NEW YORK – Chinese molecular diagnostics company Canhelp Genomics has received approval from China's National Medical Products Administration (NMPA) for its Canhelp-Origin pan-cancer test and companion analysis software.
A PCR-based tissue-of-origin assay, the Canhelp-Origin Test can measure the gene expression pattern of 90 specific markers of tissue samples and classifies 21 major tumor types that cover more than 95 percent of solid tumors by incidence, the company said. According to the NMPA database, the test, which was approved in mid-July, can be applied to formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples.
Hangzhou-based Canhelp Genomics said the Canhelp-Origin Test has been "comprehensively validated" with numerous clinical studies in collaboration with biomedical centers in China, including Beijing Cancer Hospital, Fudan University Shanghai Cancer Center, and others.
"We believe that the NMPA approval is strong proof of our mRNA-based innovations in cancer diagnostics and an important milestone in the strategy of Canhelp Genomics," said Peter Pu, Canhelp Genomics vice president, in an email.