Siemens Healthineers testosterone test receives CDC certification

Siemens Healthineers announced its Atellica IM Testosterone II assay received certification through the Centers for Disease Control and Prevention Hormone Standardization Program for Total Testosterone. The certification confirms the immunoassay test results are equivalent to high performance liquid chromatography coupled with tandem mass spectrometry, which is considered the gold standard analytical method.

The Atellica IM TSTII assay, available on Atellica IM and Atellica CI Analyzers, is the only fully automated immunoassay to achieve CDC HoSt-TT certification, which the company has maintained continuously since 2019. The certification ensures test result traceability and minimizes variability across laboratories.

"For women and children, testosterone levels are naturally low, which makes accurate measurement challenging," said Ross Molinaro, head of Medical Value and Evidence for Diagnostics at Siemens Healthineers. He noted the assay offers a routine testing method as an alternative to specialty testing.

Testosterone measurement is clinically important as abnormal levels may be associated with endocrine, metabolic, reproductive, and oncologic conditions. The hormone plays essential roles in sexual development, reproductive function, musculoskeletal health, and bone metabolism.

Scott Isaacs, adjunct professor for the Department of Medicine at Emory University School of Medicine, said the CDC standardization program ensures total testosterone results are accurate and comparable regardless of where testing is performed. The standardization reduces inter-laboratory variability and allows for more consistent diagnosis and treatment decisions.

An evaluation of the assay's performance was recently published in The Journal of Clinical Endocrinology & Metabolism. Siemens Healthineers (FRA: SHL) generated revenue of approximately €23.4 billion in fiscal 2025, according to the press release.

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