Roche achieves CLIA ‘Moderate Complexity’ categorization for Ionify assay

Roche (RHHBY) announced that the U.S. Food and Drug Administration has categorized its Ionify 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988. This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories. “Achieving this level of automation for a mass spectrometry assay is a breakthrough for routine diagnostics,” said Brad Moore, President and CEO, Roche Diagnostics North America. “It will allow more labs to deliver highly accurate results efficiently, helping clinicians make better-informed decisions and ultimately improving patient care.”