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BD Gets CE Mark for Circulating Cell-Free DNA Blood-Collection Tube

NEW YORK (GenomeWeb) – Becton Dickinson said today that the PAXgene Blood ccfDNA tube has received CE-IVD marking and is commercially available within Western Europe.

PreAnalytix, a joint venture of BD and Qiagen, developed the product and designed it to ensure accurate and reproducible results in molecular diagnostic testing applications that use circulating cell-free DNA, such as cancer and non-invasive prenatal testing, BD said.

The PAXgene Blood ccfDNA tube provides a solution for clinical laboratories to stabilize samples when they cannot be processed on the day they were collected, BD said.

The tube has a stabilization chemistry that enables collection and processing to occur days apart, addressing a critical logistical hurdle for reference labs offering molecular testing outside the hospital setting, the firm added.

Frank Augello, general manager of PreAnalytix, said in a statement that the product "will help molecular diagnostics companies in Western Europe offering ccfDNA based tests to grow their markets more quickly and ultimately help more patients access leading-edge care." 

Since 2016, PreAnalytix has marketed a research-use-only version of the PAXgene Blood ccfDNA tube with Qiagen's QIAsymphony PAXgene Blood ccfDNA kit as a fully integrated system that covers all preanalytical workflow steps, including blood collection, stabilization, transport, storage, and isolation of high quality ccfDNA.

In August 2017, Qiagen and Clinical Genomics announced a partnership to use the PAXGene Blood ccfDNA Tube for collection and handling of blood samples in Clinical Genomics' Colvera colorectal cancer recurrence assay workflow.