Summary: Veravas and Phanes Biotech revealed promising analytical verification study results for the VeraBIND Tau assay, an innovative diagnostic test designed to detect active Alzheimer’s disease (AD) pathology with high accuracy.

Takeaways:

  1. Innovative Technology: The VeraBIND Tau assay utilizes Veravas’ proprietary VeraBIND platform to detect active tau pathology, achieving 94.2% sensitivity and 89.6% specificity in alignment with tau PET imaging.
  2. Global Accessibility: The test provides an affordable, accessible diagnostic tool for Alzheimer’s disease, enabling early detection in regions lacking advanced imaging capabilities.
  3. Clinical Impact: The assay could accelerate AD diagnosis, inform tau-directed therapeutic development, and address other tauopathies with potential to transform patient care.

Veravas, a leading innovator in clinical diagnostics, announced positive results of an analytical verification study of its VeraBIND Tau assay, a next-generation test being co-developed with Phanes Biotech, an early-stage biotech company focused on treatments for neurodegenerative diseases, for the detection of Alzheimer’s disease (AD). 

The VeraBIND Tau Assay

The test is designed to detect and measure disease pathology to enable the diagnosis of AD at its earliest, most treatable stages. Unlike first-generation tests that measure biomarkers indicative of potential disease, VeraBIND Tau is designed to detect active disease by studying measurable binding activity occurring in the brain between hyperphosphorylated tau (HPT) and normal tau (nTau), which is a hallmark of AD.(1) The test can also aid in the diagnosis of AD, giving clinicians an accessible, accurate, and affordable alternative to tau PET imaging.

Impact of Alzheimer’s Disease

AD is the sixth leading cause of death in the United States, afflicting an estimated 6.9 million Americans aged 65 or older.(2,3) It’s critical that clinicians have accessible tools to quickly and accurately diagnose and distinguish AD from other dementias causing cognitive impairment to enable targeted treatment. In AD, lifestyle modifications and emerging tau-directed therapies have shown promise in slowing or delaying cognitive decline.

“The VeraBIND Tau assay will enable Alzheimer’s disease diagnosis for the first time in geographies where tau PET imaging is not available” says Khalid Iqbal, chief scientific oficer of Phanes Biotech.

Data on VeraBIND Tau

Veravas demonstrated VeraBIND Tau’s ability to accurately measure the pathological activity of hyperphosphorylated tau. In this analytical verification study, the test protocol was performed on 100 retrospectively collected patient samples, including 52 confirmed positive for AD tau pathology via F18MK6240 tau PET imaging (of which, 19 had normal cognitive function, 21 had mild cognitive impairment, and 12 had dementia), 38 healthy controls, and 10 patients positive for beta amyloid plaques but negative by tau PET.(4) The data showed 94.2% sensitivity and 89.6% specificity resulting in an overall VeraBIND Tau assay agreement of 92.0% against tau PET imaging.

“These analytical data show that VeraBIND Tau can measure active tau pathology of AD both among individuals with and without cognitive impairment,” says Bernard Hanseeuw, MD, PhD, associate head of the Memory Clinic, Neurology Department, Saint Luc University Hospital in Belgium and Instructor at Mass General Hospital, Boston, MA. “The implementation of such a test could not only one day speed the diagnosis of AD, it could also be used to inform the development and testing of tau-directed therapeutics. It also holds great promise for non-AD tauopathies, as the assay proved positive in 7 out of 8 cases tested with low-amyloid, and positive tau-PET data”.

Further Reading

New Test Can Detect Patients’ Risk of Harmful Side Effects from Alzheimer’s Drugs

History of Veravas’ Technology

To co-develop the VeraBIND Tau assay, the companies used Veravas’ proprietary VeraBIND technology, a platform that is designed to capture and purify key proteins in blood to enable highly accurate protein detection and characterization. When combined with antibodies, VeraBIND magnetic nanobeads act as a filter for multiple sample types, enabling the removal of interfering substances that can obscure the biomarker of interest and potentially produce false results. This patented technology makes it possible to study low-abundance disease-causing proteins that may otherwise be undetectable by enriching samples pre-analytically to improve the detectability of the analyte.

“These results demonstrate the transformative potential of VeraBIND Tau to upend the standard of care for management of patients suspected of potentially having Alzheimer’s disease,” says Josh Soldo, chief scientific officer at Veravas. “Our highly accurate analytical test protocol can be performed quickly and cost-effectively and could potentially eliminate both the uncertainties associated with biomarker detection tests and the high costs and wait times associated with tau PET imaging, thereby helping clinicians get answers to their patients much more rapidly.”

References:

  1. Thal DR, Tomé SO. The central role of tau in Alzheimer’s disease: From neurofibrillary tangle maturation to the induction of cell death. Brain Res Bull. 2022;190:204-217. doi:10.1016/j.brainresbull.2022.10.006
  2. Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5).”
  3. Ahmad FB, Cisewski JA, Anderson RN. Mortality in the United States — Provisional Data, 2023. MMWR Morb Mortal Wkly Rep 2024;73:677–681. DOI: http://dx.doi.org/10.15585/mmwr.mm7331a1.
  4. Gérard T, et al. The spatial extent of tauopathy on [18F]MK-6240 tau PET shows stronger association with cognitive performances than the standard uptake value ratio in Alzheimer’s disease. Eur J Nucl Med Mol Imaging. 2024 May;51(6):1662-1674.