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