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티씨엠생명과학, 코로나19 분자진단키트 수출허가 - 바이오스펙테이터

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티씨엠생명과학, 코로나19 분자진단키트 수출허가

입력 2020-09-16 14:15 수정 2020-09-16 14:15

바이오스펙테이터 서윤석 기자

기존 키트 성능 개선한 ‘TCM-Q SARS-CoV-2 Real-time PCR kit’..2개 유전자(E, RdRP)→3개유전자(N, E, RdRP) 검출 가능

티씨엠생명과학은 신종 코로나바이러스 감염증 진단키트인 ‘TCM-Q SARS-CoV-2 Real-time PCR kit’의 식품의약품안전처 수출 허가를 받았다고 16일 밝혔다.

발표에 따르면 이 키트는 지난 4월 수출허가 받은 키트의 성능을 개선한 제품이다. 기존 두개의 튜브로 2종(E, RdRP)의 바이러스 유전자를 검출할 수 있었던 것에 비해 이번 제품은 한개의 튜브로 3종(N, E, RdRp)의 유전자를 검출할 수 있어 검사 편의성이 개선된 제품이다.

세계보건기구(WHO)는 코로나19 사태 초기에 ‘E’ 유전자와 ‘RdRp’ 유전자를 진단 기준으로 제시했으며 미국 식품의약국(FDA)는 ‘N’ 유전자를 기준으로 진단하는 것을 권고하고 있다.

티씨엠생명과학 관계자는 “이번 수출허가를 받은 진단키트는 국내외 가이드라인을 충족시키면서 적용할 수 있는 PCR 장비도 넓어진 범용성 높은 제품”이라며 “이번 신규 제품에 대한 유럽 체외진단기기(CE-IVD) 인증은 9월 내 완료할 예정”이라고 말했다. 이어 “미국 식품의약국(FDA)의 긴급사용승인도 진행할 계획”이라고 강조했다.

한편, 티씨엠생명과학은 코로나19 진단키트와 함께 여성질환용 자가진단키트(가인패드) 등을 개발한 바 있다.

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