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The Urothelial Cancer Detection Kit e ile ea amoheloa ke US FDA e le "Breakthrough Device Designation"

Mathoasong a May 2023, TAGMe DNA Methylation Detection Kit(qPCR) bakeng sa Kankere ea Urothelial e ikemetseng ke Shanghai Epiprobe Biotechnology Co., Ltd, e fumane "Breakthrough Device Designation" ho tsoa ho US FDA.

Lenaneo la US FDA Breakthrough Devices le ikemiselitse ho netefatsa ho khothaletsa tumello ea lihlahisoa tsa bahlahisi hore li rekisoe ka nako e khuts'oane, le ho thusa bakuli ho sebelisa lihlahisoa tse tsoetseng pele pejana.

Ho tšoaneleha ho ba Sesebelisoa sa Breakthrough, litlhoko tse peli tsa bohlokoa li tlameha ho fihleloa,

1, Aids kalafong e sebetsang haholoanyane kapa tlhahlobo ea mafu kapa maemo a sokelang bophelo kapa a fokolisang.

2, Kopana le bonyane e 'ngoe ea litlhokahalo tse latelang,

A, E emela theknoloji e tsoetseng pele.

B, Ha ho sehlahisoa se seng se lumelletsoeng.

C, Bapisa le lihlahisoa tse teng tse lumelletsoeng, e na le melemo e mengata.

D, Tšebeliso e molemong oa mokuli.

Lebitso lena ha le bolele feela hore tlhahiso ea theknoloji ea Epiprobe ea ho lemoha pele mofetše oa urothelial e lemohuoe ke ba boholong, empa hape e tiisa bohlokoa bo boholo ba kliniki le boleng ba sechaba ba UCOM (li-marker tsa kankere ea bokahohleng feela) ha ho fumanoa mofetše oa urothelial.Lisebelisoa tsa ho lemoha mofetše oa urothelial le tsona li tla kena tseleng e potlakileng ea ho ingolisa, ho etsa kopo le ho bapatsa United States.


Nako ea poso: Phup-09-2023