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Mirxes receives FDA’s Breakthrough Device Designation for GASTROClearTM to advance blood-based cancer early detection
SINGAPORE, 10 August 2023 – Mirxes Corporation USA, the wholly owned subsidiary of Mirxes Pte Ltd, a Singapore-headquartered RNA technology company that is making diagnostic solutions for the early detection of diseases accessible on a global scale, announced today that its flagship product GASTROClearTM, a PCR-based in vitro diagnostic test for early detection of gastric (stomach) cancer, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). Globally, this marks the first time that 1) a blood miRNA test, 2) an in vitro diagnostic (IVD) test for early detection of gastric cancer, and 3) a molecular in vitro diagnostic test developed in Southeast Asia, has received a Breakthrough Device Designation from the U.S. FDA. This designation is only granted to certain medical devices that address unmet needs and provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions such as cancer.
Launched in 2019, GASTROClearTM is the world’s first molecular blood test for the early detection of gastric cancer, enabling physicians and patients to act early before symptoms occur. The disease is the fourth most common cause of cancer death worldwide and a major cancer burden in Asia. WHO projects gastric cancer incidence to increase from 1.09 million new cases in 2020 to 1.81 million in 2040, with 75 per cent of new cases diagnosed in Asia. Gastric cancer detected early at asymptomatic stage can be cured with affordable treatment costs. Currently, most gastric cancers are diagnosed at late stage due to the lack of accurate and accessible mass screening tools. GASTROClearTM was developed and manufactured in Singapore through a seven-year public-private partnership by physicians and scientists at the Agency for Science, Technology, and Research (A*STAR)’s Bioprocessing Technology Institute (BTI), Diagnostics Development Hub (DxD Hub), the Singapore Gastric Cancer Consortium (SGCC), the National University of Singapore (NUS), the National University Hospital (NUH), Tan Tock Seng Hospital (TTSH) and Mirxes.
GASTROClearTM was first approved by the Singapore Health Science Authority (HSA) in 2019, after a prospective clinical validation in more than 5,200 patients in Singapore. More recently, Mirxes, in collaboration with seven academic clinical institutions in China, conducted a large prospective clinical trial involving more than 9,000 patients, for registration of GASTROClearTM with China’s National Medical Product Administration (NMPA). Post-pandemic, Mirxes is making GASTROClearTM accessible in key Asia Pacific markets and is evaluating partnership to enable its launch in the United States.
Dr. ZHOU Lihan, Co-founder and CEO, Mirxes, said, “It’s a privilege for GASTROClearTM to be granted Breakthrough Device Designation by FDA. Today, GASTROClearTM is available in six Asia Pacific markets and can be made accessible to millions of potential customers through PCR capabilities leapfrogged by the pandemic. The Breakthrough Device Designation further validated the novelty and clinical impact that GASTROClearTM can deliver in the field of gastric cancer early detection. As part of the Breakthrough Program, we are looking forward to interacting with FDA’s experts to obtain their continuous guidance during our pre-market review.”
The goal of the FDA Breakthrough Device Program is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment and review, while preserving the statutory standards for pre-market approval.[i] Under the Program, GASTROClear™ could become available as an early detection test option sooner for people at high-risk for gastric cancer.
Professor YEOH Khay Guan, Lead Principal Investigator of the Singapore Gastric Cancer Consortium and Senior Consultant in the Division of Gastroenterology & Hepatology, Department of Medicine, NUH, said, “The FDA Breakthrough Device Designation for GASTROClearTM marks a notable advance in the fight against gastric cancer. This non-invasive blood test has the potential to transform our management of this devastating disease, allowing us to identify individuals at high risk even before symptoms appear. Early detection enables curative treatment and will significantly improve survival for this otherwise fatal disease.” He is also the Kishore Mahbubani Professor in Medicine and Health Policy, Department of Medicine, NUS Yong Loo Lin School of Medicine.
Prof. YEO Yee Chia, Assistant Chief Executive of A*STAR’s Innovation & Enterprise Group said, “We are proud that Mirxes, an A*STAR spinoff strongly supported by NUS, has received the U.S. FDA’s validation of their flagship product GASTROClearTM. We are glad to see that this Singapore technology, developed by Mirxes’s founders as scientists at A*STAR’s Bioprocessing Technology Institute, DxD Hub, and our ecosystem partners, has reached a new product milestone. A*STAR will continue to support our spinoffs and foster strong ecosystem partnerships to accelerate the commercialization and delivery of innovative healthcare solutions that benefit society.”
“This designation granted to GASTROClearTM is a remarkable recognition that early diagnosis of gastric cancers is possible using non-invasive blood tests. The liquid biopsy approach will enable early interventions which can lead to better management of gastric cancer, and improve the quality of life and survival. The journey, though long, has been worthy, and is the fruit of the labor of a number of clinicians and scientists working closely together, sharing a common vision of translating research into societal impact,” said Associate Professor TOO Heng-Phon, Department of Biochemistry and NUS Centre for Cancer Research (N2CR) at the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine). He is also the Co-founder, Chief Scientific Advisor and Non-Executive Chairman, Mirxes.
Dr. GOH Liuh Ling, Senior Principal Scientific Officer, Personalized Medicine Service, Tan Tock Seng Hospital said, “Screenings can help detect cancers early. This major development will be pivotal in ensuring that patients have timely access to early testing, detection, and increase their chances of recovery. Our joint collaboration in providing screenings for gastric cancer across all parties has allowed us to expand our knowledge, and exchange expertise and technical skills with other experts in the field to explore and deploy testing at scale in healthcare settings.”
Built in Singapore for the world: scaling the adoption of GASTROClearTM
GASTROClearTM has been successfully commercialized in Singapore after obtaining Class C IVD certification from the HSA in September 2019. It had also obtained the CE Mark in November 2017. Furthermore, GASTROClearTM has been used as a valuable reference for the drafting and publication of miRNA molecular detection industry standards, including the SS 650: 2020 Singapore standard and ISO21474 international standard, demonstrating its outstanding clinical performance. The FDA Breakthrough Device Designation will enable Mirxes to advance and scale the adoption of GASTROClearTM globally.
Gastric cancer is associated with high mortality due to its late presentation.[ii] However, in most countries, early detection is neither feasible nor cost-effective due to high costs and the invasive nature of available screening methods that lead to poor compliance.[iii] Hence, an early detection and minimally invasive test becomes essential in improving patient outcomes.[iv] [v]
Dr. Zhou added, “The FDA Breakthrough Device Designation is designed to accelerate patient access to promising innovative technologies, and receiving the FDA Breakthrough Device Designation provides credibility to GASTROClearTM as a high impact product and opens access to international markets, increasing Mirxes’s global reach. This is an important milestone for Mirxes in charting the way forward in preventive healthcare, by shifting the way we are diagnosing cancer to substantially reduce the economic burden and improve quality of life.”
GASTROClearTM is currently available in Southeast Asia, including Singapore, Indonesia, Malaysia and Philippines.
[ii] Van Cutsem E, Sagaert X, Topal B, et al. 2016. Gastric Cancer . Lancet, 388:2654–64.
[iii] Van Cutsem E, Sagaert X, Topal B, et al. 2016. Gastric Cancer . Lancet, 388:2654–64.
[iv] Leung WK, Wu M-shiang, Kakugawa Y, et al. 2008. Screening for gastric cancer in Asia: current evidence and practice. Lancet Oncol, 9:279–87.
[v] Choi KS, Jun JK, Suh M, et al. 2015. Effect of endoscopy screening on stage at gastric cancer diagnosis: results of the National cancer screening programme in Korea. Br J Cancer, 112:608–12.
About the Breakthrough Device Designation for GASTROClear™ by U.S. FDA
GASTROClear™ was granted Breakthrough Device Designation based on the following indication for use proposed for the U.S. market.
“Mirxes GASTROClear™ Assay, is an in vitro diagnostic multiplex reverse transcription quantitative polymerase chain reaction (RT-qPCR) test intended for semi-quantitative detection of twelve (12) gastric cancer miRNA biomarkers associated with gastric cancer from human serum. The test is intended for early detection of gastric cancer in high-risk patients. The test is intended to be used prior to gastroscopy. Mirxes GASTROClear™ Assay is indicated for adults who are 40 years of age or older and who are at high risk for gastric cancer defined as having one or more of the following risk factors: diagnosed first degree relatives with gastric cancer, chronic history of Helicobacter pylori (H. pylori) infection, chronic gastritis, and intestinal metaplasia as an aid in the detection of gastric cancer. The Mirxes GASTROClear™ Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures in a laboratory setting and under the supervision of a trained laboratory professional. The Mirxes GASTROClear™ Assay is not intended for self-testing.”