Business
Roche expands mass spectrometry menu to include steroid assays receiving CLIA 'moderate complexity' designation
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® st
About this update from Roche Holding Ltd
[{"type":"list","items":[{"val":[{"type":"text","content":"Roche's Ionify® steroid assays join its Vitamin D Total test as the latest mass spectrometry tests to receive CLIA 'moderate complexity' classification.","length":164,"tagName":"p"}]},{"val":[{"type":"text","content":"The expanded steroid menu brings the sensitivity and specificity of mass spectrometry – the diagnostic gold standard – into routine clinical laboratories.","length":154,"tagName":"p"}]},{"val":[{"type":"text","content":"The CLIA classification broadens access to advanced testing through a fully automated and standardized workflow on the cobas® i 601 analyzer.","length":141,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":459,"olType":false},{"type":"text","content":"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.","length":971,"tagName":"p"},{"type":"image","alt":"Roche Logo (PRNewsfoto/Roche)","displaySize":"","headline":null,"caption":"Roche Logo (PRNewsfoto/Roche)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":208,"url":"https://media.zenfs.com/en/prnewswire.com/ddae411f5257d9a3530e1fa3804c566f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/eSQDLdZIDYgtsIFVCJlYYQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM2NztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/ddae411f5257d9a3530e1fa3804c566f","width":400,"height":208}},"href":"https://mma.prnewswire.com/media/651894/Roche_Logo.html","hrefExternal":true,"rel":"nof...