CareDx Inc. Secures IVDR Certification for AlloSeq® Tx and QTYPE® HLA Typing Products in European Union, Reinforcing Global Transplant Diagnostics Leadership

Reuters

2025/10/06

<a href="https://laohu8.com/S/CDNA">CareDx</a> Inc. Secures IVDR Certification for AlloSeq® Tx and QTYPE® HLA Typing Products in European Union, Reinforcing Global Transplant Diagnostics Leadership

CareDx Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, has announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance with the European Union's In Vitro Diagnostic Regulation (IVDR). This regulatory milestone ensures that the products meet the highest standards for diagnostic reliability and regulatory compliance, reinforcing transparency and trust for clinical laboratories across Europe. The IVDR certification comes ahead of the EU's December 2027 deadline for HLA-typing devices. The announcement was made in conjunction with new product launches and technology previews at the 2025 American Society for Histocompatibility and Immunogenetics $(ASHI)$ Annual Meeting. No grant or funding was mentioned, and the regulatory approval pertains specifically to CareDx Inc.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CareDx Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251006088695) on October 06, 2025, and is solely responsible for the information contained therein.

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Secures IVDR Certification for AlloSeq® Tx and QTYPE® HLA Typing Products in European Union, Reinforcing Global Transplant Diagnostics Leadership\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-10-06 19:05</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/CDNA\">CareDx</a> Inc. Secures IVDR Certification for AlloSeq® Tx and QTYPE® HLA Typing Products in European Union, Reinforcing Global Transplant Diagnostics Leadership\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        CareDx Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, has announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance with the European Union's In Vitro Diagnostic Regulation (IVDR). This regulatory milestone ensures that the products meet the highest standards for diagnostic reliability and regulatory compliance, reinforcing transparency and trust for clinical laboratories across Europe. The IVDR certification comes ahead of the EU's December 2027 deadline for HLA-typing devices. The announcement was made in conjunction with new product launches and technology previews at the 2025 American Society for Histocompatibility and Immunogenetics <a href=\"https://laohu8.com/S/ASHI\">$(ASHI)$</a> Annual Meeting. No grant or funding was mentioned, and the regulatory approval pertains specifically to CareDx Inc.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CareDx Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251006088695) on October 06, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251006:nNDLbcjm1d:1","article_id":"2573667945","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2573667945","pubTimestamp":1759748714,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"CareDx Inc. 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Secures IVDR Certification for AlloSeq® Tx and QTYPE® HLA Typing Products in European Union, Reinforcing Global Transplant Diagnostics Leadership\n    \n\n        CareDx Inc. (Nasdaq: CDNA), a leader in precision medicine for transplant patients, has announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance with the European Union's In Vitro Diagnostic Regulation (IVDR). This regulatory milestone ensures that the products meet the highest standards for diagnostic reliability and regulatory compliance, reinforcing transparency and trust for clinical laboratories across Europe. The IVDR certification comes ahead of the EU's December 2027 deadline for HLA-typing devices. The announcement was made in conjunction with new product launches and technology previews at the 2025 American Society for Histocompatibility and Immunogenetics $(ASHI)$ Annual Meeting. 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