The Ionify\u00ae steroid assays include Estradiol, DHEA, DHEA-S, Progesterone, 17-Hydroxyprogesterone and Androstenedione, which run on Roche’s cobas\u00ae i 601 analyzer as part of the cobas\u00ae<\/a>\u00a0Mass Spec solution<\/a>. By combining the sensitivity and specificity of mass spectrometry with a standardized, easy-to-use workflow, the cobas\u00ae Mass Spec solution streamlines complex testing and helps reduce variability across laboratories.<\/p>\n “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 \u2013 helping ensure the right treatment reaches the right patient without delay.”<\/p>\n The Ionify\u00ae steroid assays, together with the previously launched Ionify\u00ae 25-Hydroxy Vitamin D total assay, form the growing U.S. portfolio for the cobas\u00ae 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.<\/p>\n Story Continues <\/p>\n About the cobas\u00ae Mass Spec solution In July 2025, the cobas\u00ae Mass Spec solution received the “Best New Clinical Diagnostics Instrumentation of 2024” award in the Scientists’ Choice Awards\u00ae 2025. Established in 2007 by SelectScience, the awards recognize innovations nominated and voted on by the global scientific community.<\/p>\n For more information about cobas\u00ae Mass Spec, please visit go.roche.com\/ClinicalMassSpec<\/a>.<\/p>\n About\u00a0Roche 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.<\/p>\n Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.<\/p>\n For more information, please visit www.roche.com<\/a>.<\/p>\n All trademarks used or mentioned in this release are protected by law.<\/p>\n For Further Information<\/p>\n Roche Diagnostics U.S. Media Relations Amy Lynn Jen Dial Media assets:<\/p>\n ![\"Roche](\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/03\/ddae411f5257d9a3530e1fa3804c566f.jpeg\")
<\/a> Roche Logo (PRNewsfoto\/Roche) <\/p>\n
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\u00ae Mass Spec solution combines the high specificity, sensitivity and accuracy of mass spectrometry with a fully automated, integrated, and standardized workflow \u2013 making this traditionally complex analytical method accessible to routine laboratories.<\/p>\n
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.<\/p>\n
us.mediarelations@roche.com<\/a><\/p>\n
1-317-750-7811
amy.lynn@roche.com<\/a><\/p>\n
1-463-867-0232
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