The Urothelial Cancer Detection Kit idadziwika ndi US FDA ngati "Breakthrough Device Designation"

Kumayambiriro kwa Meyi 2023, TAGMe DNA Methylation Detection Kit(qPCR) ya Urothelial Cancer yopangidwa ndi Shanghai Epiprobe Biotechnology Co., Ltd, idalandira "Breakthrough Device Designation" kuchokera ku US FDA.

US FDA Breakthrough Devices Program ikufuna kuwonetsetsa kuvomereza kwa zinthu zopangidwa ndi opanga kuti azigulitsa pakanthawi kochepa, ndikupangitsa odwala kugwiritsa ntchito zinthu zapamwamba kale.

Kuti muyenerere kukhala Chida cha Breakthrough, zofunika ziwiri ziyenera kukwaniritsidwa,

1, Kuthandizira chithandizo chamankhwala chogwira mtima kwambiri kapena kuzindikira matenda owopsa kapena ofooketsa kapena mikhalidwe.

2, Kukwaniritsa chimodzi mwazofunikira izi,

A, Ikuyimira ukadaulo wopambana.

B, Palibe mankhwala ena ovomerezeka.

C, Yerekezerani ndi zomwe zilipo kale zovomerezeka, zili ndi ubwino waukulu.

D, Kugwiritsa ntchito ndikoyenera kwa wodwala.

Kutchulidwaku sikumangotanthauza kuti luso laukadaulo la Epiprobe pakuzindikira koyambirira kwa khansa ya mkodzo wadziwika ndi akuluakulu aboma, komanso amatsimikizira kufunika kwachipatala komanso kufunika kwa chikhalidwe cha UCOM (zolemba za khansa yapadziko lonse) pozindikira khansa ya mkodzo.Zida zodziwira khansa ya urothelial zidzalowanso njira yofulumira yolembetsa, kugwiritsa ntchito komanso kutsatsa ku United States.