Roche 1st CLIA 'Moderate Complexity' tag for Ionify® 25-Hydroxy Vitamin D total test

Roche (OTCQX: RHHBY) has achieved a significant milestone as its Ionify® 25-Hydroxy Vitamin D total assay becomes the first mass spectrometry-based test to receive CLIA 'Moderate Complexity' designation from the FDA. The test runs on the cobas® i 601 analyzer, part of the cobas® Mass Spec solution.

This breakthrough enables broader access to advanced testing across routine clinical laboratories, moving beyond traditionally specialized labs. The system offers a fully automated, standardized workflow that combines mass spectrometry's sensitivity with improved efficiency. This is the first in Roche's planned U.S. pipeline for the cobas® Mass Spec solution, with additional launches expected globally.

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