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.
That is largely my biggest complaint with BnS NEO Divine Gems, outside of NCSOFT’s continued issue with bots and gold sellers on their servers. This isn’t unique to Blade and Soul Neo, as it’s also a persistent issue with Throne and Liberty, and was at one point so infamous in Lineage II that it was even reported on in GameInformer in the mid-00’s.
This problem has followed NCSOFT through its multiple new releases, and is still one in Blade and Soul Neo. General and Trade chats are drowned out by gold sellers, bots populate areas, interfering with the idea of existing with others in a shared digital space. At the very least, I can say that this was true to the launch experience of Blade and Soul in North America and Europe. Which I have a Founder’s Pack of, thanks to my partner, who at one point let me use his Chinese ID to register for a QQ account and play in 2014 after it was released in that region. (As you can probably tell, I was really into Blade and Soul. At the very least, the idea of it.)
Blade and Soul Neo is more or less the starting experience veteran players would have had on release. There are only a handful of classes, each limited to specific races the Gon, Jin, Yun, and Lyn, each based on the Four Guardians in Chinese folklore. I wouldn’t say any race has any specific advantage, outside of what classes they have access to. This impacts your cosmetics above anything else, and how little clothing you want to wear.
My first foray had me playing a Jin, and I genuinely loved dressing her up. The character creator in Blade and Soul still remains a head above the rest, and hasn’t changed in Neo. You can change the broadness of your shoulders, the size of your feet, hands, and because the game relies on sex appeal, even the breasts of your character. It’s a game that boasts designs from Korean concept artist and studio lead Hyung-tae Kim of MagnaCarta, now Stellar Blade, fame. This isn’t a knock against the game. It knows what it wants to be, and I applaud it for sticking to its guns. Sometimes you want to be sexy and kick ass, and Blade and Soul has always fulfilled this fantasy.
However, this time I opted for a Gon this time, shrinking him down in the expansive character to creator, to not be an absolute mammoth of a man as I slung around projectiles made of ice and fire, alternating to keep up status effects as a Forcemaster. However, I did end up remaking the character I played cheap BnS Classic Divine Gems in the original Blade and Soul, a Jin Kung-Fu Master. She excelled in hand-to-hand combat, and I loved making use of perfect blocks to deal damage back to enemies, and even counter attacks at later levels. The dynamic action of that class continued to call to me, and in the end I abandoned my Forcemaster (which is Blade and Soul’s caster) for the raw damage my fists provided.