Product aimed at cancer and non-invasive prenatal testing applications
BD has announced the commercial availability of the CE-IVD marked PAXgene Blood ccfDNA tube within European.
The plastic blood collection tube, which includes a proprietary sample stabilisation 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, a joint venture between BD and QIAGEN.
Cells, including foetal cells, tumour cells, or cells from transplanted organs, release DNA into the blood stream. This can be analysed using PCR or next-generation sequencing to understand genetic characteristics of a developing foetus, a cancer tumour, 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 stabilise samples when the sample cannot be processed on the same day it was collected.
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
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 stabilisation 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,” said Frank Augello, general manager at PreAnalytiX.
“They need a safe, clinically-acceptable system for blood collection and ccfDNA processing that is capable of stabilising a sample so that ccfDNA extraction can occur after the sample is transferred to another location, something that’s not possible with EDTA tubes.
“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 pre-analytical errors is critical to ensuring the accuracy of molecular diagnostic tests,” added Uwe Oelmueller, vice president and head of MDx 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.”