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TEST:
GASTROClear Test

Company:
MiRXES
Type:
CE Marked
Evidence

News

2ms
Mirxes Announces NMPA Approval for GASTROClear™ in China, Paving the Way for Major Launch in Key Market (Mirxes Press Release)
''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.''
China approval
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GASTROClear Test
8ms
Novel and Effective Blood-Based miRNA Diagnostic Panel for Gastric Cancer: A Pilot Study in a Japanese Population. (PubMed, Cancer Med)
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.
Journal
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GASTROClear Test
over2years
Mirxes receives FDA’s Breakthrough Device Designation for GASTROClearTM to advance blood-based cancer early detection (Mirxes Press Release)
"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)."
FDA event
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GASTROClear Test
over2years
MiRxes gets $50M in Series D funding, applies to Hong Kong Limited stock exchange (Genomeweb)
"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."
Financing
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GASTROClear Test
over3years
DIAGNOSTIC PERFORMANCE OF GASTROCLEAR FOR DETECTING GASTRIC CANCER IN THE JAPANESE POPULATION (UEGW 2022)
 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.
Clinical
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CA 19-9 (Cancer antigen 19-9)
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GASTROClear Test