{"id":21433,"date":"2023-05-12T10:26:00","date_gmt":"2023-05-12T03:26:00","guid":{"rendered":"https:\/\/www.prnasia.com\/asia-story\/archive\/4097258_VI97258_11"},"modified":"2023-05-12T10:26:00","modified_gmt":"2023-05-12T03:26:00","slug":"invivoscribe-cong-bo-ivdr-phe-duyet-xet-nghiem-dot-bien-leukostrat-cdx-flt3","status":"publish","type":"post","link":"https:\/\/saigonbiz.com\/vn\/invivoscribe-cong-bo-ivdr-phe-duyet-xet-nghiem-dot-bien-leukostrat-cdx-flt3\/","title":{"rendered":"Invivoscribe c\u00f4ng b\u1ed1 IVDR ph\u00ea duy\u1ec7t X\u00e9t nghi\u1ec7m \u0111\u1ed9t bi\u1ebfn LeukoStrat CDx FLT3"},"content":{"rendered":"
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SAN DIEGO<\/span>, Ng\u00e0y<\/span>, 12 th\u00e1ng 5 n\u0103m 2023<\/span> \/PRNewswire\/ — “H\u00f4m nay, ch\u00fang t\u00f4i r\u1ea5t vinh d\u1ef1 \u0111\u01b0\u1ee3c th\u00f4ng b\u00e1o r\u1eb1ng X\u00e9t nghi\u1ec7m \u0110\u1ed9t bi\u1ebfn LeukoStrat\u00ae<\/sup> CDx FLT3<\/i> c\u1ee7a Invivoscribe \u0111\u00e3 \u0111\u01b0\u1ee3c BSI (H\u00e0 Lan) v\u00e0 EMA ph\u00ea duy\u1ec7t l\u00e0 x\u00e9t nghi\u1ec7m CDx Lo\u1ea1i C, \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t m\u1edbi c\u1ee7a IVDR (Quy \u0111\u1ecbnh (EU) 2017\/746). Invivoscribe l\u00e0 m\u1ed9t trong nh\u1eefng c\u00f4ng ty \u0111\u1ea7u ti\u00ean tr\u00ean th\u1ebf gi\u1edbi \u0111\u01b0\u1ee3c IVDR ph\u00ea duy\u1ec7t cho x\u00e9t nghi\u1ec7m CDx. IVDR l\u00e0 m\u1ed9t b\u1ed9 quy \u0111\u1ecbnh c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb ng\u00e0y 26 th\u00e1ng 5 n\u0103m 2022 do Li\u00ean minh Ch\u00e2u \u00c2u (EU) ban h\u00e0nh \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o an to\u00e0n, kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 hi\u1ec7u su\u1ea5t c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf ch\u1ea9n \u0111o\u00e1n trong \u1ed1ng nghi\u1ec7m (IVD)”, theo chia s\u1ebb t\u1eeb Jason Gerhold<\/span>, Gi\u00e1m \u0111\u1ed1c to\u00e0n c\u1ea7u v\u1ec1 V\u1ea5n \u0111\u1ec1 Ph\u00e1p l\u00fd, Ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 L\u00e2m s\u00e0ng t\u1ea1i Invivoscribe.<\/p>\n

IVDR \u00e1p d\u1ee5ng cho t\u1ea5t c\u1ea3 c\u00e1c IVD hi\u1ec7n c\u00f3 v\u00e0 m\u1edbi \u0111\u01b0\u1ee3c \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng \u1edf EU, bao g\u1ed3m c\u1ea3 nh\u1eefng IVD \u0111\u01b0\u1ee3c nh\u1eadp kh\u1ea9u t\u1eeb ngo\u00e0i EU. IVDR l\u00e0 m\u1ed9t h\u1ec7 th\u1ed1ng ph\u00e2n lo\u1ea1i m\u1edbi d\u00e0nh cho IVD, d\u1ef1a tr\u00ean m\u1ee9c \u0111\u1ed9 r\u1ee7i ro li\u00ean quan \u0111\u1ebfn thi\u1ebft b\u1ecb. H\u1ec7 th\u1ed1ng ph\u00e2n lo\u1ea1i \u0111\u01b0\u1ee3c chia th\u00e0nh b\u1ed1n lo\u1ea1i, Lo\u1ea1i A (r\u1ee7i ro th\u1ea5p nh\u1ea5t), Lo\u1ea1i B, Lo\u1ea1i C v\u00e0 Lo\u1ea1i D (r\u1ee7i ro cao nh\u1ea5t). Vi\u1ec7c ph\u00e2n lo\u1ea1i IVD s\u1ebd x\u00e1c \u0111\u1ecbnh m\u1ee9c \u0111\u1ed9 r\u00e0 so\u00e1t c\u1ea9n tr\u1ecdng \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng v\u1edbi thi\u1ebft b\u1ecb trong qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 t\u00ednh tu\u00e2n th\u1ee7. IVDR ph\u1ee5 thu\u1ed9c v\u00e0o c\u00e1c c\u01a1 quan ch\u1ee9ng nh\u1eadn \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n b\u1edfi EU trong qu\u00e1 tr\u00ecnh \u0111\u00e1nh gi\u00e1 v\u00e0 ch\u1ee9ng nh\u1eadn IVD. C\u00e1c c\u01a1 quan ch\u1ee9ng nh\u1eadn l\u00e0 c\u00e1c t\u1ed5 ch\u1ee9c \u0111\u1ed9c l\u1eadp \u0111\u01b0\u1ee3c EU c\u00f4ng nh\u1eadn \u0111\u1ec3 th\u1ef1c hi\u1ec7n \u0111\u00e1nh gi\u00e1 t\u00ednh tu\u00e2n th\u1ee7 v\u00e0 c\u1ea5p ch\u1ee9ng ch\u1ec9 CE.<\/p>\n

C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t IVD \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ch\u1ee9ng minh vi\u1ec7c tu\u00e2n th\u1ee7 IVDR b\u1eb1ng c\u00e1ch tri\u1ec3n khai h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 c\u00e1ch cung c\u1ea5p t\u00e0i li\u1ec7u k\u1ef9 thu\u1eadt \u0111\u1ec3 c\u1ee7ng c\u1ed1 c\u00e1c tuy\u00ean b\u1ed1 v\u1ec1 t\u00ednh tu\u00e2n th\u1ee7 c\u1ee7a h\u1ecd. H\u1ecd c\u0169ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u ch\u1ec9 \u0111\u1ecbnh m\u1ed9t c\u00e1 nh\u00e2n ch\u1ecbu tr\u00e1ch nhi\u1ec7m tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh v\u00e0 duy tr\u00ec c\u1ea9n tr\u1ecdng v\u00e0 c\u00e1c h\u1ec7 th\u1ed1ng gi\u00e1m s\u00e1t sau ti\u1ebfp th\u1ecb. C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u0169ng s\u1ebd ph\u1ea3i cung c\u1ea5p m\u1ed9t b\u1ea3n t\u00f3m t\u1eaft v\u1ec1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u su\u1ea5t l\u00e2m s\u00e0ng (SSCP) cho c\u00e1c thi\u1ebft b\u1ecb c\u1ee7a h\u1ecd, v\u00e0 b\u1ea3n t\u00f3m t\u1eaft n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng khai t\u1edbi c\u00f4ng ch\u00fang. Nh\u00ecn chung, IVDR nh\u1eb1m m\u1ee5c \u0111\u00edch t\u0103ng t\u00ednh an to\u00e0n, kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 hi\u1ec7u su\u1ea5t c\u1ee7a IVD, \u0111\u1ed3ng th\u1eddi t\u0103ng t\u00ednh \u0111\u1ea3m b\u1ea3o cho b\u1ec7nh nh\u00e2n v\u00e0 c\u00e1c chuy\u00ean gia ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe r\u1eb1ng IVD m\u00e0 h\u1ecd s\u1eed d\u1ee5ng l\u00e0 \u0111\u00e1ng tin c\u1eady v\u00e0 ch\u00ednh x\u00e1c.<\/p>\n

X\u00e9t nghi\u1ec7m \u0110\u1ed9t bi\u1ebfn LeukoStrat CDx FLT3<\/i> l\u00e0 m\u1ed9t x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n trong \u1ed1ng nghi\u1ec7m d\u1ef1a tr\u00ean PCR \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 ph\u00e1t hi\u1ec7n c\u00e1c \u0111\u1ed9t bi\u1ebfn n\u1ed1i ti\u1ebfp c\u1ee5c b\u1ed9 (ITD) v\u00e0 \u0111\u1ed9t bi\u1ebfn v\u00f9ng tyrosine kinase (TKD) D835 v\u00e0 I836 \u1edf gen FLT3<\/i> trong ADN b\u1ed9 gen \u0111\u01b0\u1ee3c chi\u1ebft xu\u1ea5t t\u1eeb nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n m\u1eafc b\u1ec7nh b\u1ea1ch c\u1ea7u c\u1ea5p t\u00ednh d\u00f2ng t\u1ee7y (AML). C\u00e1c bi\u1ebfn th\u1ec3 soma FLT3<\/i> n\u1eb1m trong s\u1ed1 c\u00e1c \u0111\u1ed9t bi\u1ebfn tr\u00ecnh \u0111i\u1ec1u khi\u1ec3n ph\u1ed5 bi\u1ebfn nh\u1ea5t v\u00ec ch\u00fang l\u00e0 m\u1ed9t trong nh\u1eefng ch\u1ec9 b\u00e1o d\u1ef1 \u0111o\u00e1n m\u1ea1nh m\u1ebd nh\u1ea5t v\u1ec1 kh\u1ea3 n\u0103ng s\u1ed1ng s\u00f3t \u0111\u1ed1i v\u1edbi b\u1ec7nh b\u1ea1ch c\u1ea7u d\u00f2ng t\u1ee7y c\u1ea5p t\u00ednh (AML)1<\/sup>, d\u1ea1ng b\u1ec7nh b\u1ea1ch c\u1ea7u nguy hi\u1ec3m nh\u1ea5t. T\u1ea1i M\u1ef9, m\u1ed7i n\u0103m c\u00f3 kho\u1ea3ng 20.000 ca b\u1ec7nh AML \u0111\u01b0\u1ee3c ch\u1ea9n \u0111o\u00e1n v\u00e0 s\u1ed1 li\u1ec7u th\u1ed1ng k\u00ea ch\u1ec9 ra r\u1eb1ng nh\u1eefng b\u1ec7nh nh\u00e2n AML m\u1edbi kh\u1edfi ph\u00e1t mang \u0111\u1ed9t bi\u1ebfn FLT3<\/i> ch\u1ec9 c\u00f3 t\u1ef7 l\u1ec7 s\u1ed1ng t\u01b0\u01a1ng \u0111\u1ed1i sau 5 n\u0103m l\u00e0 30,5%2<\/sup>.<\/p>\n

“B\u1eb1ng vi\u1ec7c tr\u1edf th\u00e0nh m\u1ed9t trong nh\u1eefng CDx \u0111\u1ea7u ti\u00ean \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t theo IVDR, Invivoscribe m\u1ed9t l\u1ea7n n\u1eefa kh\u1eb3ng \u0111\u1ecbnh v\u1ecb th\u1ebf d\u1eabn \u0111\u1ea7u c\u1ee7a m\u00ecnh, th\u00e1i \u0111\u1ed9 t\u1eadp trung c\u1ee7a ch\u00fang t\u00f4i v\u00e0o vi\u1ec7c tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh, c\u0169ng nh\u01b0 c\u00e1ch ch\u00fang t\u00f4i ch\u00fa tr\u1ecdng v\u1ec1 t\u1ea7m quan tr\u1ecdng c\u1ee7a ti\u00eau chu\u1ea9n h\u00f3a qu\u1ed1c t\u1ebf \u0111\u1ed1i v\u1edbi c\u00e1c x\u00e9t nghi\u1ec7m ch\u1ea9n \u0111o\u00e1n ph\u00e2n t\u1eed. Ch\u00fang t\u00f4i tin r\u1eb1ng vi\u1ec7c tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n nghi\u00eam ng\u1eb7t v\u00e0 th\u1ef1c h\u00e0nh trong ph\u00f2ng th\u00ed nghi\u1ec7m l\u00e0 m\u1ed9t v\u00ed d\u1ee5 v\u1ec1 gi\u00e1 tr\u1ecb t\u00edch h\u1ee3p d\u1ecdc c\u1ee7a c\u00f4ng ty tr\u1edf n\u00ean r\u00f5 r\u00e0ng,” Jeff Miller<\/span>, T\u1ed5ng gi\u00e1m \u0111\u1ed1c ki\u00eam Gi\u00e1m \u0111\u1ed1c kinh doanh c\u1ee7a Invivoscribe cho bi\u1ebft. “V\u1edbi \u0111\u1ed9i ng\u0169 to\u00e0n c\u1ea7u t\u00e0i n\u0103ng, chuy\u00ean m\u00f4n v\u1ec1 R&D, tin sinh h\u1ecdc v\u00e0 AI, s\u1ea3n xu\u1ea5t cGMP, quy \u0111\u1ecbnh, ch\u1ea5t l\u01b0\u1ee3ng, c\u00e1c v\u1ea5n \u0111\u1ec1 l\u00e2m s\u00e0ng, b\u00e1n h\u00e0ng, ti\u1ebfp th\u1ecb v\u00e0 hi\u1ec7u su\u1ea5t c\u1ee7a c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m l\u00e2m s\u00e0ng tr\u00ean kh\u1eafp th\u1ebf gi\u1edbi, Invivoscribe c\u00f3 v\u1ecb th\u1ebf thu\u1eadn l\u1ee3i \u0111\u1ec3 ph\u1ee5c v\u1ee5 nhu c\u1ea7u ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe c\u00e1c nh\u00e0 cung c\u1ea5p, v\u00e0 c\u00e1c \u0111\u1ed1i t\u00e1c d\u01b0\u1ee3c ph\u1ea9m v\u00e0 sinh h\u1ecdc to\u00e0n c\u1ea7u c\u0169ng nh\u01b0 khu v\u1ef1c”.<\/p>\n

Gi\u1edbi thi\u1ec7u v\u1ec1 Invivoscribe
<\/b>Invivoscribe l\u00e0 c\u00f4ng ty c\u00f4ng ngh\u1ec7 sinh h\u1ecdc to\u00e0n c\u1ea7u, t\u00edch h\u1ee3p theo chi\u1ec1u d\u1ecdc chuy\u00ean c\u1ea3i thi\u1ec7n cu\u1ed9c s\u1ed1ng b\u1eb1ng Precision Diagnostics\u00ae<\/sup>. Trong g\u1ea7n 30 n\u0103m qua, Invivoscribe \u0111\u00e3 c\u1ea3i thi\u1ec7n ch\u1ea5t l\u01b0\u1ee3ng ch\u0103m s\u00f3c s\u1ee9c kh\u1ecfe tr\u00ean to\u00e0n th\u1ebf gi\u1edbi b\u1eb1ng c\u00e1ch cung c\u1ea5p thu\u1ed1c th\u1eed, x\u00e9t nghi\u1ec7m v\u00e0 c\u00f4ng c\u1ee5 tin sinh h\u1ecdc \u0111\u01b0\u1ee3c ti\u00eau chu\u1ea9n h\u00f3a ch\u1ea5t l\u01b0\u1ee3ng cao nh\u1eb1m n\u00e2ng cao t\u00ednh ch\u00ednh x\u00e1c trong y h\u1ecdc. Invivoscribe c\u00f3 th\u00e0nh t\u00edch h\u1ee3p t\u00e1c th\u00e0nh c\u00f4ng v\u1edbi c\u00e1c c\u00f4ng ty d\u01b0\u1ee3c ph\u1ea9m to\u00e0n c\u1ea7u quan t\u00e2m \u0111\u1ebfn vi\u1ec7c ph\u00e1t tri\u1ec3n v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a ch\u1ea9n \u0111o\u00e1n \u0111\u1ed3ng h\u00e0nh, \u0111\u1ed3ng th\u1eddi cung c\u1ea5p ki\u1ebfn th\u1ee9c chuy\u00ean m\u00f4n trong c\u1ea3 d\u1ecbch v\u1ee5 qu\u1ea3n l\u00fd v\u00e0 ph\u00f2ng th\u00ed nghi\u1ec7m. Cung c\u1ea5p c\u00e1c b\u1ed9 c\u00f4ng c\u1ee5 c\u00f3 th\u1ec3 ph\u00e2n ph\u1ed1i, c\u00e1c d\u1ecbch v\u1ee5 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng th\u00f4ng qua c\u00e1c chi nh\u00e1nh ph\u00f2ng th\u00ed nghi\u1ec7m l\u00e2m s\u00e0ng (LabPMM) c\u00f3 tr\u1ee5 s\u1edf tr\u00ean to\u00e0n c\u1ea7u, Invivoscribe l\u00e0 \u0111\u1ed1i t\u00e1c l\u00fd t\u01b0\u1edfng t\u1eeb ph\u00e1t tri\u1ec3n ch\u1ea9n \u0111o\u00e1n, \u0111\u1ebfn c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, \u0111\u1ec7 tr\u00ecnh quy \u0111\u1ecbnh v\u00e0 th\u01b0\u01a1ng m\u1ea1i h\u00f3a. \u0110\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin, vui l\u00f2ng li\u00ean h\u1ec7 v\u1edbi Invivoscribe t\u1ea1i: inquiry@invivoscribe.com<\/a> ho\u1eb7c theo d\u00f5i Invivoscribe tr\u00ean LinkedIn<\/a>.<\/p>\n

Tham kh\u1ea3o: 
1. Daver N v\u00e0 C\u1ed9ng s\u1ef1 B\u1ec7nh b\u1ea1ch c\u1ea7u<\/i> (2019) 33:299-312.
2. https:\/\/seer.cancer.gov\/statfacts\/html\/amyl.html<\/a><\/p>\n

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ngu\u1ed3n: Invivoscribe, Inc.<\/p>\n","protected":false},"excerpt":{"rendered":"

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