We are delighted to share a major achievement for our transplant portfolio: the AlloSeq cfDNA and AlloSeq HCT assays are now IVDR-certified.
AlloSeq cfDNA is a minimally invasive, transplant-focused blood test for organ transplant surveillance. AlloSeq HCT is the latest innovation in NGS-based chimerism testing, providing a streamlined workflow and advanced sensitivity for chimerism analysis. IVDR certification reflects compliance with the European Union’s rigorous regulatory requirements for in vitro diagnostic medical devices, providing clinical laboratories with greater confidence in quality, performance, and transparency.
Beata Kmiec, Associate Director, Product Management:
” This achievement is a testament to our continued dedication to transplant patients throughout their transplant journey. IVDR certification for AlloSeq cfDNA and AlloSeq HCT is yet another confirmation of the clinical utility of these assays, enabling effective and safe graft monitoring. With the expansion of our IVDR-certified product portfolio we remain committed to exceptional quality of our transplant diagnostics solutions.”
We are proud to offer laboratory solutions that combine scientific excellence with the highest regulatory standards, helping to support better outcomes for transplant patients.
Contact our team to learn more or place an order.
AlloSeq cfDNA and AlloSeq HCT are available as CE-IVD or Research Use Only (RUO), depending on local regulatory status. RUO products are not intended for use in diagnostic procedures. For more details on local regulatory status, please contact GenDx.
AlloSeq is a trademark or registered trademark of CareDx Inc. or its subsidiaries in the US or other countries and is used under license. AlloSeq is a registered trademark with the US Patent and Trademark Office.
