Sept. 19, 2025—The Food and Drug Administration has categorized Roche’s Ionify 25-Hydroxy Vitamin D total assay as moderate complexity under the Clinical Laboratory Improvement Amendments of 1988. Roche reported that this is the first time a mass-spectrometry-based test has achieved this designation.
“Achieving this level of automation for a mass spectrometry assay is a breakthrough for routine diagnostics,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a press release. “It will allow more labs to deliver highly accurate results efficiently, helping clinicians make better-informed decisions and ultimately improving patient care.”
The assay runs on the Cobas i 601 analyzer, part of the Cobas Mass Spec solution.