Ekuqaleni kukaMeyi 2023, i-TAGMe DNA Methylation Detection Kit(qPCR) ye-Urothelial Cancer eyakhiwe ngokuzimela yi-Shanghai Epiprobe Biotechnology Co., Ltd, ithole "Ukuqanjwa Kwedivayisi" ku-US FDA.
Uhlelo lwe-US FDA Breakthrough Devices Programme luhlose ukuqinisekisa ukuphromotha ukuvunyelwa kwemikhiqizo yabakhiqizi ukuthi imakethwe ngesikhathi esifushane uma kuqhathaniswa, futhi yenze iziguli zikwazi ukusebenzisa imikhiqizo ethuthukisiwe ngaphambi kwesikhathi.
Ukuze ufaneleke njenge-Breakthrough Device, izimfuneko ezimbili ezibalulekile kufanele kuhlangatshezwane nazo,
1, Ingculazi ekwelapheni okusebenzayo noma ekuxilongweni kwezifo ezisongela impilo noma eziqeda amandla noma izimo.
2, Hlangana okungenani neyodwa yalezi zidingo ezilandelayo,
A, Imele ubuchwepheshe bempumelelo.
B, Awukho omunye umkhiqizo ogunyaziwe.
C, Qhathanisa nemikhiqizo ekhona egunyaziwe, inezinzuzo ezibalulekile.
D, Ukusebenziseka kungokwentshisekelo yesiguli.
Ukuqokwa akusho nje kuphela ukuthi ukuthuthukiswa kobuchwepheshe be-Epiprobe ekutholakaleni kokuqala komdlavuza we-urothelial kuye kwaqashelwa yiziphathimandla, kodwa futhi kuqinisekisa ukubaluleka okukhulu komtholampilo kanye nenani lenhlalo le-UCOM (izimpawu zomdlavuza wendawo yonke kuphela) ekutholeni umdlavuza we-urothelial.Izinsiza zokuthola umdlavuza we-urothelial nazo zizongena emzileni osheshayo wokubhaliswa, ukufaka isicelo kanye nokumaketha e-United States.
Isikhathi sokuthumela: Jun-09-2023