FDA clears Cobas BKV test for urine samples

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“Transplant patients face a number of significant challenges, including complications that can arise from viruses like BKV,” Ann Costello, head of Roche Diagnostic Solutions, said in a press statement. “With the FDA clearance of this noninvasive and easily collectable sample type, we now offer choices for clinicians using a standardized, automated solution to routinely monitor and manage infection risks.”

The test is also approved for use in CE markets with EDTA plasma and urine stabilized in Cobas PCR media as sample types.