FDA核准罗氏与礼来pTau217血液检测，同一阈值同时用于纳入和排除淀粉样病理

环球市场播报08-25

美国食品药品管理局周一（8月24日）核准罗氏与礼来合作开发的Elecsys Phospho-Tau（217P）血浆检测（pTau217）。该检测面向55岁及以上、已出现认知下降体征、症状或主诉的人群，用于辅助判断是否存在与阿尔茨海默病相关的淀粉样病理。检测结果分阳性、中间、阴性三类，须与其他临床信息一并解读，不能单独作为诊断。价格尚未公布。　　罗氏称，这是目前唯一获FDA核准、仅用单一生物...

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href=https://finance.sina.com.cn/stock/usstock/c/2026-08-25/doc-inipqaan2250115.shtml><strong>环球市场播报</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>美国食品药品管理局周一（8月24日）核准罗氏与礼来合作开发的Elecsys Phospho-Tau（217P）血浆检测（pTau217）。该检测面向55岁及以上、已出现认知下降体征、症状或主诉的人群，用于辅助判断是否存在与阿尔茨海默病相关的淀粉样病理。检测结果分阳性、中间、阴性三类，须与其他临床信息一并解读，不能单独作为诊断。价格尚未公布。\n\n　　罗氏称，这是目前唯一获FDA核准、仅用单一生物...</p>\n\n<a href=\"https://finance.sina.com.cn/stock/usstock/c/2026-08-25/doc-inipqaan2250115.shtml\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0354030511.USD","symbol_name":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) 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AMERICAN GROWTH PORTFOLIO \"AD\" (HKD) INC"},"translate_title":"FDA approves Roche and Eli Lilly pTau217 blood tests with the same threshold for inclusion and exclusion of amyloid pathology","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LLII":0.6,"TMED":0.6,"FHLC":0.6,"ELIL":0.6,"OZEM":0.6,"IHE":0.6,"MEDI":0.6,"IYH":0.6,"LLYZ":0.6,"MHIP":0.6,"LLY":1.9,"LLYX":0.6,"FTXH":0.6,"RHHBY":1.94,"AGNG":0.6,"JDOC":0.6,"XLV":0.6,"TRUH":0.6,"PPH":0.6,"ILDR":0.6,"03165":0.6,"CURE":0.6,"HRTS":0.6,"ELIS":0.6,"MEDX":0.6,"PJP":0.6,"WDNA":0.6,"GDOC":0.6,"RXL":0.6,"CANC":0.6,"IXJ":0.6,"THNR":0.6,"VHT":0.6},"content_text":"美国食品药品管理局周一（8月24日）核准罗氏与礼来合作开发的Elecsys Phospho-Tau（217P）血浆检测（pTau217）。该检测面向55岁及以上、已出现认知下降体征、症状或主诉的人群，用于辅助判断是否存在与阿尔茨海默病相关的淀粉样病理。检测结果分阳性、中间、阴性三类，须与其他临床信息一并解读，不能单独作为诊断。价格尚未公布。\n\n　　罗氏称，这是目前唯一获FDA核准、仅用单一生物标志物、并在基层与专科使用同一套已验证临界值、同时支持“纳入”和“排除”淀粉样病理评估的血液检测。检测在血浆中测定磷酸化tau 217。水平高，提示淀粉样病理更可能存在；水平低，提示更可能不存在。中间结果需进一步评估。\n　　罗氏诊断北美总裁兼首席执行官丹·马拉雷克说，核准使评估可以更靠近患者就诊的第一线。礼来神经科学总裁卡罗尔·霍说，合作目标是把同一项检测同时送进基层（多数认知主诉首先出现的地方）和专科。\n　　适用对象与不能做的事已写进标签\n　　适应证限定为55岁及以上、已有认知下降相关表现的人。罗氏写明：安全性和有效性尚未建立用于预测痴呆或其他神经疾病的发生，也未建立用于监测治疗产品效果。结果必须结合其他诊断工具和临床信息。\n　　佛罗里达神经退行性疾病研究所研究主任理查德·艾萨克森对CNN表示，阴性预测值足够，阳性预测值并不理想；假阳性、中间分类，以及样本处理和肾病、病毒感染等情况，都会增加解读难度。他主张用一组检测，而不是单一“阿尔茨海默病血液检测”。\n　　传统确认淀粉样病理的方法是PET显像或脑脊液检测，费用高、侵入性强，专科中心以外不易获得。罗氏引用的国际阿尔茨海默病协会材料写，全球约75%的痴呆患者仍未得到诊断；从症状出现到确诊，常见要等约3.5年。\n　　现有4500台cobas设备可直接跑，Quest计划四季度上线\n　　检测设计在美国已安装的超过4500台罗氏cobas实验室仪器上运行，实验室不必另购设备。罗氏称评估显示，在55岁及以上、有认知下降相关主诉的人群中，该检测与淀粉样PET显像高度一致。具体灵敏度、特异度数字未在本次新闻稿中单列。\n　　Labcorp和Quest Diagnostics周一表示将通过各自网络提供该项检测。Quest称，将在2026年第四季度向全美医生和临床试验合作方推出以AD-Detect为品牌、基于该FDA核准试剂的实验室服务，并计划在2027年把该试剂纳入后续组合检测。Quest同时宣布将于本月底推出自有多标志物实验室自建检测，不在本次FDA核准范围内。\n　　该检测今年5月获得欧洲CE标志，上月已在欧洲上市。罗氏未公布美国定价。\n　　这是同类血液检测中的第四项FDA核准\n　　2025年5月，富士瑞必欧的Lumipulse成为FDA核准的首个用于辅助评估阿尔茨海默病的血液检测。同年10月，罗氏与礼来的Elecsys pTau181获准，主要用于基层排除淀粉样病理。上周，C2N Diagnostics的PrecivityAD2获准，适用年龄可低至40岁。pTau217与pTau181测定的是不同磷酸化位点。\n　　印第安纳大学健康神经科医生贾里德·布罗施说，PET和脑脊液可以确认淀粉样病理，但成本高、侵入性强，许多患者难以获得；血液标志物把评估扩展到更多诊疗场景。罗氏在研管线还包括脑内递送的淀粉样抗体trontinemab（两项III期）和口服γ分泌酶调节剂nivegacetor（II期）。这些药物与本次检测核准是分开的事项。\n　　检测已获准进入美国现有实验室流程。Quest的品牌服务计划在2026年第四季度向医生开放。价格、保险报销路径以及中间结果在日常门诊中如何处置，公司尚未给出时间表。\n\n罗氏cobas实验室分析系统。公司称美国已装机超过4500台，pTau217可在现有流程中运行。\n\n　　礼来与罗氏的合作把同一试剂同时对准基层和专科。中间结果如何转诊、阳性之后是否直接进入抗淀粉样治疗评估，仍取决于各医疗机构自己的路径，不在本次标签范围内。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.52.0","shortVersion":"4.52.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2662758191","isCrawlerRequest":true}