The ALZpath Difference
ALZpathDx offers an approach to Alzheimer's diagnosis that is accessible, timely, cost-effective and less invasive than current testing methods.
ALZpathDx measures pTau217 in blood, which can signal amyloid and tau accumulation in the brain years prior to the onset of cognitive symptoms. Additionally, ALZpathDx correlates strongly with prior diagnostic methods, including PET imaging.
A transformation of Alzheimer's disease clinical care is possible with blood-based biomarkers
The introduction and widespread use of accurate and accessible blood-based diagnostics for Alzheimer’s disease will revolutionize treatment possibilities. It will enable doctors, patients and their families to make more informed decisions much earlier in the disease process.
ALZpath has established a robust and scalable plasma-based ultra-sensitive assay, branded ALZpathDx, utilizing a proprietary monoclonal pTau217 antibody and peptide calibrator. This ultra-sensitive blood-based ELISA assay has been developed on the semi-automated single-molecule array (Simoa®) platform. ALZpathDx has been launched for clinical use as laboratory-developed test (LDT). Evaluation in independent clinical cohorts with multiple co-morbidities is currently being established to advance to an in-vitro diagnostic (IVD).
Support and treatment options for Alzheimer's disease
Timely diagnosis is crucial as it allows for early intervention, providing patients with more time to plan and partner in slowing the progression of the disease. From available treatments to lifestyle modifications and support services, healthcare providers bring critical information and resources to assist their Alzheimer’s patients.
- Available Clinical Treatments:
- Disease Progression: Lecanemab, Leqembi, Aducanumab
- Symptoms: Cholinesterase Inhibitors, Glutamate Regulators
- Non-Cognitive Symptoms: Orexin Receptor Antagonist
- Lifestyle modifications may slow cognitive decline
- Several types of therapies can improve patient wellness including occupational therapy, speech therapy, and cognitive therapy with a specialized provider
- Planning for the future is possible with timely diagnosis, enabling financial planning and long-term care considerations to ensure appropriate support and resources
- Support groups allow patients and caregivers to connect, share experiences, and find emotional support
- Access to valuable educational resources, for example those provided by the Alzheimer’s Association, will deepen understanding of the disease and enhance caregiving skills
Benefits and Applications of pTau217
Screening
- Triage or categorize specialist waiting lists
- Clinical trial screening
- Screen cognitively healthy individuals at-risk of developing AD
Aid-in-diagnosis
- Diagnostic aid in individuals with cognitive concerns or low cognitive scores
- Differential diagnosis when a patient has competing diagnoses
Monitoring
- Triage or categorize specialist waiting lists
The evolution of Alzheimer’s Disease diagnosis
Limitations to Historical Alzheimer's Diagnostic Approaches
Cognitive testing has traditionally been the primary method to diagnose Alzheimer’s disease, however, relying solely on cognition has limitations because patients only show symptoms after significant changes have occurred in the brain. Historically, the only definitive way to confirm an Alzheimer’s disease diagnosis was through autopsy.
Over the past 20 years, brain imaging techniques like PET, CT, and MRI have been developed to assist in diagnosing Alzheimer’s disease with more certainty but are expensive, expose patients to radiation, and may not be accessible for many individuals.
Biomarkers Enable the Next Phase of Clinical Care
As a more accessible and simple approach to understanding brain health, many are turning to biomarkers in peripheral fluids. In the last decade, cerebrospinal fluid (CSF) biomarker assessments have become an important diagnostic tool alongside bioimaging. However, obtaining CSF has its own challenges.
Now, we can detect biomarkers in blood. This is considered the future of diagnosing Alzheimer’s disease. pTau217 outperforms other Alzheimer’s diagnostic biomarkers, including CSF and PET scans, to predict the likelihood of Alzheimer’s disease prior to the onset of symptoms.
Partner with us to bring ALZpathDx to your patients
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Publications of Interest
Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease
Lilly Investors News Release, 2023
Clinical Practice in the Alzheimer’s Biomarker Era – Drugs for the Brain and Care for the Mind
JAMA Network Open, 2023
Alzheimer Disease Biomarkers in Clinical Practice: A Blood-Based Diagnostic Revolution
Journal of Primary Care & Community Health, 2022
Longitudinal plasma p-tau217 is increased in early stages of Alzheimer's disease
Brain, The Journal of Neurology, 2020
