singapore Standard 656, the world’s first national standard for miRNA-based diagnostics.

The road ahead for MiRXES

MiRXES has long invested in building our capabilities in terms of talent, R&D, intellectual property (IP) and manufacturing. This year, our investments paid off during our rapid pivot to producing the Fortitude kits. With our own products back in the spotlight post-COVID, our RT-qPCR technology, miRNA discovery panels, test kits and proprietary algorithms represent a valuable and diverse IP portfolio. These assets act as strong barriers to entry against our competitor firms, ensuring that MiRXES will continue reaping returns for years to come.

In 2021, MiRXES is set to operationalize a new in-house diagnostics lab, further adding to our competitive advantage. Already, tests for cancers ranging from lung to breast cancer are in the pipeline and are expected to be ready in the next three to four years. When integrated, our patented tests may someday be able to detect different types of cancer in their earliest stages with just a single blood draw.

Another upcoming area of focus for MiRXES precision oncology. By identifying miRNAs for different kinds of the same type of cancer, we can develop highly-specific tests that allow oncologists to predict and map out a particular patient’s response to different treatments—with all this information available through one blood test.

Turning obstacles into opportunities

Despite the challenges posed by the pandemic, our temporary pivot to Fortitude diagnostic kits not only bolstered our manufacturing capabilities, but also allowed us to establish large-scale distribution networks. In 2021, we will build on this existing infrastructure to fast-track the commercialization of GASTROClear and other products in international markets. At the moment, one obstacle we foresee in achieving widespread use comparable with Fortitude’s is public hesitation to take early detection cancer tests.

Properly leveraged however, this roadblock will be a key opportunity for MiRXES in 2021. In the coming year, we intend to work with clinicians, governments and community partners in selected markets to educate the public on the importance of early cancer detection to accelerate clinical adoption. By doing so, we hope to promote and distribute more of our tests worldwide while staying true to our core mission to save lives. At the same time, this enables MiRXES to establish a strong brand presence that further serves as a barrier to entry against future competitors. As the pandemic has shown, every cloud has its silver lining.

Fortitude at the Forefront

Fortitude at the Forefront

Amidst the highs and lows of 2020, MiRXES managed to rise to the occasion and make our name on a global stage.

For many of us at MiRXES, 2020 can be summed up in a single word: Fortitude. Not only is Fortitude the name of the COVID-19 test kit we continue to manufacture to this day, but it also best represents the courage and resilience our company has shown amidst the coronavirus pandemic.

Having cemented our reputation as a world leader in miRNA technology with the 2019 release of GASTROClear—our early-detection test for gastric cancer—MiRXES started the new decade with a bang. Alongside our partners at the National University of Singapore (NUS), we organized the inaugural non-coding RNA (ncRNA) symposium in early January 2020, flying in renowned experts from all over the world.

In April, we also established a MiRXES subsidiary in Tokyo, Japan. As some of the world’s highest gastric cancer rates can be found in Japan, the expansion was the natural next step in our ongoing quest to deliver GASTROClear to people who will most benefit from the test.

Professor Takahiro Ochiya, MiRXES scientific advisory board member, speaking at the ncRNA Symposium in January 2020.

Rising to the COVID-19 challenge

Yet, less than a month after the resounding success of the ncRNA symposium, MiRXES—like many other companies around the world—suddenly had to face our most formidable foe yet: COVID-19.

By the first week of February, scientists at the Agency for Science, Technology and Research (A*STAR), Diagnostics Development (DxD) Hub and Tan Tock Seng Hospital (TTSH) had already developed the Fortitude test kit. Based on the reverse transcription-polymerase chain reaction (RT-PCR), Fortitude detects and amplifies SARS-CoV-2 genetic material found in patient samples.

With the rising tide of COVID-19 cases across the world, A*STAR approached MiRXES to scale up Fortitude’s production—completing technology transfer within one week. Working tirelessly even during Singapore’s circuit breaker, our team quickly repurposed production lines to manufacture 100,000 tests per week. By mid-year, we were producing one million tests every week, with Fortitude reaching the shores of over 40 countries worldwide.

While early cancer detection remains at the core of MiRXES, the pandemic represented a unique opportunity for the company to step up when the world needed our help the most. By staying true to our mission to save lives through innovative diagnostics—regardless of disease—it can be said that MiRXES rendered a ‘national service’ of sorts by mass producing the Fortitude test kits.

The MiRXES production team worked tirelessly, even through the Circuit Breaker, to produce enough Fortitude COVID-19 tests for our customers in over 45 countries worldwide.

We reap what we sow

Now that many parts of the world have largely passed the peak of COVID-19, we are now refocusing our efforts on cancer. Despite—or perhaps because of—the highs and lows of 2020, MiRXES is much more well-positioned to expand our cancer diagnostics portfolio. With our newfound experience gained from delivering Fortitude to various countries, we can apply the lessons learned to ensure the smooth release of GASTROClear in these same locations when the time comes.

This year has also proven right our decision to first prioritize building capability and capacity. Without the miRNA expertise, talent and facilities we had amassed through the years, MiRXES wouldn’t have been able to heed the call for Fortitude production as quickly as we did.

Beyond the pandemic’s shadow, 2020 also marked several milestones for the company. In two landmark studies published in Gut and PNAS, our scientists demonstrated the effectiveness of GASTROClear and our lung cancer detection tests. Along with our partners and the Singapore Manufacturing Federation, we also launched the world’s first-ever national standard for miRNA-based molecular diagnostics—the Singapore Standard 656. Taken together, the publications and standard represent the fruit of MiRXES’ focused efforts over the past eight years.

As 2020 comes to a close, the many achievements of MiRXES even in these trying times suggest that bigger and better things are in store in the years to come. Do continue to watch this space, and we wish everyone a delightful holiday season ahead!

The genesis of GASTROClear

The genesis of GASTROClear

As the world’s first molecular blood test for detecting gastric cancer, GASTROClear could play a pivotal role in stopping the deadly disease in its earliest stages.

GASTROClear is the world's first molecular blood test for early detection of gastric, or stomach, cancer.

Whenever we fall sick, we often associate each illness with a characteristic set of symptoms. Constantly sneezing with a bad rash? Must be allergies. Stuffy nose and sore throat? Likely the flu. Bloodshot eyes? Likely conjunctivitis or pink eye. But not all diseases come with obvious symptoms.

In fact, the most insidious diseases have no symptoms at all, especially at the beginning. Take gastric or stomach cancer, which caused around 783,000 deaths worldwide in 2018. Early stages of gastric cancer can be asymptomatic, with diagnosis often only occurring after the cancer has spread to other organs. At this point, the prognosis for gastric cancer is quite poor, as only one in three patients survive past five years.

To lessen the number of lives lost to gastric cancer, early detection and treatment is key. One test making early detection possible is MiRXES’ GASTROClear, which measures gastric cancer biomarkers called microRNA (miRNA) found in blood. Launched in Singapore in May 2019, GASTROClear made history as the world’s first approved molecular blood test for gastric cancer. Here’s the story behind our game-changing product.  

Mining for miRNAs

National screening programs have become the norm in places like Japan and South Korea, where up to 40 out of 100,000 people are diagnosed with gastric cancer . Currently, the gold standard method for detecting gastric cancer remains endoscopy, which involves the insertion of long, flexible tube down the throat and into the stomach. While effective, endoscopy is a costly and invasive procedure, posing barriers to screening uptake.   

Given the need for a less invasive and cost-effective gastric cancer screening test, harnessing miRNAs—small RNA molecules that regulate gene expression—seemed like a promising alternative. After all, abnormal miRNA levels are often associated with disease. Teaming up with the Singapore Gastric Cancer Consortium, the national platform Diagnostics Development Hub led by the Agency for Science, Technology, National University Hospital and Tan Tock Seng Hospital, we sought to develop a non-invasive miRNA-based gastric cancer test.

Applying our patented reverse transcription-quantitative polymerase chain reaction (RT-qPCR) technology, we first identified specific miRNAs whose levels markedly changed with the onset of gastric cancer. In a three-phase, multi-center study spanning across Singapore and Korea, MiRXES and our partners used RT-qPCR to profile miRNAs found in the blood serum of 682 subjects and discover any unusual changes in miRNA levels.

From 578 prospective miRNAs, we eventually pinpointed 11 key miRNA candidates whose fluctuations were associated with gastric cancer and used that information to develop a RT-qPCR panel that specifically measured these miRNAs. Through a proprietary algorithm, we analyzed the levels of all 11 miRNAs candidates to generate a cancer risk score personalized to each patient. A score of 50 or above suggests a greater risk of having stomach cancer, while scoring 40 or below indicates otherwise normal miRNA levels.

Validating the test—dubbed GASTROClear—in over 4,500 subjects who had also gone through endoscopy, our results showed that GASTROClear was able to detect 87.5 percent of stage I and 89.5 percent of stage II gastric cancers respectively.

The development of GASTROClear involved MiRXES' partners from the Singapore Gastric Cancer Consortium, A*STAR, National University Hospital, Tan Tock Seng Hospital, and other international collaborators.

Setting the standard

For all the convenience and efficiency offered by GASTROClear, it should be noted that the test is not meant to fully replace endoscopies—instead, it complements these screenings. Primary care physicians, for instance, can use the test to assess a patient’s risk and from there, determine if an endoscopy is needed. For patients who are reluctant to do endoscopies, results from GASTROClear can serve as a much-needed push to take the plunge. Indeed, compared to a no screening scenario, GASTROClear-based screening is likely to lead to better clinical outcomes, making it ultimately more cost-effective.

Since the test’s landmark launch in 2019, GASTROClear has achieved another significant milestone. It’s literally setting the standard as the main product used to draft the Singapore Standard 656, the world’s first national standard for designing, developing and validating microRNA-based diagnostics. GASTROClear has also been approved for use by Singapore’s Health Sciences Authority and has received CE marking for distribution in the European Union.

Buoyed by GASTROClear’s success, our team at MiRXES is now also developing similar miRNA-based blood tests for lung, breast, colorectal, ovarian and liver cancers. While GASTROClear may have been the first of its kind, it certainly won’t be the last.