AI and the rise of blood-based biomarkers heralds new era for neurological diagnostics
Quanterix Director of Medical Affairs discusses the advances revolutionizing Alzheimer’s diagnosis and care
8 Oct 2025
Lindsey Mette, Director of Medical Affairs at Quanterix
Advances in blood-based biomarkers are transforming early and accurate Alzheimer’s disease detection, offering less invasive, cost-effective alternatives to traditional diagnostic methods. Quanterix, a company working at the very frontiers of neurology, is pioneering some of these innovations, integrating novel assays and partnerships to improve diagnostic precision and clinical adoption. In this exclusive SelectScience® interview, we speak to Lindsey Mette, Director of Medical Affairs at Quanterix to learn more.
Quanterix has been at the forefront of plasma-based biomarker development, including p-Tau 217 and BD-Tau. What makes these markers so promising for early and accurate Alzheimer’s detection?
Mette: Biomarkers including p-Tau 217 and BD-Tau hold significant promise for early and accurate Alzheimer's disease (AD) detection due to their ability to provide non-invasive and highly accurate diagnostics faster, rivaling traditional methods - invasive, costly, and logistically complex tools like PET (positron emission tomography) scans and CSF (cerebrospinal fluid) testing to receive a diagnosis.
These biomarkers allow for the early detection of AD pathology, potentially up to 20 years before symptoms arise, thus enabling earlier and more effective interventions before the disease has progressed. By providing actionable insights to clinicians caring for patients with cognitive impairments, blood-based biomarkers support more confident diagnosis without requiring multiple confirmation tests, saving precious time on the patient treatment journey.
The high diagnostic accuracy of plasma biomarkers including p-Tau 217 and BD-Tau, with strong predictive values, strengthens their utility in confirming or ruling out AD. Moreover, their non-invasive nature has the potential to enhance accessibility globally, particularly in areas with limited access to conventional diagnostic tools, thereby reducing underdiagnosis. Additionally, the cost-effectiveness of blood-based biomarker tests compared to PET scans supports their feasibility for widespread screening and regular monitoring. These advancements, powered by platforms like Simoa, provide essential tools for early diagnosis and precision therapies that could significantly improve patient care outcomes.
Quanterix recently shared details of findings into lithium deficiency and the onset of Alzheimer’s disease, what were the key findings and what implications could they have on Alzheimer’s detection and treatment?
Mette: The Nature study, “Lithium deficiency and the onset of Alzheimer’s disease,” provides compelling evidence linking lithium levels in the brain to development and progression of AD. It found lithium deficiency in early-stage Alzheimer's brains and demonstrated that tiny doses of lithium orotate not only halted memory loss in mice but reversed signs of advanced disease. These findings could pave the way for new treatments, enable novel biomarker-based diagnostics, and redefine the clinical approach to AD. The study suggests that lithium levels could serve as early biomarkers for AD, potentially allowing for earlier diagnosis and intervention.
What new biomarkers or assay formats are in development to further enhance diagnostic precision for Alzheimer’s and related conditions?
Mette: Quanterix recently launched two novel phospho-tau assays: p‑Tau 205 and p‑Tau 212. These new assays enable the precise detection of tau phosphorylation sites, biomarkers increasingly associated with early and progressive stages of Alzheimer’s disease. These assays empower researchers to explore novel disease mechanisms, refine patient stratification, and support therapeutic development through fluid-based biomarkers.
Additionally, with the recent integration of Akoya’s spatial biology platform, we’re bringing spatial biology and ultra-sensitive detection of proteins together. This means researchers will not only know that a rare protein biomarker is present – it will also help determine which cell, where, and in what microenvironment. This provides a fuller view of immune activity and could enable earlier disease detection and prognosis, significantly improving patient outcomes by offering a two-dimensional view of pathobiology.
Current tissue analysis methods in the industry deliver meaningful data but fail to bring it all together – Quanterix’s Simoa platform enables ultra-sensitive detection of proteins and novel blood-based biomarkers and Akoya’s spatial solutions across discovery, translation, and clinical research adds context. Together, the Simoa digital immunoassay and spatial biology unlocks depth and context and more holistic insights from tissue to fluid.
What steps is Quanterix taking to navigate regulatory pathways and support clinical adoption of blood-based Alzheimer’s tests?
Mette: We are taking a multi-pronged approach to move our blood-based biomarker tests from research to routine clinical use. The path from biomarker discovery to regulatory approval and clinical use is long and complex, and the clinical lab is where a significant amount of that critical translational work happens. Quanterix’s Accelerator Laboratory is enabling clinical researchers to advance biomarker discovery and development through direct partnerships with pharma and life science companies.
Tests such as our LucentAD Complete® consolidate multiple tests, analyzing 5 unique biomarkers, (p-Tau 217, Aβ42/40, NfL, GFAP) with an algorithmic score to indicate probability of amyloid pathology, in one blood test. This next generation, multi-marker blood test is designed to integrate seamlessly into clinical workflows and removes variability in diagnoses, driving the treatment of Alzheimer’s and other neurological diseases forward by facilitating early intervention, the most critical time in management of these diseases.
At the same time, we are broadening our assay portfolio with new phospho-tau assays including p‑Tau 205 and p‑Tau 212, publishing validation data and presenting findings at major scientific meetings to build the evidence base regulators, clinicians, and payers need. Together, these steps position Quanterix to achieve regulatory clearance and support widespread clinical adoption of simple, scalable blood-biomarker tests for Alzheimer’s disease.
We are actively obtaining global regulatory validation, exemplified by the recent Class 1 Medical Device registration of the HD-X Simoa Immunoassay Analyzer in South Korea. The continued expansion of the industry-leading Simoa® technology platform into global markets demonstrates a key milestone in broadening validation of biomarker-based testing and providing clinicians with minimally invasive tools that can help enhance diagnostic accuracy and improve accessibility.
Quanterix has established several new global collaborations with laboratories and patient testing centers, further strengthening the infrastructure for Alzheimer’s testing and reinforcing its clinical utility. Recent collaborations include ARUP Laboratories, Neurogen Biomarking and NSW Health Pathology.
How do you envision artificial intelligence and machine learning integrating with biomarker data to personalize Alzheimer’s diagnosis and care?
Mette: The integration of artificial intelligence (AI) and machine learning (ML) with biomarker data holds transformative potential for personalizing Alzheimer’s diagnosis and care. By leveraging AI and ML, clinicians can sift through vast datasets of biomarker information to identify patterns and correlations that may not be immediately apparent through traditional analysis. This process enables the development of individualized patient profiles, facilitating early and accurate diagnosis of Alzheimer's disease.
AI and ML models can analyze comprehensive biomarker data, including blood-based markers like phosphorylated tau (P-tau) and neurofilament light (NfL), to predict disease progression or potentially tailor treatment plans to the patient's unique biological characteristics. This personalized approach not only improves diagnostic accuracy but also allows for the optimization of therapeutic interventions, ensuring that patients receive the most effective treatments based on their specific molecular signatures.
Furthermore, integrating AI and ML into biomarker analysis can streamline the drug development process by identifying potential therapeutic targets and enabling more efficient clinical trial design. Overall, the fusion of these advanced technologies with biomarker data heralds a new era in Alzheimer's care, where diagnosis and treatment are not only more precise but also more attuned to the individual needs of each patient.
What partnerships or collaborations are helping Quanterix accelerate innovation in neurodegenerative disease diagnostics?
Mette: Quanterix is accelerating innovation in neurodegenerative disease diagnostics through several key partnerships and collaborations. One significant collaboration is with ARUP Laboratories, a leading national reference laboratory. ARUP launched a blood test for phosphorylated tau 217 (P-tau217) to assist in identifying Alzheimer's disease pathology, utilizing Quanterix’s Simoa platform. This test, supported by antibody technology licensed from Eli Lilly, exemplifies Quanterix's approach to enhancing diagnostic accuracy and expanding clinical adoption.
Additionally, Quanterix has partnered with Neurogen Biomarking to introduce an at-home blood biomarker collection test to measure P-tau217, facilitating Alzheimer’s disease detection. This collaboration supports ease of access and usability for early diagnosis.
A partnership with Rede D’Or in Brazil focuses on reducing the underdiagnosis of Alzheimer's disease. Rede D’Or acquired the Simoa HD-X platform and implemented both P-tau217 and Neurofilament light chain (NfL) tests, further exhibiting Quanterix's commitment to improving disease detection and management globally.
Moreover, Quanterix completed its acquisition of Akoya Biosciences, combining advanced spatial proteomics with its existing capabilities, thereby providing a more comprehensive approach to biomarker discovery and diagnostics across neurology, oncology, and immunology. Through these strategic partnerships and expansions, Quanterix is advancing the frontiers of precise and personalized medical diagnostics.
This interview is published as part of the global CLINICAL24 conversation, highlighting challenges facing clinical laboratories and exploring the technology solutions to overcome them.