''Mirxes...today announced that its flagship product, GASTROClear™, has been granted regulatory approval by China’s National Medical Products Administration (NMPA) as an in vitro diagnostic (IVD) product, becoming the first non-invasive blood test approved for the screening of gastric cancer in China.''
GASTROClear demonstrated competent diagnostic efficacy for GC in the detection of GC in our Japanese cohort, even in the early stages of cancer and asymptomatic cases. Its combination with existing serum markers may contribute to efficient risk stratification to detect GC.
"Mirxes Corporation USA, the wholly owned subsidiary of Mirxes Pte Ltd...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)."
"MiRxes said Wednesday that it has completed a Series D funding round totaling $50 million, which will help accelerate the Singapore-based firm's development of cancer early detection blood tests and other preventive healthcare solutions."
GASTROClear yielded a competent diagnostic ability for GC in the Japanese population and has a potential to contribute to efficient stratification for the risk of GCs.