Two new research-use assays measuring phosphorylated tau 217 and brain-derived tau are now available on the Atellica platform.
Siemens Healthineers has announced the availability of two new blood-based biomarker assays for research use: the Atellica IM Phosphorylated tau 217 (pTau217) and Atellica IM Brain Derived Tau (BDTau) assays. The launch marks an expansion of the company’s brain health research portfolio, with the tests designed to help scientists better understand neurological function and disease progression in conditions such as Alzheimer’s disease.
Both assays use chemiluminescent immunoassay technology to provide quantitative measurements of brain-derived p-tau217 and BD tau from blood samples, and are run on the Atellica Solution IM and Atellica CI Analyzers. According to Siemens Healthineers, the blood-based approach offers a less-invasive alternative to cerebrospinal fluid testing, which requires a lumbar puncture.
The launch comes amid a significant and growing global burden of neurodegenerative disease. According to the World Health Organization, nearly 10 million new cases of dementia are diagnosed worldwide each year, with Alzheimer’s disease accounting for 60–70% of those cases.
“Siemens Healthineers is laser focused on expanding researchers’ access to blood testing that can reduce the burden of invasive testing to better understand these diseases and help address the growing societal impact of neurodegenerative conditions,” says Jim Freeman, head of core laboratory solutions research and development for diagnostics at Siemens Healthineers, in a release. “Our Atellica IM instrument enables the high sensitivity required to detect neurological biomarkers in blood.”
Instrument Engineering as a Key Factor
For researchers working with blood-based neurological biomarkers, analytical sensitivity is a critical consideration. Henrik Zetterberg, MD, PhD, a neuroscientist known for his research on biomarkers of Alzheimer’s disease and other neurodegenerative disorders, highlighted the role of platform engineering in achieving reliable results.
“Analyzer engineering is very important for amplifying the signal we need to achieve reliable results using blood tests,” says Zetterberg, in a release. “Blood tests are much easier for both patients and doctors—you can scale testing, follow patients, or perhaps prepare a biomarker portfolio.”
Active Research Collaborations
Siemens Healthineers reports that several multi-cohort research collaborations are currently underway using the p-tau217 and BD tau biomarkers, including studies with PREDICTOM, ACCESS-AD, and Banner Sun Health Research Institute.
Nicholas Ashton, PhD, senior director of the Fluid Biomarker Program at Banner Sun Health Research Institute in Arizona, described the work being conducted with the plasma p-tau217 assay across diverse patient populations.
“We value the opportunity to work with the leading diagnostics companies to advance the fight against Alzheimer’s disease, and this is a great example,” says Ashton, in a release. “We’re working to validate the clinical utility of the plasma p-tau217 biomarker across diverse patient populations to advance early detection of Alzheimer’s disease. Our findings appear to support the promise of this Alzheimer’s blood biomarker in the clinical setting. We look forward to further advancing this research.”
Additional Biomarkers in Development
Beyond the pTau217 and BDTau research-use assays, Siemens Healthineers also offers a Neurofilament Light Chain assay—available with CE mark and for research use only in the US—intended to help predict the risk of future multiple sclerosis disease activity. The company says development efforts are also underway for Apolipoprotein E-ε4 (ApoE-ε4), a protein subtype implicated in both Alzheimer’s disease and cardiovascular diseases.
The pTau217 and BDTau assays are for research use only and are not cleared or approved for clinical decision-making.
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