Roche expands mass spectrometry menu to include steroid assays receiving CLIA 'moderate complexity' designation

Rhea-AI Summary

Roche (OTCQX: RHHBY) announced on March 18, 2026 that the FDA has classified its Ionify steroid assays as CLIA "moderate complexity," expanding routine clinical access to mass spectrometry testing. The assays (Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone, Androstenedione) run on the cobas i 601 analyzer.

The designation follows Roche's earlier Ionify 25-Hydroxy Vitamin D Total approval and aims to standardize and automate mass spec workflows, reducing lab variability and enabling wider clinical adoption while Roche continues regulatory review of additional assays.

Positive

• CLIA "moderate complexity" designation for Ionify steroid assays broadens lab access
• Six steroid assays (Estradiol, DHEA, DHEA-S, Progesterone, 17-OHP, Androstenedione) added to menu
• Runs on cobas i 601 enabling automated, standardized mass spectrometry workflows
• Builds on existing Ionify Vitamin D Total clearance to form a growing U.S. mass spec portfolio

Negative

• Mass spectrometry testing has been historically limited to specialized laboratories
• Additional Ionify assays remain under regulatory review, creating timing uncertainty for further expansion

• Roche's Ionify® steroid assays join its Vitamin D Total test as the latest mass spectrometry tests to receive CLIA 'moderate complexity' classification.
• The expanded steroid menu brings the sensitivity and specificity of mass spectrometry – the diagnostic gold standard – into routine clinical laboratories.
• The CLIA classification broadens access to advanced testing through a fully automated and standardized workflow on the cobas® i 601 analyzer.

INDIANAPOLIS, March 18, 2026 /PRNewswire/ -- 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," said Brad Moore, President and CEO, Roche Diagnostics North America. "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."

The Ionify® steroid assays, together with the previously launched Ionify® 25-Hydroxy Vitamin D total assay, form the growing U.S. 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, please visit go.roche.com/ClinicalMassSpec.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

For Further Information

Roche Diagnostics U.S. Media Relations
us.mediarelations@roche.com

Amy Lynn
1-317-750-7811
amy.lynn@roche.com 

Jen Dial
1-463-867-0232
jen.dial@roche.com

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SOURCE Roche Diagnostics

FAQ

What did Roche (RHHBY) announce on March 18, 2026 about Ionify steroid assays?

Roche announced that the FDA designated its Ionify steroid assays as CLIA "moderate complexity." According to Roche, this classification enables routine clinical laboratories to offer automated mass spectrometry testing on the cobas i 601, expanding patient access beyond specialized labs.

Which steroid assays are included in Roche's Ionify menu running on cobas i 601 (RHHBY)?

The Ionify steroid panel includes Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone, and Androstenedione. According to Roche, these assays operate on the cobas i 601 as part of the cobas Mass Spec solution with automated, standardized workflows.

How does the CLIA "moderate complexity" designation affect laboratory access to Roche mass spectrometry tests?

The designation broadens access by allowing routine clinical labs to run these tests without specialized operators. According to Roche, standardization and automation on the cobas i 601 reduce workflow complexity and variability across laboratories, enabling wider adoption.

Does Roche (RHHBY) already have other Ionify tests with CLIA moderate complexity?

Yes, Roche previously launched the Ionify 25-Hydroxy Vitamin D Total assay with the same designation. According to Roche, the Vitamin D assay plus the newly designated steroid assays form a growing U.S. mass spectrometry portfolio.

Are there more Ionify assays coming to market from Roche (RHHBY)?

Roche says it maintains an active pipeline of future clinical mass spectrometry assays currently in development and under regulatory review. According to Roche, additional assays are planned to further extend system and assay availability, though timing is subject to review.