為多癌種泛癌早篩領(lǐng)域帶來(lái)新突破。

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近日，由中國(guó)科學(xué)院院士、復(fù)旦大學(xué)附屬中山醫(yī)院樊嘉教授指導(dǎo)，復(fù)旦大學(xué)附屬中山醫(yī)院周儉教授、楊欣榮教授團(tuán)隊(duì)與生物科技企業(yè)鹍遠(yuǎn)生物聯(lián)合開展的研究成果在國(guó)際權(quán)威期刊《分子癌癥》（Molecular Cancer）發(fā)布，“抽一管血，完成多種癌癥早期篩查”有望實(shí)現(xiàn)。

此研究首次基于高通量測(cè)序平臺(tái)，通過(guò)創(chuàng)新設(shè)計(jì)的小型靶向甲基化測(cè)序面板，精準(zhǔn)捕獲血漿游離 DNA（cfDNA）的甲基化特征和片段組學(xué)（Fragmentomics）特征，構(gòu)建出融合深度神經(jīng)網(wǎng)絡(luò)構(gòu)架的多模態(tài)人工智能模型，實(shí)現(xiàn)對(duì)多種消化道癌癥的早期檢測(cè)與組織溯源。該技術(shù)成果標(biāo)志“中國(guó)原創(chuàng)”在癌癥早篩領(lǐng)域?qū)崿F(xiàn)從技術(shù)創(chuàng)新到臨床實(shí)證的全球性引領(lǐng)。

消化道癌癥為高發(fā)癌癥類型，占據(jù)全球癌癥新發(fā)與死亡人數(shù)的23.9%和33.2%。在中國(guó)，消化道癌癥發(fā)病率及死亡率顯著高于世界水平。針對(duì)消化道的多癌早篩較泛癌種篩查更符合中國(guó)國(guó)情，不僅能精準(zhǔn)覆蓋高發(fā)癌種，還能通過(guò)聚焦特定系統(tǒng)提升檢測(cè)效率，降低醫(yī)療資源消耗。

由于消化道癌癥存在早期癥狀隱匿的特點(diǎn)，多數(shù)患者確診時(shí)已處中晚期，導(dǎo)致預(yù)后不佳。此外，消化道疾病的良惡性鑒別仍是臨床難點(diǎn)，往往需要胃腸鏡、CT、磁共振等多項(xiàng)檢查進(jìn)行綜合判斷，進(jìn)一步阻礙了及時(shí)的檢測(cè)和干預(yù)。

基于循環(huán)腫瘤DNA的多癌種早期檢測(cè)（MCED）技術(shù)快速發(fā)展，為實(shí)現(xiàn)消化道癌癥的早期、微創(chuàng)、廣譜檢測(cè)提供了新技術(shù)路徑與臨床可能，存在巨大的市場(chǎng)潛力。

GutSeer方法專為消化道癌癥這一特定群體打造，避免納入發(fā)病率極低的癌種，更貼合中國(guó)高發(fā)癌種的疾病譜特征，有效平衡癌種覆蓋與臨床實(shí)用性，從而最大化早篩的公共衛(wèi)生價(jià)值，具有低成本、流程簡(jiǎn)便等優(yōu)勢(shì)，讓技術(shù)更貼合基層醫(yī)療與大眾篩查的成本承受能力。

根據(jù)研究成果，通過(guò)首個(gè)針對(duì)消化系統(tǒng)癌癥的前瞻性隊(duì)列研究，研究團(tuán)隊(duì)系統(tǒng)驗(yàn)證了GutSeer在消化道癌癥早期檢測(cè)中的高準(zhǔn)確性。并且，GutSeer不僅在檢測(cè)早期消化道癌癥方面表現(xiàn)出色，對(duì)高級(jí)別癌前病變亦具有良好識(shí)別能力，展示了其在特定高風(fēng)險(xiǎn)人群中的臨床應(yīng)用價(jià)值。

這一研究成果為多癌種泛癌早篩領(lǐng)域發(fā)展帶來(lái)新突破，有望改善患者的總體生存率與生活質(zhì)量，具有廣闊的臨床前景和公共衛(wèi)生意義。

據(jù)了解，鹍遠(yuǎn)生物自主開發(fā)全球首項(xiàng)大規(guī)模DNA甲基化靶向測(cè)序技術(shù)，其基于DNA甲基化的解決方案可較傳統(tǒng)方法提早四年檢測(cè)到癌癥信號(hào)，因而受關(guān)注。當(dāng)前，鹍遠(yuǎn)生物建立的產(chǎn)品組合覆蓋單癌檢測(cè)和多癌早檢，其中，GutSeer覆蓋五大高致死率消化道癌種，2024年已獲歐盟CE認(rèn)證。