Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Cancer Survival Linked to Mutational Burden in Pan-Cancer Analysis

A pan-cancer paper appearing in JCO Precision Oncology suggests tumor mutation patterns provide clues for predicting cancer survival that are independent of other prognostic factors.

Australian Survey Points to Public Support for Genetic Risk Disclosure in Relatives of At-Risk Individuals

A survey in the European Journal of Human Genetics suggests most adult Australians are in favor of finding out if a relative tests positive for a medically actionable genetic variant.

Study Links Evolution of Stony Coral Skeleton to Bicarbonate Transporter Gene

A PNAS paper focuses on a skeleton-related bicarbonate transporter gene introduced to stony coral ancestors by tandem duplication.

Hormone-Based Gene Therapy to Sterilize Domestic Cat

A new paper in Nature Communication suggests that gene therapy could be a safer alternative to spaying domestic cats.