{"id":4261,"date":"2025-01-07T04:12:54","date_gmt":"2025-01-07T04:12:54","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/fda-de-novo-classification-for-its-easysep-cd138-positive-selection-kit\/"},"modified":"2025-09-29T14:00:12","modified_gmt":"2025-09-29T07:00:12","slug":"easysep-cd138-positive-selection-da-duoc-fda-phan-loai-theo-quy-trinh-de-novo-ho-tro-viec-phat-hien-va-chan-doan-ung-thu","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/easysep-cd138-positive-selection-da-duoc-fda-phan-loai-theo-quy-trinh-de-novo-ho-tro-viec-phat-hien-va-chan-doan-ung-thu\/","title":{"rendered":"EasySep\u2122 CD138 Positive Selection \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00e2n lo\u1ea1i theo quy tr\u00ecnh De Novo h\u1ed7 tr\u1ee3 vi\u1ec7c ph\u00e1t hi\u1ec7n v\u00e0 ch\u1ea9n \u0111o\u00e1n ung th\u01b0"},"content":{"rendered":"<h2 style=\"text-align:justify\"><strong>STEMCELL Technologies th\u00f4ng b\u00e1o B\u1ed9 kit EasySep\u2122 CD138 Positive Selection \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00e2n lo\u1ea1i theo quy tr\u00ecnh De Novo h\u1ed7 tr\u1ee3 vi\u1ec7c ph\u00e1t hi\u1ec7n v\u00e0 ch\u1ea9n \u0111o\u00e1n ung th\u01b0.<\/strong><\/h2>\n<p style=\"text-align:center\"><img fetchpriority=\"high\" decoding=\"async\" src=\"\" alt=\"STEMCELL Technologies Announces FDA De Novo Classification for Its EasySep\u2122 CD138 Positive Selection Kit to Support Cancer Diagnostic Tests\" width=\"322\" height=\"180\"><br \/>&nbsp;<\/p>\n<p>V\u00e0o th\u00e1ng 3 n\u0103m 2024, STEMCELL Technologies vui m\u1eebng th\u00f4ng b\u00e1o r\u1eb1ng B\u1ed9 <strong>EasySep\u2122 Human Bone Marrow CD138 Positive Selection Kit<\/strong> m\u1edbi c\u1ee7a c\u00f4ng ty \u0111\u00e3 \u0111\u01b0\u1ee3c C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA) c\u1ea5p ph\u00e2n lo\u1ea1i de novo l\u00e0 thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n in vitro (IVD) \u0111\u1ea7u ti\u00ean c\u00f3 m\u1ed9t kh\u00f4ng hai \u0111\u1ec3 l\u00e0m gi\u00e0u t\u1ebf b\u00e0o t\u1ea1o m\u00e1u.<\/p>\n<p>B\u1ed9 d\u1ee5ng c\u1ee5 n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 l\u00e0m gi\u00e0u t\u1ebf b\u00e0o plasma bi\u1ec3u hi\u1ec7n d\u1ea5u \u1ea5n \u0111\u1eb7c hi\u1ec7u CD138 (t\u1ebf b\u00e0o CD138+) t\u1eeb m\u1eabu t\u1ee7y x\u01b0\u01a1ng c\u1ee7a b\u1ec7nh nh\u00e2n. S\u1ef1 l\u00e0m gi\u00e0u \u0111\u1eb7c hi\u1ec7u theo t\u1eebng lo\u1ea1i t\u1ebf b\u00e0o nh\u01b0 v\u1eady c\u00f3 th\u1ec3 l\u00e0m t\u0103ng \u0111\u1ed9 nh\u1ea1y c\u1ee7a c\u00e1c x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n in vitro \u0111\u1ed1i v\u1edbi b\u1ec7nh \u0111a u t\u1ee7y\u2014m\u1ed9t lo\u1ea1i ung th\u01b0 c\u1ee7a t\u1ebf b\u00e0o plasma\u2014\u0111\u1ec3 cung c\u1ea5p th\u00f4ng tin t\u1ed1t h\u01a1n v\u1ec1 nguy c\u01a1 v\u00e0 qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb c\u1ee7a b\u1ec7nh nh\u00e2n.<\/p>\n<p>B\u1ec7nh \u0111a u t\u1ee7y (multiple myeloma) chi\u1ebfm 2% trong s\u1ed1 t\u1ea5t c\u1ea3 c\u00e1c lo\u1ea1i ung th\u01b0 \u1edf Hoa K\u1ef3, l\u00e0 b\u1ec7nh kh\u00f4ng th\u1ec3 ch\u1eefa kh\u1ecfi. T\u1ea7n su\u1ea5t c\u1ee7a t\u1ebf b\u00e0o CD138+ trong t\u1ee7y x\u01b0\u01a1ng th\u1ea5p v\u00e0 thay \u0111\u1ed5i nhi\u1ec1u l\u00e0m \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn \u0111\u1ed9 tin c\u1eady c\u1ee7a vi\u1ec7c ph\u00e1t hi\u1ec7n c\u00e1c b\u1ea5t th\u01b0\u1eddng v\u1ec1 gen, \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn s\u1ef1 ti\u1ebfn tri\u1ec3n c\u1ee7a b\u1ec7nh.<\/p>\n<p>Vi\u1ec7c k\u1ebft h\u1ee3p b\u1ed9 d\u1ee5ng c\u1ee5 m\u1edbi c\u1ee7a STEMCELL v\u00e0o b\u01b0\u1edbc ti\u1ec1n ph\u00e2n t\u00edch c\u1ee7a quy tr\u00ecnh ch\u1ea9n \u0111o\u00e1n c\u00f3 th\u1ec3 g\u00f3p ph\u1ea7n c\u1ea3i thi\u1ec7n k\u1ebft qu\u1ea3 b\u1eb1ng c\u00e1ch t\u0103ng c\u01b0\u1eddng \u0111\u1ed9 nh\u1ea1y v\u00e0 \u0111\u1ed9 ph\u00e2n gi\u1ea3i c\u1ee7a c\u00e1c x\u00e9t nghi\u1ec7m n\u00e0y.<\/p>\n<p>FDA x\u00e1c \u0111\u1ecbnh lo\u1ea1i s\u1ea3n ph\u1ea9m m\u1edbi n\u00e0y l\u00e0 b\u1ed9 kit l\u00e0m gi\u00e0u t\u1ebf b\u00e0o t\u1ea1o m\u00e1u: m\u1ed9t thi\u1ebft b\u1ecb ch\u1ea9n \u0111o\u00e1n lo\u1ea1i II (Clsss II IVD) d\u00f9ng \u0111\u1ec3 ch\u1ecdn l\u1ecdc c\u00e1c t\u1ebf b\u00e0o c\u1ee5 th\u1ec3 t\u1eeb <strong>m\u00e1u to\u00e0n ph\u1ea7n<\/strong> ho\u1eb7c <strong>t\u1ee7y x\u01b0\u01a1ng<\/strong> c\u1ee7a ng\u01b0\u1eddi, d\u1ef1 ki\u1ebfn s\u1eed d\u1ee5ng trong c\u00e1c x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n nh\u01b0 m\u1ed9t ph\u1ea7n c\u1ee7a quy tr\u00ecnh ti\u1ec1n ph\u00e2n t\u00edch. C\u00e1c c\u01a1 quan nh\u01b0 M\u1ea1ng l\u01b0\u1edbi Ung th\u01b0 To\u00e0n di\u1ec7n Qu\u1ed1c gia (National Comprehensive Cancer Network) v\u00e0 Tr\u01b0\u1eddng Cao \u0111\u1eb3ng Di truy\u1ec1n Y t\u1ebf Hoa K\u1ef3 (American College of Medical Genetics) khuy\u1ebfn ngh\u1ecb l\u00e0m gi\u00e0u t\u1ebf b\u00e0o CD138+ tr\u01b0\u1edbc khi th\u1ef1c hi\u1ec7n x\u00e9t nghi\u1ec7m lai hu\u1ef3nh quang t\u1ea1i ch\u1ed7 (FISH) cho b\u1ec7nh \u0111a u t\u1ee7y; tuy nhi\u00ean, cho \u0111\u1ebfn nay, c\u00e1c s\u1ea3n ph\u1ea9m l\u00e0m gi\u00e0u t\u1ebf b\u00e0o huy\u1ebft h\u1ecdc ch\u01b0a \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 thi\u1ebft b\u1ecb IVD b\u1edfi FDA.<\/p>\n<p>The EasySep\u2122 Human Bone Marrow CD138 Positive Selection Kit l\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a danh m\u1ee5c c\u00f4ng ngh\u1ec7 ph\u00e2n l\u1eadp t\u1ebf b\u00e0o mi\u1ec5n d\u1ecbch EasySepTM c\u1ee7a STEMCELL, \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n chuy\u00ean bi\u1ec7t \u0111\u1ec3 ph\u00e2n l\u1eadp nhanh ch\u00f3ng v\u00e0 d\u1ec5 d\u00e0ng c\u00e1c t\u1ebf b\u00e0o tinh khi\u1ebft cao, s\u1eb5n s\u00e0ng cho c\u00e1c \u1ee9ng d\u1ee5ng ti\u1ebfp theo. S\u1ea3n ph\u1ea9m \u0111\u00e1nh d\u1ea5u \u0111\u1ec9nh cao c\u1ee7a nhi\u1ec1u n\u0103m l\u00e0m vi\u1ec7c, bao g\u1ed3m vi\u1ec7c ki\u1ec3m tra h\u01a1n 230 d\u1ecbch h\u00fat t\u1ee7y x\u01b0\u01a1ng t\u1eeb b\u1ec7nh nh\u00e2n \u0111a u t\u1ee7y, c\u00e1c nghi\u00ean c\u1ee9u ch\u00ednh x\u00e1c v\u1ec1 kh\u1ea3 n\u0103ng t\u00e1i t\u1ea1o gi\u1eefa c\u00e1c ph\u00f2ng x\u00e9t nghi\u1ec7m v\u00e0 trong ph\u00f2ng x\u00e9t nghi\u1ec7m, c\u0169ng nh\u01b0 c\u00e1c nghi\u00ean c\u1ee9u gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n v\u00e0 can thi\u1ec7p.<\/p>\n<ul>\n<li>B\u1ed9 kit <a href=\"https:\/\/www.stemcell.com\/easysep-human-bone-marrow-cd138-positive-selection-kit-ivd.html\">EasySep\u2122 Human Bone Marrow CD138 Positive Selection Kit<\/a>&nbsp;\u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i th\u1ecb tr\u01b0\u1eddng M\u1ef9, Ch\u00e2u \u00c2u, Canada v\u00e0 Anh, v\u1edbi ch\u1ee9ng nh\u1eadn IVD lo\u1ea1i II.<\/li>\n<li>&nbsp;<a href=\"https:\/\/www.stemcell.com\/easysep-human-whole-blood-and-bone-marrow-cd138-positive-selection-kit-ii.html\">EasySep\u2122 Human Whole Blood and Bone Marrow CD138 Positive Selection Kit II<\/a>&nbsp;(Catalog #17887) \u0111\u01b0\u1ee3c b\u00e1n t\u1ea1i th\u1ecb tr\u01b0\u1eddng Vi\u1ec7t Nam v\u00e0 to\u00e0n c\u1ea7u, d\u00e1n nh\u00e3n RUO.<\/li>\n<\/ul>\n<p>&gt;&gt; Xem th\u00eam webinar v\u1ec1 ch\u1ee7 \u0111\u1ec1 ph\u00e2n l\u1eadp t\u1ebf b\u00e0o plasma cho x\u00e9t nghi\u1ec7m FISH: <a href=\"https:\/\/www.stemcell.com\/technical-resources\/plasma-cell-enrichment-prior-to-fish-testing.html\">Webinar: Plasma Cell Enrichment Prior to FISH Testing<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>STEMCELL Technologies th\u00f4ng b\u00e1o B\u1ed9 kit EasySep\u2122 CD138 Positive Selection \u0111\u00e3 \u0111\u01b0\u1ee3c FDA ph\u00e2n lo\u1ea1i theo quy tr\u00ecnh De Novo h\u1ed7 tr\u1ee3 vi\u1ec7c ph\u00e1t hi\u1ec7n v\u00e0 ch\u1ea9n \u0111o\u00e1n ung th\u01b0. &nbsp; V\u00e0o th\u00e1ng 3 n\u0103m 2024, STEMCELL Technologies vui m\u1eebng th\u00f4ng b\u00e1o r\u1eb1ng B\u1ed9 EasySep\u2122 Human Bone Marrow CD138 Positive Selection Kit m\u1edbi c\u1ee7a c\u00f4ng<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/easysep-cd138-positive-selection-da-duoc-fda-phan-loai-theo-quy-trinh-de-novo-ho-tro-viec-phat-hien-va-chan-doan-ung-thu\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":5731,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-4261","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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