Ma mua o Mei 2023, TAGMe DNA Methylation Detection Kit(qPCR) no Urothelial Cancer i hoʻomohala kūʻokoʻa e Shanghai Epiprobe Biotechnology Co., Ltd, i loaʻa iā "Breakthrough Device Designation" mai US FDA.
Manaʻo ʻo US FDA Breakthrough Devices Program e hōʻoia i ka hoʻolaha ʻana i ka ʻae ʻia o nā huahana a nā mea hana e kūʻai aku i kahi manawa pōkole, a hiki i nā mea maʻi ke hoʻohana i nā huahana holomua ma mua.
No ke kūpono ʻana ma ke ʻano he Breakthrough Device, pono e hoʻokō ʻia ʻelua mau koi nui,
1, Kōkua i ka hoʻomaʻamaʻa ʻoi aku ka maikaʻi a i ʻole ka hōʻoia ʻana i nā maʻi weliweli a hoʻonāwaliwali paha.
2, E hālāwai me hoʻokahi o kēia mau koi,
A, Hōʻike i kahi ʻenehana holomua.
B, ʻAʻohe huahana ʻē aʻe i ʻāpono ʻia.
C, E hoʻohālikelike me nā huahana i ʻae ʻia, loaʻa iā ia nā pōmaikaʻi nui.
D, ʻO ka hoʻohana ʻana i ka pono o ka mea maʻi.
ʻAʻole wale ka manaʻo o ka ʻenehana ʻenehana o Epiprobe i ka ʻike mua ʻana o ka maʻi maʻi urothelial i ʻike ʻia e nā luna, akā ua hōʻoia pū i ka nui o ka clinical significance a me ka waiwai o ka UCOM (universal cancer only markers) i ka ʻike ʻana i ka maʻi maʻi urothelial.E komo pū nā pahu ʻike maʻi maʻi Urothelial i ke ala wikiwiki no ka hoʻopaʻa inoa, noi a me ke kūʻai aku ma ʻAmelika Hui Pū ʻIa.
Ka manawa hoʻouna: Jun-09-2023