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The genesis of GASTROClear

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.  

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

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.

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