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수젠텍, 혈액기반 결핵 현장진단키트 식약처 허가 - 바이오스펙테이터

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수젠텍, 혈액기반 결핵 현장진단키트 식약처 허가

입력 2019-07-09 11:31 수정 2019-07-09 11:31

바이오스펙테이터 장종원 기자

혈액에서 결핵균 분비하는 마커 'CFP-10' 진단..임상서 민감도 85%-특이도 96% 확보..중국 임상 진행 등 해외진출도 본격화

수젠텍이 자체 개발한 혈액기반 결핵 현장진단키트가 국내 식품의약품안전처로부터 제조허가를 획득했다. 수젠텍은 국내 허가를 위한 확증임상을 통해 민감도 85%, 특이도 96%를 확보했다

수젠텍은 지난 5일 혈액기반 결핵 진단키트 '고위험성 감염체 면역검사시약(INCLIX Blood TB)'이 식품의약품안전처 제조허가를 획득했다고 9일 밝혔다.

이 제품은 사람의 혈액에서 결핵균이 분비하는 바이오마커(CFP-10)를 측정해 결핵균의 감염여부를 현장에서 바로 진단하는 체외진단용 의료기기다.

지금까지 결핵은 의심환자에게서 객담(가래)으로 진단이 가능해 객담 추출이 어려운 노약자들은 진단이 어려웠고 객담으로 인한 감염과 오염 등으로 인해 정확하고 신속한 진단이 어려웠다.

수젠텍은 결핵을 진단하는 키트 개발을 추진해 올해 초에 국내 임상시험에서 임상성능을 확인했다. 그 결과 민감도 85%, 특이도 96%를 확보했다. 민감도는 질환이 발병했을때, 특이도는 질환이 발병하지 않았을때 이를 정확히 판별하는지를 확인하는 지표다.

수젠텍 관계자는 "기존 객담을 통한 결핵진단은 민감도가 70~90%로 불규칙할 뿐더라 생물안전 실험시설(BL2)에서 결과를 확인하다보니 오래걸리는 단점이 있었다"면서 "수젠텍은 혈액으로 의료현장에서 곧바로 진단이 가능하다는 점에서 차별화된다"고 설명했다.

수젠텍은 올해 초 정부 규제개혁 차원에서 도입된 '감염병 체외진단검사분야에 대한 선진입-후평가' 제도를 통해 우선 시장에 판매를 하면서 신의료기술평가를 진행할 계획이다.

회사는 현재 중국에서도 임상시험을 진행하고 있으며, 추가로 동남아 2개국에서의 임상시험도 추진하고 있다. 수젠텍은 올해 초 유럽 CE 인증도 획득했다. 이러한 다국가 임상을 통해 임상적 성능을 입증해 글로벌 진단시장에 도전한다는 계획이다.

손미진 수젠텍 대표는 "의료현장에서 오랜기간 동안 필요로 해 왔던 혈액 기반의 결핵 진단키트의 상용화에 성공함으로써 기존의 결핵 진단시장에 대한 대안은 물론이고 새로운 시장을 창출할 수 있게 됐다"면서 "이번 허가를 계기로 해외 시장 진출에도 속도를 낼 것"이라고 말했다.

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