Agilent Companion Diagnostic Assay PD-L1 IHC 28-8 pharmDx Receives European IVDR Certification

Business Wire12-11

SANTA CLARA, Calif., December 10, 2024--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) ...

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(NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) ...</p>\n\n<a href=\"https://finance.yahoo.com/news/agilent-companion-diagnostic-assay-pd-160900337.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1093756325.SGD","symbol_name":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","start_time":0,"source_url":"https://finance.yahoo.com/news/agilent-companion-diagnostic-assay-pd-160900337.html","article_id":"2490451820","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/O07RYR3AC7V1Hz8f3v2QgQ--~B/aD00MDQ7dz0xMDAwO2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/business-wire.com/e8e7491b6c04d219aa0f445eeb6bf617"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2490451820","pubTimestamp":1733846940,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"SANTA CLARA, Calif., December 10, 2024----Agilent Technologies Inc.  today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation  certification for PD-L1 IHC 28-8 pharmDx . 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PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.Agilent’s PD-L1 IHC 28-8 pharmDx  provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO  which has demonstrated therapeutic value across growing list of cancer types and OpdualagTM .Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, commented on this important achievement: \"The IVDR certification of PD-L1 IHC 28-8 pharmDx as a Class","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","LU1670710588.SGD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (SGD) ACC","LU1868837300.USD":"CT (LUX) I AMERICAN FUND \"9\" (USD) ACC","LU0237698245.USD":"富达环球地产基金A","LU1165135440.EUR":"BNP Paribas Aqua Classic Cap EUR","LU1670710661.SGD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (SGD) INC","LU2125154778.USD":"ALLSPRING GLOBAL EQUITY ENHANCED INCOME \"A\" (USD) INC","LU1169590202.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"I\" (USD) ACC","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","LU1868836914.USD":"CT (LUX) I AMERICAN \"3\" (USD) ACC","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU1670711123.USD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (USD) INC","PD":"PagerDuty, Inc.","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","LU1169589451.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"A\" (USD) ACC","GRO":"Brazil Potash Corp.","LU2041044095.USD":"Blackrock Circular Economy A2 USD","BK4156":"煤与消费用燃料","IHC":"独立控股","LU1721428933.USD":"法巴全球经典环境基金RH MD Dis","BK4581":"高盛持仓","LU1868836757.USD":"CT (LUX) I AMERICAN FUND \"2\" (USD) ACC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1032466523.USD":"高盛全球多资产收益组合Acc","LU0882574055.USD":"富达全球健康医疗A ACC","LU1670711040.USD":"M&G (LUX) GLOBAL DIVIDEND \"A\" (USD) ACC","LU0096364046.USD":"CT (LUX) I AMERICAN \"DU\" (USD) ACC","A":"安捷伦科技","BK4121":"生命科学工具和服务","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","LU1718418525.SGD":"JPMorgan Investment Funds - Global Select Equity A (acc) SGD","BK4023":"应用软件","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","LU2133065610.SGD":"JPMorgan Investment Funds - Global Dividend A (mth) SGD","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU2242646821.SGD":"Fidelity Global Dividend Plus A-MINCOME(G)-SGD","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","BK4585":"ETF&股票定投概念","BK4567":"ESG概念","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","LU2413666699.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"CRH\" (HKDHDG) INC","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","BK4007":"制药","BMY":"施贵宝","LU2092937221.SGD":"Blackrock Circular Economy A2 SGD-H","LU2413666426.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"C\" (HKD) ACC","LU2360032135.SGD":"ALLSPRING GLOBAL EQUITY ENHANCED INCOME \"A\" (SGDHDG) INC"},"translate_title":"安捷伦伴随诊断检测PD-L1 IHC 28-8 pharmDx获得欧洲IVDR认证","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PD":1,"A":1,"IHC":1,"GRO":1,"BMY":0.71},"content_text":"SANTA CLARA, Calif., December 10, 2024--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.\nAgilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO® (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and OpdualagTM (nivolumab and relatimab).\nPD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma.\nSimon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, commented on this important achievement: \"The IVDR certification of PD-L1 IHC 28-8 pharmDx as a Class C-CDx device is critical to our CDx assays and enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon.\"\nCompanion diagnostic (CDx) assays are medical devices used to help identify patients most likely to benefit from a specific drug treatment, thus offering key clinical support for the enablement of appropriate medicines. Access to IVDR-compliant CDx ensures that laboratories in the EU, who rely on Agilent products in their diagnostic workflows, can continue to use those products without disruption.\nOPDIVO® is a registered trademark of Bristol-Myers Squibb Company; OpdualagTM is a trademark of Bristol-Myers Squibb Company.\n1 Regulation (EU) 2017/746 In Vitro Diagnostic Medical Devices Regulation (europa.eu)\nAbout Agilent Technologies\nAgilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.51 billion in fiscal year 2024 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20241210429650/en/\nContacts\nMEDIA CONTACTNaomi GoumilloutAgilent Technologies+1.978.314.1862naomi.goumillout@agilent.com","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1},"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":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","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/2490451820"}