Roche announced that the U.S. Food and Drug Administration (FDA) has categorized its Ionify 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories.
The assay runs on Roche’s cobas i 601 analyzer, part of the cobas Mass Spec solution. By combining mass spectrometry’s sensitivity and specificity with a standardized, easy-to-use workflow, the cobas Mass Spec solution streamlines complex testing and reduces variability across labs. Traditionally, these tests have been confined to highly specialized labs due to complex workflows and the need for expert operators.
The Ionify 25-Hydroxy Vitamin D total assay is the first in Roche’s planned U.S. pipeline for the cobas Mass Spec solution.
For more information, visit go.roche.com/USMassSpec.
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