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Siemens Healthineers Expands Brain Biomarker Portfolio With New Assays

lite News Desk 2 min read

At a glance

  • Siemens Healthineers launched two automated brain biomarker assays in March 2026
  • Assays measure pTau217 and BDTau in blood for research use
  • Recent industry activity includes FDA designations and new assay launches

Recent developments in brain health research have included the introduction of new blood-based biomarker assays, offering additional tools for studying neurological conditions.

On March 19, 2026, Siemens Healthineers announced the launch of two fully automated brain-derived biomarker assays, Atellica IM Phosphorylated tau 217 (pTau217) and Atellica IM Brain Derived Tau (BDTau), for research use on its Atellica Solution IM and Atellica CI Analyzers. These assays are designed as chemiluminescent immunoassays that quantitatively measure pTau217 and BDTau in blood samples, providing a less invasive alternative to cerebrospinal fluid testing.

Siemens Healthineers is collaborating on research involving these biomarkers with several multi-cohort studies, including PREDICTOM, ACCESS-AD, and Banner Sun Health Research Institute. In addition to these efforts, the company offers a CE-marked assay for predicting future multiple sclerosis disease activity and is developing further biomarkers such as Apolipoprotein E-ε4 (ApoE-ε4.

In December 2025, Siemens Healthineers entered a licensing agreement with ALZpath, Inc. to utilize ALZpath’s proprietary pTau217 antibody in the development of its pTau217 assay for the Atellica immunoassay systems. The company also partnered with Cohen Veterans Bioscience in November 2025 to contribute data from its Atellica IM Neurofilament Light Chain assay and other biomarkers to the National Normative Neuroimaging Library (NNL) for brain health research.

What the numbers show

  • Siemens Healthineers announced new assays on March 19, 2026
  • ALZpath licensing agreement signed in December 2025
  • Cohen Veterans Bioscience partnership occurred in November 2025

Interest in pTau217 as a biomarker for Alzheimer’s disease has grown, with Roche’s Elecsys pTau217 plasma assay receiving FDA Breakthrough Device Designation in April 2024. Other companies have also expanded their portfolios, such as Quanterix, which launched commercial p-Tau 205 and p-Tau 212 assays in August 2025.

The SPEAR UltraDetect pTau217 assay was granted FDA Breakthrough Device Designation in January 2025, reflecting high analytical performance in research settings focused on Alzheimer’s disease. These developments indicate an expanding range of blood-based phospho-tau biomarkers available for research use.

Emerging research tools, including petBrain and TauGenNet, have integrated plasma pTau217 measurements with imaging techniques to support quantification and modeling of Alzheimer’s disease biomarkers. These tools, introduced in June and September 2025 respectively, contribute to ongoing efforts in the field.

Siemens Healthineers’ recent activities are part of a broader trend among companies and research organizations to advance blood-based biomarker assays for neurological research. These initiatives involve collaborations, licensing agreements, and the introduction of new assays to support studies in Alzheimer’s disease and other brain health conditions.

* This article is based on publicly available information at the time of writing.

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