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Streck Gets FDA De Novo Clearance for Blood Collection Tube With Guardant Health Liquid Biopsy Assay

NEW YORK ─ Streck said on Friday that the US Food and Drug Administration has granted de novo clearance for use of its Cell-Free DNA BCT blood collection tube with the Guardant Health Guardant360 CDx liquid-biopsy companion-diagnostic assay.

Cell-Free DNA BCT is the first circulating nucleic acid blood collection tube to be cleared for use with liquid biopsy, Streck said.

Its blood collection tube stabilizes nucleated blood cells with a preservative that reduces the release of cellular genomic DNA compared to the use of K2EDTA tubes in liquid biopsy-based next-generation sequencing assays, the firm said. By reducing the release of cellular genomic DNA, Cell-Free DNA BCT's specialized chemistry maintains native cell-free DNA populations and provides sample integrity, La Vista, Nebraska-based Streck added.

Further, by eliminating the need for immediate plasma preparation, the tube allows for convenient transportation from the collection site to a centralized testing location or reference laboratory for analysis, the company said.

The FDA recently approved Redwood City, California-based Guardant Health's targeted next-generation sequencing liquid biopsy assay, Guardant360 CDx, for tumor mutation profiling in advanced cancer patients with any solid malignant neoplasm.