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Warning: mysql_real_escape_string(): Access denied for user 'apache'@'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 'apache'@'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 바이오니아 'HIV-1 키트' 글로벌펀드 구매리스트 등재 - 바이오스펙테이터

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바이오니아 'HIV-1 키트' 글로벌펀드 구매리스트 등재

입력 2019-02-08 12:59 수정 2019-02-08 12:59

바이오스펙테이터 장종원 기자

국내 식약처 허가도 동시 획득..글로벌 시장 진출 본격화

바이오니아가 개발한 HIV-1 정량분석키트가 국내 시판 허가와 함께 글로벌펀드 구매리스트에 등재됐다.

바이오니아는 지난 1월말 에이즈 환자 치료관리에 사용되는 HIV-1 바이러스 정량분석키트 'AccuPower HIV-1 Quantitative RT-PCR Kit'의 식품의약품안전처 허가를 받았다고 8일 밝혔다.

같은 시기 HIV-1 정량 분석 키트와 함께 분자진단시스템 ‘ExiStation'이 글로벌펀드(The Global Fund to Fight AIDS, Tuberculosis and Malaria) 구매리스트에 등재됐다. HIV-1 정량 분석 키트의 글로벌펀드 구매리스트 등록은 국내 기업 중 최초라는게 회사측의 설명이다.

이번 글로벌펀드 등록으로 바이오니아 제품이 전세계 에이즈 환자들에게 사용될 수 있는 길이 열렸다.

글로벌펀드는 에이즈, 결핵, 말라리아 퇴치를 위해 설립된 비영리 재단으로 전세계 주요 에이즈 퇴치 자금 조달 기관 중 하나다. 2002년 설립 후 150여개국 대상 3대 질병 관련 프로그램에 약 390억 달러 규모의 기금을 집행했다. 구매리스트는 엄격한 규제 심사와 테스트, 전문 심사위원회의 검토를 거친 제품에 한해 등록이 가능하다.

전세계 HIV 진단시장 규모는 2016년 23억5000만달러에서 2021년 38억8000만달러로 확대될 전망이다. WHO 권고사항에 따르면 에이즈 환자들은 HIV 항바이러스제를 통한 치료 후 경과 확인을 위해 연간 2회 이상 혈액 내 HIV-1 바이러스 검사가 필요하다.

바이오니아의 HIV-1 정량분석 키트는 지난해 10월 유럽 체외진단시약 인증을 완료했고 현재 WHO PQ(Prequalification, 사전적격인증) 신청을 진행하고 있으며, 기타 국제원조기구들의 공공입찰 시장에도 참여하고 있다.

또한 국내 식약처 허가 획득으로 국내뿐만 아니라 베트남을 비롯해 태국, 인도네시아 등 동남아시아 국가에 상반기 출시를 위한 협의를 진행 중이다.

바이오니아 관계자는 "바이오니아의 특허기술들을 이용해 원재료부터 장비까지 자체 개발·생산한 분자진단 제품들이 해외에서도 품질을 인정받고 있다”며 “글로벌 기업들의 제품에 비해 가격 경쟁력이 있어서 국내는 물론 세계 에이즈 진단시장에서 경쟁력을 갖추고 있다”고 말했다.

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