CE-IVD labeled PAXgene® Blood ccfDNA tube will be available in Western Europe

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, has announced the commercial availability of the CE-IVD marked PAXgene® Blood ccfDNA tube within the European Economic Area and Switzerland (Western Europe). The plastic blood collection tube, which includes a proprietary sample stabilization additive and BD Vacutainer® Hemogard™ technology to help protect healthcare worker safety, was designed to ensure accurate and reproducible results in molecular diagnostic testing applications using circulating cell-free DNA (ccfDNA), such as cancer and non-invasive prenatal tests. The product was developed by PreAnalytiX GmbH, a joint venture between BD and QIAGEN.

Cells, including fetal cells, tumor cells, or cells from transplanted organs, release DNA into the blood stream. This DNA can be analyzed using PCR or next-generation sequencing to understand genetic characteristics of a developing fetus, a cancer tumor, or a transplanted organ from a blood draw. Molecular diagnostic tests using ccfDNA enable clinicians to gain actionable biological insights without a tissue biopsy or similar invasive test.

The PAXgene Blood ccfDNA tube provides a solution for clinical laboratories to stabilize samples when the sample cannot be processed on the same day it was collected. Where standard EDTA tubes require processing within hours before cells die and release genomic DNA into blood plasma (thus changing the native ccfDNA profile), the PAXgene tube has a unique stabilization chemistry that enables collection and processing to occur days apart, addressing a critical logistical hurdle for reference labs offering molecular testing outside of the hospital setting.

“Many molecular diagnostic companies, particularly in the cancer space, are developing new tests for monitoring and screening patients. They need a safe, clinically acceptable system for blood collection and ccfDNA processing that is capable of stabilizing a sample so that ccfDNA extraction can occur after the sample is transferred to another location, something that’s not possible with EDTA tubes,” said Frank Augello, general manager, PreAnalytiX GmbH. “This 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.”

“Reducing the potential for preanalytical errors is critical to ensuring the accuracy of molecular diagnostic tests,” said Uwe Oelmueller, Ph.D., vice president, head of MDx development sample technologies for QIAGEN, GmbH. “We are confident that the CE-IVD marked version of the PAXgene Blood ccfDNA tube will provide robust safety, and reliable and reproducible ccfDNA-based test results, helping to expand access to molecular diagnostic testing in Western Europe.”

Since 2016, PreAnalytiX has marketed a research use only (RUO) version of the PAXgene Blood ccfDNA tube together with the QIAsymphony® PAXgene® Blood ccfDNA kit as a fully integrated and standardized system covering all preanalytical workflow steps from blood collection, stabilization, transport, storage and isolation of high quality ccfDNA. The RUO tube version has the same format and stabilization chemistry as the new CE-marked version. The RUO version of the tube will be discontinued as customers adopt the CE-IVD.