An gane Kit ɗin Gano Ciwon Ciwon Urothelial ta FDA ta Amurka a matsayin "Na'urar Na'urar Ƙarfafawa"

Farkon Mayu 2023, TAGMe DNA Methylation Kit (qPCR) don Ciwon Urothelial Cancer wanda Shanghai Epiprobe Biotechnology Co., Ltd ya haɓaka da kansa, ya sami "Nazarin Na'urar Na'ura" daga FDA ta Amurka.

Shirin na'urorin Breakthrough na FDA na Amurka yana da nufin tabbatar da haɓaka amincewar samfuran masana'anta zuwa kasuwa a cikin ɗan gajeren lokaci, da ba marasa lafiya damar amfani da samfuran ci-gaba a baya.

Don cancanta azaman Na'urar Ƙarfafawa, dole ne a cika mahimman buƙatu guda biyu,

1, Taimakawa wajen samun ingantacciyar magani ko gano cututtuka ko yanayi masu barazana ga rayuwa ko nakasassu.

2, Cimma aƙalla ɗaya daga cikin buƙatun masu zuwa,

A, Yana wakiltar fasahar ci gaba.

B, Babu wani samfurin da aka yarda da shi.

C, Kwatanta tare da samfuran da aka yarda da su, yana da fa'idodi masu mahimmanci.

D, Amfani yana cikin mafi kyawun amfanin majiyyaci.

Nadi ba kawai yana nufin cewa Epiprobe's fasahar fasahar a farkon gano cutar kansa urothelial hukumomi sun gane shi, amma kuma ya tabbatar da babban mahimmancin asibiti da darajar zamantakewar UCOM (ciwon daji na duniya kawai alamomi) a cikin gano ciwon urothelial.Kayan aikin gano kansar urothelial kuma za su shiga cikin sauri don yin rajista, aikace-aikace da tallace-tallace a Amurka.