Singapore-based RNA technology company, Mirxes Holding Company Ltd, which specializes in blood-based miRNA test kit products, has announced that it has received Breakthrough Device Designation (BDD) from the US FDA. This prestigious award marks the first time it has been given to a gastric cancer in vitro diagnostic (IVD) product and also the first for a blood miRNA IVD product.
GASTROClea: A Pioneering Diagnostic Kit for Gastric Cancer
GASTROClea, a blood microRNA-based molecular diagnostic kit, is already approved in Singapore and the EU. The kit is currently undergoing a prospective study in China, which is set to enroll close to 10,000 subjects. This innovative product has the capability to detect gastric cancer in its early stages, and even before symptoms become apparent, addressing the critical need for precise and large-scale screening for gastric cancer.
Clinical Significance and Prospective Study
The clinical significance of GASTROClea lies in its potential to meet the demands for accurate and extensive gastric cancer screening. The ongoing study in China will further validate the product’s efficacy and safety, contributing to the global fight against gastric cancer. With the FDA’s BDD, Mirxes Holding Company is poised to accelerate the development and review process of GASTROClea, potentially bringing this life-saving technology to the market faster.-Fineline Info & Tech
