BD, Franklin Lakes, NJ, has released the CE-marked PaxGene blood circulating cell-free DNA (ccfDNA) collection tube in Western Europe. The plastic blood collection tube incorporates a proprietary sample stabilization additive and BD Vacutainer Hemogard technology to help protect healthcare worker safety, and was designed to ensure accurate and reproducible results in molecular diagnostic testing applications using ccfDNA, such as cancer and noninvasive prenatal tests.
The product was developed by PreAnalytiX GmbH, a joint venture between BD and Qiagen, Hilden, Germany.
Cells, including fetal cells, tumor cells, and cells from transplanted organs, release DNA into the blood stream. Isolated from a blood draw, such DNA can be analyzed using polymerase chain reaction or next-generation sequencing tests to understand the genetic characteristics of a developing fetus, a cancer tumor, or a transplanted organ. 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 enables clinical laboratories to stabilize samples when the sample cannot be processed on the same day it was collected. 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,” says Frank Augello, general manager at PreAnalytiX. “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 [ethylenediaminetetraacetic acid] tubes.”
“Reducing the potential for preanalytical errors is critical to ensuring the accuracy of molecular diagnostic tests,” says Uwe Oelmueller, PhD, vice president and head of molecular diagnostics development sample technologies at Qiagen. “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, including 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-marked version.