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348 Warning: mysql_real_escape_string(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_real_escape_string(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 30 Warning: mysql_query(): Access denied for user 'et1ssh96'@'localhost' (using password: NO) in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_query(): A link to the server could not be established in /service/web/biospcmbl/comlib/dblib.php on line 530 Warning: mysql_fetch_array() expects parameter 1 to be resource, boolean given in /service/web/biospcmbl/comlib/dblib.php on line 531 소피아제네틱스, NGS 혈액암 검사 ‘유럽 CE-IVD' 획득 - 바이오스펙테이터

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소피아제네틱스, NGS 혈액암 검사 ‘유럽 CE-IVD' 획득

입력 2018-02-09 06:45 수정 2018-02-09 08:21

바이오스펙테이터 이은아 기자

세계최초 capture base NGS 방식으로 인증, 혈액암 관련 유전자 30개 검출가능, 정확도 99%

스위스 유전체분석회사 소피아제네틱스(Sophia Genetics)가 NGS 기반 혈액암 패널인 'Myeloid Solution'의 유럽 체외진단의료기기 인증(CE-IVD)을 획득했다고 지난 6일 밝혔다.

Myeloid Solution은 골수 및 림프성백혈병을 일으키는 돌연변이를 탐지하기 위해 capture 방식으로 원하는 유전자 부위만 잡아서 시퀀싱하는 capture-base NGS 혈앰암 패널이다. 이는 불필요한 유전자 부분도 증폭해 오류를 범할 수 있는 기존의 amplicon 기반 PCR 방식의 한계점을 극복한 방법이다.

CE-IVD는 유럽 시장에 진출하기 위한 모든 체외진단용 의료기기가 품질 적합성을 입증하기 위해 의무적으로 획득해야만 하는 인증이다. 이번 CE-IVD 인증은 capture-base NGS 방식으로는 세계 최초라는 게 회사 측의 설명이다. 키트 뿐만 아니라 단일염기다형성(SNP), 인델(indel), 유전자복제수변이(CNV)를 검출하는 알고리즘도 CE-IVD 인증에 포함된다.

Myeloid Solution은 혈액암과 관련된 30개의 유전자를 검출한다. 특히 GC base pair가 많은 부위에서도 유전자를 정확히 읽을 수 있기 때문에 CEBPA, FLT3, CALR 유전자와 같은 대표적인 혈액암 돌연변이도 정확히 검출할 수 있다.

소피아제네틱스 측은 “Myeloid Solution는 99%에 달하는 특이도, 민감도, 정확도, 재현성을 가진다. 이를 통해 바이오마커 기반 약물탐색과 개인 맞춤형 암치료에 지원할 것이다”고 밝혔다.

2011년 설립된 소피아제네틱스는 AI기반 진단 플랫폼을 개발하기 위해 지난 9월 3000만달러 규모의 시리즈D 펀딩에 성공했다. 현재 55개국 400개 병원에서 소피아가 자체 개발한 유전체 해석 솔루션을 도입해 약 17만 명의 환자샘플을 분석했으며, 오는 2020년까지 환자 100만명의 샘플 분석을 목표로 의료기관의 임상데이터와 유전자변형 검사를 이용해 AI기반 진단 플랫폼을 개발하고 있다.

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