I-Urothelial Cancer Detection Kit yamkelwa yi-US FDA “njengeSixhobo sokuLawulwa”

Ebutsheni bukaMeyi ka-2023, i-TAGMe DNA Methylation Detection Kit(qPCR) ye-Urothelial Cancer ephuhliswe ngokuzimeleyo yi-Shanghai Epiprobe Biotechnology Co., Ltd, ifumene “Ukutyunjwa kwesiXhobo esiNgqongileyo” kwi-US FDA.

INkqubo yeZixhobo zokuPhumelela kwe-FDA ijolise ekuqinisekiseni ukukhuthaza ukuvunywa kweemveliso zabavelisi ukuthengisa ngexesha elifutshane, kwaye yenza ukuba izigulana zisebenzise iimveliso eziphambili kwangaphambili.

Ukuze ufaneleke njengesixhobo sokuPhumelela, iimfuno ezimbini eziphambili kufuneka zifezekiswe,

I-1, i-Aids kunyango olusebenzayo ngakumbi okanye ukuxilongwa kwezifo ezisongela ubomi okanye eziphazamisayo okanye iimeko.

2, Hlangana ubuncinane enye yezi mfuno zilandelayo,

A, Imele iteknoloji yempumelelo.

B, Ayikho enye imveliso evunyiweyo.

C, Thelekisa iimveliso ezivunyiweyo ezikhoyo, ineenzuzo ezibalulekileyo.

D, Ukusebenziseka ngowona mdla wesigulane.

Ukutyunjwa akuthethi nje ukuba i-Epiprobe ye-teknoloji entsha ekubonweni kwangaphambili komhlaza we-urothelial iye yaqatshelwa ngabasemagunyeni, kodwa iphinda iqinisekise ukubaluleka kweklinikhi enkulu kunye nexabiso lentlalontle ye-UCOM (i-universal cancer markers kuphela) ekufumaneni umhlaza we-urothelial.Iikiti zokufumanisa umhlaza we-Urothelial nazo ziya kungena kwindlela ekhawulezayo yokubhalisa, ukufaka isicelo kunye nokuthengisa e-United States.