Roche has received a CLIA “moderate complexity” classification from FDA for its Ionify steroid assays for mass spectrometry. The designation is intended to expand access to advanced diagnostic testing, which has traditionally been confined to specialized laboratories because of complex workflows and the need for highly trained operators.
The Ionify steroid menu comprises Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone and Androstenedione, all run on the cobas i 601 analyzer as part of the cobas Mass Spec solution. By pairing the analytical sensitivity and specificity of mass spectrometry with a standardized, automated workflow, the system is designed to streamline complex testing and reduce variability between laboratories.
Roche stated that moving mass spectrometry from a specialized process into routine diagnostics can help laboratories operate more efficiently and support faster clinical decision-making. According to the company, a broader and expanding mass spectrometry test menu with automation and standardization is intended to help ensure appropriate treatments reach patients without unnecessary delay.
The newly classified Ionify steroid assays join the previously launched Ionify 25-Hydroxy Vitamin D Total assay to form a growing U.S. portfolio of cobas Mass Spec tests under the CLIA “moderate complexity” designation. Roche said this classification significantly broadens accessibility by allowing more laboratories to offer clinical mass spectrometry assays without requiring specialized operators. The company added that it maintains an active pipeline of additional clinical mass spectrometry assays in development and under regulatory review to further expand the system’s test menu.
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