INDIANAPOLIS, March 18, 2026 — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 (CLIA). 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 Ionify® steroid assays include Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone and Androstenedione, which run on Roche’s cobas® i 601 analyzer as part of the cobas® Mass Spec solution. By combining the sensitivity and specificity of mass spectrometry with a standardized, easy-to-use workflow, the cobas® Mass Spec solution streamlines complex testing and helps reduce variability across laboratories.
“This technology fundamentally transforms mass spectrometry, moving it from an intricate specialty process to a seamless engine for routine diagnostics. 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,” said Brad Moore, president and CEO of Roche Diagnostics North America.
The Ionify® steroid assays, together with the previously launched Ionify® 25-Hydroxy Vitamin D total assay, form the growing US portfolio for the cobas® Mass Spec solution with a CLIA "moderate complexity" designation. This classification significantly broadens accessibility, enabling laboratories to routinely offer clinical mass spectrometry assays without the need for specialized operators. Roche remains committed to expanding this menu and maintains an active pipeline of future clinical mass spectrometry assays currently in development and under regulatory review to further extend system and assay availability.
About the cobas® Mass Spec solution
Mass spectrometry is widely regarded as the diagnostic gold standard for a range of clinical applications, including the measurement of steroid hormones in endocrinology and 25-hydroxyvitamin D testing. The cobas® Mass Spec solution combines the high specificity, sensitivity and accuracy of mass spectrometry with a fully automated, integrated, and standardized workflow—making this traditionally complex analytical method accessible to routine laboratories.
In July 2025, the cobas® Mass Spec solution received the “Best New Clinical Diagnostics Instrumentation of 2024” award in the Scientists' Choice Awards® 2025. Established in 2007 by SelectScience, the awards recognize innovations nominated and voted on by the global scientific community.
For more information about cobas® Mass Spec, visit go.roche.com/ClinicalMassSpec.
