The landscape of Alzheimer’s disease research is shifting, with new tools emerging to aid in earlier and more accurate diagnosis. Siemens Healthineers has announced the launch of a comprehensive brain health research portfolio, featuring new assays designed to measure key biomarkers in blood samples. This development promises a less invasive approach to identifying individuals at risk of, or living with, neurodegenerative conditions like Alzheimer’s, potentially revolutionizing how these diseases are managed and treated.
At the heart of this expansion are the Atellica IM Phosphorylated tau 217 (pTau217) and Atellica IM Brain Derived Tau (BDTau) assays, now available for research use. These assays, run on Siemens Healthineers’ widely used Atellica Solution IM and Atellica CI Analyzers, offer researchers a way to quantitatively measure levels of these critical proteins in blood. Currently, diagnosing Alzheimer’s often relies on expensive and invasive procedures like PET scans and cerebrospinal fluid analysis. Blood-based biomarkers offer a potentially simpler, more accessible, and scalable alternative.
“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,” said Jim Freeman, Head of Core Laboratory Solutions R&D for Diagnostics at Siemens Healthineers. “Our Atellica IM instrument enables the high sensitivity required to detect neurological biomarkers in blood.”
The Promise of pTau217 and BDTau
The pTau217 biomarker has garnered significant attention in recent years for its accuracy in detecting Alzheimer’s pathology. According to research, the ALZpath pTau217 antibody, now licensed by Siemens Healthineers, demonstrates performance comparable to both PET imaging and cerebrospinal fluid testing. This means a simple blood draw could potentially provide a level of diagnostic certainty previously only achievable through more complex and costly methods. The ability to accurately identify individuals in the early stages of Alzheimer’s is crucial, as disease-modifying therapies grow increasingly available.
Henrik Zetterberg, MD, PhD, a leading neuroscientist known for his work on Alzheimer’s biomarkers, emphasized the importance of advanced analyzer technology. “Analyzer engineering is very crucial for amplifying the signal we need to achieve reliable results using blood tests,” he said. “Blood tests are much easier for both patients and doctors – you can scale testing, follow patients, or perhaps prepare a biomarker portfolio.”
Collaborative Research Efforts
Siemens Healthineers isn’t pursuing this research in isolation. The company is actively involved in several collaborative studies aimed at validating and expanding the clinical utility of these new biomarkers. These include multi-cohort research projects with PREDICTOM, ACCESS-AD, and the Banner Sun Health Research Institute. These partnerships are critical for establishing the reliability and generalizability of the assays across diverse populations.
Nicholas Ashton, PhD, senior director of the Fluid Biomarker Program at Banner Sun Health Research Institute in Arizona, highlighted the value of these collaborations. “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,” Ashton said. “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.”
Expanding the Brain Health Portfolio
Beyond pTau217 and BDTau, Siemens Healthineers is actively developing additional biomarkers to address a broader range of neurological conditions. The company already offers an assay with CE mark to help predict the risk of future Multiple Sclerosis disease activity. Further development is underway for biomarkers related to Apolipoprotein E-ε4 (ApoE-ε4), a protein linked to both Alzheimer’s disease and cardiovascular diseases. This comprehensive approach reflects a growing understanding of the interconnectedness of brain health and overall well-being.
With nearly 10 million new cases of dementia diagnosed globally each year, and Alzheimer’s disease accounting for 60-70% of those cases, the need for improved diagnostic tools is urgent. The Alzheimer’s Association estimates that the number of Americans living with Alzheimer’s will grow to nearly 13 million by 2050.
The introduction of these new assays represents a significant step forward in the quest for earlier and more accurate diagnosis of neurodegenerative diseases. Researchers will continue to refine and validate these biomarkers, paving the way for potential clinical applications that could transform the lives of millions affected by these devastating conditions. The next step involves further clinical validation studies to determine the precise role these blood tests will play in routine patient care.
What are your thoughts on the potential of blood-based biomarkers for Alzheimer’s disease? Share your comments below, and please share this article with anyone who might discover it informative.
