Streck Cell-Free DNA BCT® Earns U.S. FDA De Novo Clearance

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September 11, 2020

Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood collection tube to be cleared for use with liquid biopsy.

“Streck is excited about this milestone for Cell-Free DNA BCT,” said Product Manager Joel Lechner. “We have always known that Cell-Free DNA BCT is the best tube for customers who are concerned about pre-analytical variation, but De Novo IVD status solidifies Cell-Free DNA BCT as a truly novel collection tube.”

Cell-Free DNA BCT was the first tube on the market focusing on cell-free DNA in plasma, more than 10 years ago. Since then, Streck has sold more than 35 million tubes worldwide, limiting preanalytical change on millions of samples for researchers around the globe. Research shows that pre-analytical variation causes up to 70% of failures in the laboratory. The tube accumulated citations in more than 100 peer-reviewed publications.

Cell-Free DNA BCT stabilizes nucleated blood cells with a unique preservative which reduces the release of cellular genomic DNA when compared to K2EDTA tubes in liquid biopsy next-generation sequencing assays. Accurate analysis of cell-free DNA can be compromised by sample handling, shipping, and processing, causing the lysis of nucleated blood cells and the subsequent release of cellular genomic DNA. By reducing the release of cellular genomic DNA, the specialized chemistry provides sample integrity. By eliminating the need for immediate plasma preparation, Cell-Free DNA BCT allows for convenient transportation from the collection site to a centralized testing location or reference laboratory for analysis.

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