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 blood collection tube to be cleared for use with liquid biopsy.
Biodesix, Inc. and Streck, Inc. today announced a Regulatory Cooperation Agreement that will further enable both companies in their pursuit of FDA approval for diagnostic testing services and specimen collection products.
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