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지노믹트리, 방광암 진단키트 ‘얼리텍B’, 식약처 혁신의료기기 지정

지노믹트리(228760)가 방광암 조기진단을 위한 체외분자진단법 ‘얼리텍-B’가 한국 식품의약품안전처로부터 혁신의료기기로 지정 받았다고 20일 밝혔다.

혁신의료기기는 기존의 의료기기나 치료법에 비해 안전성과 유효성이 현저히 개선되거나 개선될 것으로 예상되는 의료기기를 말한다. ‘얼리텍-B’는 기술적 집약도가 높고 혁신 속도가 빠른 기술이 적용되어 우선심사 대상으로 선정됐으며, 향후 제조허가 신청 시 우선적으로 심사를 받을 수 있게 됐다.

‘얼리텍-B’는 지노믹트리가 자체적으로 발굴하고 개발한 방광암 조기진단용 메틸화 바이오마커인 ‘PENK 유전자’의 검출 민감도를 개선시킨 신규 측정기술 ‘LTE-qMSP’를 통해 정확하게 검출할 수 있는 진단 기법이다. 국제 특허등록을 완료했으며, 독립적인 탐색 임상시험을 통해 잠재력을 입증한 바 있다. 또한 작년 12월에는 한국 식약처 제조 허가를 위한 대규모 다기관 전향적 확증 임상시험을 완료해 결과 보고서 작성 등의 절차를 진행 중에 있다.

방광암은 미세 혈뇨와 육안적 혈뇨증세를 나타내는 성인의 5~20%에게 발생하는데, 그 중 방광암으로 진단되는 비율은 낮다. 현재의 방광암 진단은 침습적인 방광경 검사를 통해 이루어지고 있으나 이는 매우 침습적이라 순응도가 낮은 것이 문제로 지적되고 있다.

‘얼리텍-B’는 비침습적이고 정확한 체외 진단법으로, 방광암 환자의 초기 진단과 더불어 재발 모니터링 등의 다른 사용목적에도 효과적으로 활용될 수 있다.

안성환 지노믹트리 대표는 “작년에 미국 FDA로부터 혁신의료기기로 지정 받은 ‘얼리텍-B’가 이번에 한국 식약처로부터도 혁신의료기기로 지정되어 독창성과 잠재력을 인정받았다”며 “이를 통해 방광암 환자의 삶의 질을 개선하고 총 의료비 부담을 완화하는 진단제품으로 한국 진단 시장에 빠르게 선보일 것”이라고 말했다.

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최명식

4월 17일

수고 하십니다.

‘얼리텍-B' 의 미국내에서의 1분기 매출은 어느정도 되나요?

올해 전체 매출액이 최소 300억을 예상하는데 어느정도 달성가능한가요?

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2024년 6월 25일

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2024년 6월 24일

Top Interior Designing Course in Kochi | Blitz Academy

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majan

2024년 6월 24일

The Backbone of Economic Growth: The Vital Role of Logistics

In the many-sided snare of worldwide business, planned operations remains as the uncelebrated yet truly great individual, discreetly fueling the driving force of monetary development. From the unassuming starting points of moving products from point A to point B, strategies has developed into a complex organization of interconnected frameworks that support the cutting edge economy. In the present unique world, the significance of strategies couldn't possibly be more significant, as it assumes a crucial part in driving proficiency, diminishing expenses, and working with exchange on a worldwide scale.

Coordinated operations envelops a wide range of exercises, including transportation, warehousing, stock administration, and conveyance. At its center, it is tied in with guaranteeing that products are conveyed to the perfect locations, brilliantly, and in the right condition. This might sound straightforward, yet the fact of the matter is undeniably more perplexing. In a period of without a moment to spare assembling and worldwide stock chains, the strategic difficulties are tremendous. Organizations should explore through a labyrinth of providers, transporters, customs guidelines, and international dangers to keep their tasks chugging along as expected.

One of the essential ways strategies powers monetary development is by empowering organizations to work all the more productively. By advancing inventory chains and smoothing out activities, strategies assists organizations with diminishing expenses, further develop efficiency, and upgrade their seriousness. For example, productive transportation frameworks permit firms to get to a more extensive scope of providers and markets, prompting expanded specialization and economies of scale. This, thusly, drives advancement and encourages financial turn of events.

Besides, coordinated factors assumes a urgent part in working with worldwide exchange, which is a foundation of the worldwide economy. As obstructions to exchange proceed to fall and markets become progressively interconnected, the interest for proficient coordinated factors arrangements has never been higher. Cross-line operations administrations, for example, cargo sending, customs business, and exchange finance, assume a fundamental part in working with the progression of products between nations. They assist organizations with exploring through the intricacies of global exchange guidelines, limit travel times, and decrease the expenses related with cross-line exchanges.

Besides, planned operations significantly affects financial development by setting out work open doors and driving interest in framework. The operations business utilizes a great many individuals around the world, going from transporters and distribution center specialists to store network examiners and coordinated factors chiefs. Moreover, interests in transportation framework, like streets, ports, and air terminals, work on the effectiveness of strategies tasks as well as animate financial action by interfacing districts and encouraging exchange.

In the present computerized age, innovation is changing the coordinated factors industry, opening new open doors for development and advancement. Trend setting innovations, for example, man-made brainpower, huge information investigation, blockchain, and the Web of Things (IoT) are overall progressively incorporated into coordinated factors activities, empowering more prominent perceivability, productivity, and unwavering quality. For instance, IoT sensors can give ongoing following and observing of products on the way, while prescient examination can assist with streamlining stock levels and limit inventory network disturbances.

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2024년 6월 21일

The Backbone of Economic Growth: The Vital Role of Logistics

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2024년 6월 19일

The Backbone of Economic Growth: The Vital Role of Logistics

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2024년 6월 19일

The Backbone of Economic Growth: The Vital Role of Logistics

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2024년 6월 12일

Exploring the World of Interior Design: 10 Surprising Insights

1. Historical Roots: Interior design isn't a recent phenomenon; its origins can be traced back to ancient civilizations such as Egypt, where skilled artisans crafted opulent interiors for pyramids and palaces.

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2024년 5월 25일

Oil and Gas Rig Courses in Kerala | Kochi | Bangalore

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2024년 4월 05일

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