SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug major Roche Holding AG (RHHBY, RO.SW, ROG.SW) announced Monday the U.S. Food and Drug Administration (FDA) 510(k) clearance of the cobas eplex respiratory pathogen panel 3 (RP3).
Designed for the automated cobas eplex system, this flexible syndromic test offers up to five customizable panel configurations, enabling labs and clinicians to rapidly and accurately identify the cause of respiratory infections to help ensure timely and effective patient care.
With an automated 'sample-to-answer' workflow process, the test requires less than one minute of hands-on preparation time and supports 24/7 availability. It also delivers highly accurate, qualitative results in less than two hours.
This FDA clearance further expands Roche's respiratory portfolio, which includes a broad range of singleplex and multiplex assays for respiratory viral and bacterial infections, supporting patient testing needs across the continuum of care.
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