Founded in 2014, we are a Singapore-headquartered micro ribonucleic acid (“miRNA”) technology company that is making diagnostic solutions for the screening of diseases accessible across our key markets in Asia, including Singapore and China. As of the Latest Practicable Date, we had one Core Product (namely, GASTROClearTM), two other commercialized products (namely, LUNGClearTM and FortitudeTM), and six product candidates at pre-clinical stage, as illustrated in the chart below. GASTROClearTM, our Core Product, is a blood-based miRNA detection panel consisting of 12 miRNA biomarkers for gastric cancer screening. GASTROClearTM has been successfully commercialized in Singapore after obtaining Class C in vitro diagnostic (“IVD”) certificate from the Health Sciences Authority of Singapore (the “HSA”) in May 2019.
WE MAY NOT BE ABLE TO ULTIMATELY MARKET GASTROCLEARTM OUTSIDE SINGAPORE, ULTIMATELY DEVELOP AND MARKET LUNGCLEARTM AS AN IVD PRODUCT, OR ULTIMATELY DEVELOP AND MARKET ANY OR ALL OF OUR SIX PRODUCT CANDIDATES, SUCCESSFULLY.
We are a provider of effective, non-invasive and affordable blood-based miRNA test kits for the early detection of cancer and other diseases, according to Frost & Sullivan. According to Frost & Sullivan, we are one of the few companies globally that have obtained regulatory approval for IVD product in the molecular cancer screening industry*, and we are also the world’s first and only company that has obtained regulatory approval for IVD products of molecular gastric cancer screening.
We are a market player within the liquid biopsy sub-category of the overall disease screening methods market. Our Core Product GASTROClear. is one of the screening methods for cancer detection, focusing specifically on miRNA-based liquid biopsy. Cancer screening involves testing individuals at risk of developing cancer to detect the disease early or prevent complications, with sensitivity and specificity being key measures of a test’s effectiveness.
Key cancer screening methods include protein-based markers, imaging tests, endoscopic exams, and liquid biopsy, an emerging molecular diagnostic method that uses liquid samples like blood or urine to detect cancer biomarkers such as circulating tumor cells, ctDNA, and miRNA.
Our Company was founded by our co-founders, Dr. TOO Heng Phon, Dr. ZHOU Lihan and Dr. ZOU Ruiyang, who pioneered the invention of miRNA polymerase chain reaction (“PCR”) technology with high sensitivity, specificity and reproducibility and proved the scientific and clinical significance of applying such technologies to the screening and early detection of various diseases.
Early Detection and Precision Multi-omics Business Segment
Early Detection Business Sub-segment
Within Early Detection business sub-segment, our primary focus is on developing, manufacturing and commercializing miRNA early detection test kit products that are accessible to the mass market. These test kit products take the form of simple blood tests performed on PCR instruments to detect miRNA biomarkers associated with various diseases. Under our Early Detection business sub-segment, as of the Latest Practicable Date, we had one Core Product (namely, GASTROClearTM), another one commercialized product, and six product candidates at pre-clinical stage.
Our Core Product
GASTROClearTM, our Core Product, is the first and only approved molecular IVD product for gastric cancer screening globally, according to Frost & Sullivan. GASTROClearTM is a blood-based miRNA detection panel consisting of 12 miRNA biomarkers for gastric cancer screening. GASTROClearTM has been successfully commercialized in Singapore after obtaining Class C IVD certificate from the HSA in May 2019, and has obtained the CE-IVD Mark in November 2017. In May 2023, GASTROClearTM obtained breakthrough device designation from the Food and Drug Administration (the “FDA”) of the United States (the “U.S.”), which makes us the first to obtain the breakthrough device designation from the FDA for blood-based miRNA diagnostic test as well as for molecular diagnostic test for gastric cancer. GASTROClearTM has also been commercialized as an LDT service in Singapore (through third-party diagnostic laboratories) since 2019 and in Singapore and other SEA regions (through our diagnostic laboratory in Singapore) since October 2022. GASTROClearTM, being a non-invasive screening solution for gastric cancer suitable for large scale clinical screening, is used as a complementary test to the gold standard for gastric cancer screening. Furthermore, our experience in developing GASTROClearTM has been used as a valuable reference and complementary standard for the drafting of miRNA molecular detection industry standards, including the SS 656: 2020 Singapore standard, which sets out the key considerations for the design, development, and performance evaluation for miRNA-based clinical diagnostic assays, thereby demonstrating its outstanding clinical performance.
MiRNAs are small, non-coding RNA strands typically with 19 to 24 nucleotides in length that regulate genes that are associated with disease diagnosis. Functioning through binding to and degrading RNA transcripts of protein-coding genes, miRNAs play an important role in gene regulation, being critical molecules in maintaining regular biological processes. Abnormal levels of miRNA have been found to be associated with cancer and other diseases, and miRNA profiles can reveal an individual’s likelihood to develop certain diseases and predict drug responses. MiRNA molecules are difficult to detect due to their small size, and reverse transcription of quantitative polymerase chain reaction (“RT-qPCR”) is among the methods that are commonly used in detecting or quantifying miRNA, which allows the detection of rare transcripts and the observation of small variations in gene expression.
We completed a large-scale prospective clinical trial for GASTROClearTM with 5,282 subjects in Singapore, being one of the few largest prospective clinical trials globally for cancer screening that have been conducted, according to Frost & Sullivan. GASTROClearTM is equipped with our modified stem-loop medical reverse transcription quantitative polymerase chain reaction (“mSMRT-qPCR”) technology and is capable of rapid detection of 13 samples per use, with the detection results being available within four hours in a PCR laboratory. Our advanced miRNA detection and quantification capabilities are based on our mSMRT-qPCR technology and rely on our unique three-primer approach, which is able to yield precise amplification of target miRNAs.
We completed the registrational clinical trial of GASTROClearTM in China in November 2023 and submitted a registration application to the NMPA in December 2023. We expect to launch GASTROClearTM as an IVD product in China in the first half of 2025. After obtaining the NMPA approval, we plan to further develop GASTROClearTM through post-approval studies including (a) clinical studies including a randomized controlled trial (“RCT”) that compares gastric cancer screening programs in China, and (b) the clinical studies for the collection of real-world evidence to support the future recognition of GASTROClearTM by clinical guidelines. As of the Latest Practicable Date, we assembled a dedicated team in China with 47 personnel for commercializing GASTROClearTM in China. We plan to recruit additional 50 and 50 sales staff in 2025 and 2026, respectively, to support our commercialization efforts of GASTROClearTM in China. We also project to upgrade and expand the manufacturing facility in China in anticipation of the increasing demand for mass production after we obtain the approval from the NMPA.
In Japan, we have completed a clinical study in July 2022 to assess the applicability of GASTROClearTM on the Japanese population and have also been in consultation with the PMDA to explore an IVD approval of GASTROClearTM in Japan. Subject to our ongoing communication with the PMDA, we plan to carry out additional clinical studies to generate further clinical data as required, and submit a registration application to the PMDA. We also launched GASTROClearTM as a LDT service in July 2024. Moreover, in the U.S., we have had ongoing discussions with the FDA regarding our pre-submission plan with respect to the pre-market approval (“PMA”) application to the FDA and discussed with the KOLs on the regulated clinical trial requirements, and are formulating the regulated clinical trial design in the U.S. and plan to use such regulated clinical trial results for the PMA application of GASTROClearTM. We expect to initiate the pre-submission consultation with respect to the specific trial design to the FDA in the second half of 2025 upon completion of our trial designs.
For details, please see “Business – Our Early Detection and Precision Multi-omics Business Segment – GASTROClearTM – Our Core Product – Further Development Plan.” For other Southeast Asian countries other than Singapore, we plan to launch the localized LDT services in the first half of 2025 in Philippines and Malaysia. In Thailand, we submitted an application to the Thailand Food and Drug Administration for an IVD approval of GASTROClearTM in January 2024, and received the approval in February 2024. We launched GASTROClearTM as an IVD product in Thailand in December 2024. Additionally, we are preparing to collaborate with a local company in Indonesia to launch a bridging study in the first half of 2025 and to submit our registration application in the second half of 2025, with the aim of registering and manufacturing GASTROClearTM as an IVD product locally in the Indonesian market.
Source: Mirxes-B (02629) Prospectus (IPO Date : 2025/05/15) |