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젠큐릭스 "유방암 예후진단키트로 글로벌시장 진출" - 바이오스펙테이터

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젠큐릭스 "유방암 예후진단키트로 글로벌시장 진출"

입력 2016-06-22 19:48 수정 2016-06-22 19:48

바이오스펙테이터 장은진 기자

이달말 식약처 허가 전망..내년 상반기 코스닥 상장

코넥스 상장기업 젠큐릭스가 개발한 유방암 예후진단키트의 출시가 임박했다. 유전자 분석을 통해 항암치료가 필요없는 유방암 환자를 걸러내 불필요한 치료와 고통을 줄여주는 제품이다. 젠큐릭스는 이 기술을 기반으로 내년 상반기 코스닥으로의 이전 상장도 추진한다.

젠큐릭스는 22일 서울 영등포구 한국거래소에서 기업설명회에서 "이달 말 유방암 예후진단키트의 식품의약품안전처 제조·품목허가 심사가 완료될 예정"이라면서 이 같은 계획을 밝혔다.

유방암 환자는 암을 절제하고 나서도 대부분 항암치료를 받아야 한다. 환자의 40%가량이 재발이나 전이 가능성이 낮은 저위험군 환자임에도 이를 판별하는 진단기술이 부족했기 때문이다.

젠큐릭스가 개발한 유방암 예후진단키트 '진스웰(GenesWell) BCT'는 환자의 유전자를 분석해 항암치료 여부를 가려준다.

젠큐릭스의 박응조 부장은 “유방암 예후진단키트는 환자가 가진 유전자를 분석 평가해 전이의 위험정도를 0에서 10까지 수치화한다"면서 "전이 저위험군의 환자일 경우 불필요한 항암치료을 피할 수 있고 결과적으로 보험 재정 지출도 줄일 수 있다"고 말했다.

일부 해외 업체들도 암 예후진단 서비스를 하고 있다. 하지만 해외 업체로 샘플을 전달하는 과정을 거치면 4주가량 기간이 소요되는 반면 젠큐릭스의 예후진단키트는 일주일만에 결과를 확인할 수 있다. 진단 비용 역시 350만원으로 600만원대의 해외 업체보다 저렴하다.

회사 관계자는 "신의료기술평가 등을 거쳐 제품이 출시되면 2020년까지 280억원의 이익창출이 가능할 것"이라고 설명했다.

젠큐릭스는 예후진단기술을 활용해 항암제 사용 전 효과 여부를 분석하는 동반진단키트도 개발하고 있다. 같은 항암제라도 개인의 유전적 특성에 따라 효과가 다르기 때문에 동반진단키트를 통해 환자에 특성에 맞는 항암제를 처방할 수 있도록 하는 것이다. 유방암, 폐암, 대장암 등에 적용할 수 있도록 개발 중이다.

회사 관계자는 "암을 일으키는 돌연변이 유전자에 따라 적합한 항암제를 사용하게 한다는 취지"라면서 "미국은 이미 2014년에 출시했으며 국내는 작년 10월 동반진단에 대한 가이드라인이 나온 상태"라고 말했다.

젠큐릭스는 예후진단키트의 미국 유럽 동남아 등 해외 시장 진출도 추진할 계획이라고 설명했다. 기술평가를 거쳐 내년 상반기 코스닥 상장도 추진할 계획이다.

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