Veravas Inc., an innovator in diagnostics dedicated to advancing health outcomes through early disease detection, announced that two independent analyses, presented at the 2025 Alzheimer’s Association International Conference (AAIC), demonstrate that the VeraBIND Tau assay accurately measures active tau pathology—a key biomarker of Alzheimer’s disease (AD) and other tauopathies—in individuals with and without cognitive impairment.
Unlike currently available tests that quantify biomarker levels, the VeraBIND Tau assay measures the pathological binding activity between hyperphosphorylated tau and normal tau—a hallmark of AD noting the active spread of tau proteins—which provides a more direct measure of disease activity, that can be observed years before AD symptoms may appear. Assessing the level of binding activity as an indicator of the potential spread of hyperphosphorylated tau provides a more accurate and sensitive diagnostic approach, adding an important layer of understanding in the pathological progression of disease. The VeraBIND Tau assay is a blood-based test that detects tau pathology in adult patients aged 50 years and older, and produces results consistent with tau positron emission tomography (Tau-PET) brain scans.
One of the independent analyses presented at AAIC and conducted by Bernard Hanseeuw, M.D., Ph.D., Associate Head of the Memory Clinic, Neurology Department at Saint Luc University Hospital in Belgium and Instructor at Mass General Hospital in Boston, MA, evaluated the VeraBIND Tau assay against the industry’s gold standard for detecting tau pathology, MK6240 Tau-PET. MK6240 is a highly specific compound used in Tau-PET imaging for studying AD. Key findings include:
- Compared to three other plasma assays, VeraBIND Tau was shown most predictive of the MK6240 Tau-PET results.
- The analysis demonstrated that VeraBIND Tau has >95% sensitivity and 95% specificity to distinguish A+T+ (Amyloid positive and Tau positive) from A-T- cases (Amyloid negative and Tau negative, defined using PET), which is key for staging cognitively unimpaired (CU) individuals.
- The diagnostic accuracy is similar in cognitively impaired (CI) and CU individuals, driven by the high sensitivity of VeraBIND Tau in early stages of tau aggregation (PET-based Braak-like stages 1-3) – whereas current plasma tau methods, such as pTau217, tend to be driven by sensitivity at latter Braak stages (4-6), when symptoms are already present.
- A plasma test highly sensitive to early tau pathology like the VeraBIND Tau assay may be critical to identifying and staging individuals across the pathological continuum.
The second independent analysis, led and presented by Lisa Quenon, PhD, a postdoctoral researcher at Université catholique de Louvain in Belgium, investigated the impact of early aggregation of tau on cognitive impairment. Her key findings:
- VeraBIND Tau is a more targeted measure of tau aggregation than plasma p-Tau17, a commonly used blood-based biomarker for AD.
- Confirms VeraBIND Tau correctly identifies MK6240-positive individuals, with or without cognitive impairment and regardless of amyloid status.
- VeraBIND Tau positive individuals scored lower on cognitive assessments than negative individuals.
“The implications of these initial findings are transformative. Earlier diagnosis can enable patients to make informed decisions about their future – including exploring currently available therapies, working with clinicians to assess and implement evidence-based lifestyle changes that may slow the progression or lessen the severity of their AD; talking with loved ones about planning and managing care; and potentially participating in clinical trials to access emerging treatments sooner,” said John Forrest, Co-Founder, CEO, & Executive Chairman of Veravas. “This breakthrough technology can also support industry in expediting clinical trial recruitment and lessening trial duration. We look forward to supporting industry, researchers, and healthcare providers to address a huge unmet need and provide a new source of hope to patients and their families.”
“As a clinician, a diagnostic option that is less invasive and more accessible to patients is incredibly important. Currently there are no clinically available blood tests that can accurately predict the presence of tau aggregates in the brain before the onset of clinical symptoms. Being able to build upon existing evidence that reinforces the high degree of accuracy the VeraBIND Tau assay is both exciting and encouraging,” said Dr. Hanseeuw.
The analyses presented at AAIC follow a prior study conducted by Veravas and Saint Luc University Hospital that showed the assay correctly identifies MK6240 Tau-PET positive individuals, with or without cognitive impairment, regardless of amyloid status.
“The compelling data presented by Dr. Hanseeuw and Dr. Quenon underscore the immense power of the VeraBIND Tau assay to support early AD detection and ultimately revolutionize how we approach Alzheimer’s diagnosis, management and treatment,” said Josh Soldo, Chief Scientific Officer & Co-Founder of Veravas.
AD is the sixth leading cause of death in the United States, afflicting an estimated 7.2 million Americans aged 65 or older.1 Current diagnostic methods often involve invasive and expensive procedures or are only effective in later stages of the disease, limiting the window for effective therapeutic intervention.
Veravas is committed to supporting the advancement of innovative diagnostic solutions. The VeraBIND Tau assay is a laboratory developed test in a CLIA and CAP certified laboratory and is available to clinicians and researchers today.