Roche Secures FDA CLIA Waiver and CE Mark for Bordetella POC Test
Roche has received CE Mark approval for its first point-of-care test capable of diagnosing and differentiating Bordetella infections, including whooping cough, within 15 minutes. The rapid, PCR-accurate test enables faster clinical decisions and supports early intervention, particularly for vulnerable groups such as infants and the elderly.
FDA CLIA Waiver | 03/12/2025 | By Dineshwori | 101
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