Roche announces FDA categorized its Ionify steroid assays

Roche (RHHBY) announced that the U.S. Food and Drug Administration, FDA, has categorized its Ionify steroid assays for mass spectrometry as “moderate complexity” under the Clinical Laboratory Improvement Amendments of 1988. “This designation marks an important step toward expanding access to advanced diagnostic testing, which has historically been limited to highly specialized laboratories due to complex workflows and the need for expert operators,” the company said.