Cell-Free DNA BCT®

Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization and transport of venous whole blood samples for use in conjunction with cell-free DNA next generation sequencing assays that have been cleared or approved for use with samples collected into the Cell-Free DNA BCT device.

Performance characteristics of Cell-Free DNA BCT have been established on the Guardant360 CDx assay and Guardant Shield assay. Laboratories should verify that their specific NGS assay has been cleared or approved for use with samples collected in Cell-Free DNA BCT before implementing this collection device. If their assay has not been cleared or approved for use with samples collected in Cell-Free DNA BCT, they should use of the CE/RUO version of the product.

Cell-Free DNA BCT stabilizes cell-free DNA for up to 7 days. This extended stability eliminates the need for immediate plasma isolation and allows for room temperature storage and shipping, reducing pre-analytical variation that can occur during sample handling and transport.

No, Cell-Free DNA BCT allows for cold chain-free transport at room temperature. This simplifies logistics, reduces shipping costs and makes it easier to collect samples at remote or off-site locations without requiring specialized shipping arrangements or immediate processing.

Room temperature stabilization eliminates the need for immediate plasma separation and cold chain shipping, which are major logistical challenges for cell-free DNA testing. Without stabilization, blood cells can lyse during transport, releasing contaminating genomic DNA that dilutes the cell-free DNA signal and compromises test accuracy. Cell-Free DNA BCT solves this by maintaining sample integrity for up to 7 days at room temperature, enabling reliable testing even when samples must be shipped from remote locations.

Pre-analytical variation refers to changes that occur in blood samples during collection, handling, transport and storage before laboratory testing. For cell-free DNA analysis, the most critical pre-analytical variable is cell lysis, which releases genomic DNA from white blood cells and dilutes the cell-free DNA targets. Cell-Free DNA BCT prevents cell lysis and stabilizes samples, ensuring that test results reflect the patient’s true biological state rather than artifacts introduced during sample processing.