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지노믹트리, 방광암 진단키트 ‘얼리텍B’, 식약처 혁신의료기기 지정
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2024년 4월 05일
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[종양관련유전자검사시약] 이 제품은 '의료기기'이며, '사용상의 주의사항'과 '사용방법'을 잘 읽고 사용하십시오.

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코스닥 상장기업 (228760)

얼리텍® 대장암검사는 체외진단용 의료기기 EarlyTect Colon Cancer (제허 18-593호)를 사용하여, 사람 분변에서 추출한 DNA에서 신데칸-2(SDC2) 유전자의 메틸화(methylation)를 실시간 중합효소 연쇄반응(real-time PCR)으로 정성하여 대장암 진단에 보조적으로 사용하는 분자진단 검사입니다.

본 검사는 Han et al. Clinical Epigenetics, 2019;11:51 에 기술된 바와 같이 검사의 성능이 총 585명의 30~80세 사이 남녀를 대상으로 한 임상시험결과 대장암을 90.2%의 민감도와 특이도로 검사 결과가 갖는 임상적 의미가 일부 증명되었습니다. 그러나 본 검사는 임상적 유효성에 대한 추적관찰이 필요한 검사입니다.

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