AmoyDx wins Chi­nese ap­proval for Liq­uid Biopsy

BioSpectrum (Asia) - - Regulatory News -

The China Food and Drug Ad­min­is­tra­tion (CFDA) has ap­proved Amoy Di­ag­nos­tics’ Su­perARMS EGFR mu­ta­tion anal­y­sis test as a com­pan­ion di­ag­nos­tic for EGFR TKI-based non-small cell lung can­cer drugs. China-based AmoyDx, the real-time PCR-based test is de­signed to iden­tify EGFR mu­ta­tions in cir­cu­lat­ing tu­mor DNA in plasma sam­ples from pa­tients with ad­vanced or metastatic NSCLC. The de­vel­op­ment of liq­uid biopsy-based di­ag­nos­tics in non-small cell lung can­cer is in­tended to trans­form the di­ag­nos­tic workup of ad­vanced-stage pa­tients. The abil­ity to both iso­late and ge­net­i­cally in­ter­ro­gate tu­mor DNA from a sim­ple, min­i­mally in­va­sive test that can sub­se­quently in­form treat­ment de­ci­sions will ben­e­fit both­the physi­cian and pa­tient. In 2016, AmoyDx part­nered with Merck KGaA to de­velop a Su­perARMS-based liq­uid biopsy test for metastatic col­orec­tal can­cer for the Chi­nese mar­ket.

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