The Ionify steroid assay panel, which runs on the cobas i 601 analyzer, joins the previously cleared 25-Hydroxy Vitamin D total assay in Roche’s growing US mass spectrometry portfolio.
Roche announced that the Food and Drug Administration has categorized its Ionify steroid assays for mass spectrometry as “moderate complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), a designation the company says will broaden access to advanced diagnostic testing that has historically been confined to highly specialized laboratories.
The Ionify steroid assay panel includes Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone, and Androstenedione. All six assays run on Roche’s cobas i 601 analyzer as part of the cobas Mass Spec solution, which combines the sensitivity and specificity of mass spectrometry with a standardized, automated workflow designed to reduce variability across laboratories.
“This technology fundamentally transforms mass spectrometry, moving it from an intricate specialty process to a seamless engine for routine diagnostics,” says Brad Moore, president and CEO of Roche Diagnostics North America, in a release. “By delivering a broad and expanding mass spectrometry menu with automation and standardization, we are empowering laboratories to operate more efficiently and enabling clinicians to make critical decisions sooner—helping ensure the right treatment reaches the right patient without delay.”
Expanding the Moderate Complexity Portfolio
The newly designated steroid assays join the previously launched Ionify 25-Hydroxy Vitamin D total assay, which also carries a CLIA moderate complexity designation, forming what Roche describes as a growing US portfolio for the cobas Mass Spec solution. According to the company, the moderate complexity classification is significant because it removes the requirement for specialized operators, enabling routine laboratories to offer clinical mass spectrometry testing without the staffing and infrastructure demands typically associated with the technology.
Roche says it maintains an active pipeline of additional clinical mass spectrometry assays currently in development and under regulatory review, with the stated goal of further extending system and assay availability.
Recognition and Context
Mass spectrometry is widely regarded as a diagnostic gold standard for measuring steroid hormones in endocrinology and for 25-hydroxyvitamin D testing, according to Roche. The cobas Mass Spec solution received the “Best New Clinical Diagnostics Instrumentation of 2024” award in the Scientists’ Choice Awards 2025, presented by SelectScience, an honor determined by nominations and votes from the global scientific community.
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