Veravas, Inc.

New non-invasive test offers 96% sensitivity and 90% specificity, empowering earlier and more accessible Alzheimer's detection AUSTIN, Texas, April 22, 2025 /PRNewswire/ -- Veravas, a leader in clinical diagnostics, today announced the general commercial availability of VeraBIND™ Tau, the first blood-based test designed to aid in the detection of Alzheimer's disease (AD) and other tau-related neurodegenerative disorders (tauopathies). The first-in-class assay is available now as a laboratory-developed test (LDT) through Veravas. It was validated and is performed in a CLIA / CAP certified lab. Continue Reading VeraBIND Tau is designed for use in both symptomatic and presymptomatic patients, enabling earlier diagnosis when intervention is most effective. General Commercial Release of VeraBIND Tau - Blood Test for Alzheimer's-Related Tau Pathology Post this "Detecting tauopathy early gives patients and healthcare providers a better chance to take action before cognitive decline sets in," said John Forrest, CEO of Veravas. "VeraBIND Tau takes a novel approach by measuring pathological tau activity—a key driver of neurodegeneration that is closely linked to near-term cognitive decline." A Breakthrough in Alzheimer's Diagnostics Until now, detecting tau pathology required invasive spinal taps or expensive tau PET imaging, which has not been practical for many patients. VeraBIND Tau makes this information available through a convenient and accessible blood test. Other blood tests measuring amyloid plaque provide a risk indication but are not as closely correlated to near-term cognitive decline. In an analytical verification study, the test demonstrated: 96% sensitivity, 90% specificity, 92% agreement with tau PET imaging. This makes it ideal for clinical trial screening, providers and patients looking to gain earlier insight into brain pathology and health plans hoping to better manage the brain health of their populations. These results show that VeraBIND Tau reliably detects the abnormal tau accumulation associated with Alzheimer's and provides a VeraBIND Tau Score, a semi-quantitative measure of pathologically active tau. Validation demonstrates performance comparable to current gold-standard imaging. Clinical Impact and Accessibility VeraBIND Tau is now available for use by clinicians, plans, researchers, and clinical trial sponsors. The test must be ordered under the care of a physician. "This test offers a practical and innovative way to give patients and families critical information they can act on," said Jeff Donohue, M.D., a board-certified family physician in Holly Springs, Georgia. "Having a clear picture of tau pathology will help guide treatment decisions, lifestyle interventions, and care planning—potentially slowing disease progression." About VeraBIND Tau and Veravas VeraBIND Tau uses Veravas' proprietary VeraBIND™ platform, which isolates and measures hyperphosphorylated tau aggregating to normal tau—a key pathological marker of Alzheimer's—in blood samples. This enables early detection to identify risk of cognitive decline even in cognitively normal individuals. For more information or to access test requisition materials, visit . About Veravas Veravas is a leading innovator in clinical diagnostics focused on early detection and prognostic screening for Alzheimer's disease and other neurological conditions. The company's proprietary VeraBIND™ technology transforms challenging sample types into measurable biomarkers, enabling earlier disease detection and the development of novel diagnostic tests. Its VeraBIND Tau assay is a first-in-class blood-based test that measures the pathological activity of hyperphosphorylated tau in blood samples of cognitively normal individuals or individuals experiencing cognitive impairment which may be used to aid in the diagnosis of Alzheimer's disease. Learn more at Veravas.com and follow us on LinkedIn. SOURCE Veravas, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AUSTIN, Texas--( BUSINESS WIRE )--Veravas, a leading innovator in clinical diagnostics, today announced the 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 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. 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. 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 F18 MK6240 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,” said Bernard Hanseeuw, M.D., Ph.D., 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”. To co-develop the VeraBIND Tau assay, the companies used Veravas’s 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,” said 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.” “The VeraBIND Tau assay will enable Alzheimer’s disease diagnosis for the first time in geographies where tau PET imaging is not available” said Khalid Iqbal, Chief Scientific Officer of Phanes Biotech. For more information about the VeraBIND Tau assay and other VeraBIND products, visit www.veravas.com . About Veravas Veravas is a leading innovator in clinical diagnostics focused on early-stage detection and prognostic screening for Alzheimer’s disease and other neurological conditions. The company’s proprietary VeraBIND™ technology transforms challenging sample types into measurable biomarkers, enabling earlier disease detection and the development of novel diagnostic tests. Its VeraBIND Tau assay is a first-in-class blood-based test that measures the pathological activity of hyperphosphorylated tau in blood samples of cognitively normal individuals or individuals experiencing cognitive impairment which may be used to aid in the diagnosis of Alzheimer's disease. Learn more at Veravas.com or follow us on LinkedIn . About Phanes Biotech Phanes Biotech is an early-stage biotech company focused on developing breakthrough treatments for neurodegenerative diseases, including Alzheimer’s, macular degeneration, traumatic brain injury, stroke, Down syndrome-associated Alzheimer’s, and cognitive aging. Phanes takes a unique and differentiated approach to Alzheimer’s and other neurodegenerative diseases, setting it apart from existing therapies and drugs currently in development. The company’s pipeline includes innovative drugs: (1) Neuroregenerative small molecule P021 – This promising therapeutic aims to address Alzheimer’s disease by shifting the balance from neurodegeneration toward neural regeneration. (2) Immunotherapy PB43D – A potent, high-affinity antibody designed to target and bind to tau. It is the only antibody shown to reduce both tau and Aβ pathologies. Through a strategic partnership, Phanes leverages its portfolio of tau-targeting antibodies to develop a groundbreaking, first-in-class blood-based assay. This innovative diagnostic tool aims to detect and measure tau pathology activity in the brain, setting a new standard for diagnosing and tracking the progression of Alzheimer’s disease. Learn more at Phanesbiotech.com or follow us on LinkedIn . 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 Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement 2024;20(5)." 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 . 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.

Revolutionary bead-based technology enables reliable biomarker detection in challenging samples, transforming clinical diagnostic performance and research workflows AUSTIN, Texas, June 20, 2023 /PRNewswire/ -- Today, Veravas, a leading innovator in clinical diagnostics, announced the launch of its groundbreaking Vera BIND™ ( Biomarker Isolation and N-richment for Detection) technology. With millions of assays conducted daily in clinical laboratories worldwide, the search for specific biomarkers to identify early-stage diseases is becoming increasingly crucial. However, the inherent challenges posed by diverse patient sample types, including urine, saliva, and blood, can lead to false positive or negative results. VeraBINDing the sample during collection or preparation transforms complex samples into a matrix-free sample which enhances the performance of on-market tests and can allow healthcare professionals to realize a significant breakthrough in biomarker detection. VeraBIND technology offers a unique and comprehensive solution that improves the accuracy of biomarker detection and minimizes the occurrence of false positive or negative results across various sample types. By implementing this groundbreaking innovation, clinical laboratories can optimize their diagnostic processes and contribute to early disease detection, thereby enabling timely and targeted interventions. VeraBIND also paves the way for faster assay development, offering consistency and improved accuracy in research, clinical trials, and diagnostic tests. "VeraBIND is a game-changer for the clinical diagnostics industry, as it addresses the most difficult challenges in assay development," said John Forrest, CEO of Veravas. "By standardizing and simplifying the sample matrix, we are revolutionizing early biomarker detection for Alzheimer's and other diseases, leading to better patient outcomes." Designed for use in clinical diagnostics and research, VeraBIND improves workflows and enables more sensitive detection of low abundance or previously hidden biomarkers. Once validated, it works with commercially available assays and can be run using any detection method, such as ELISA, chemiluminescence, and mass spectrometry. "By creating a new matrix-free sample, VeraBIND enables biomarkers to be examined easily, offering clinicians faster, more accurate testing and diagnosis," said Josh Soldo, Chief Scientific Officer at Veravas. "Eliminating sample interferences and enriching biomarkers of interest results in superior detection. This advancement ensures assays leveraging VeraBIND can be standardized for more efficient analysis." With VeraBIND, Veravas is redefining assay development and biomarker detection, setting a new standard in clinical diagnostics and research. Through improved accuracy and streamlined workflows, both clinicians and researchers can expect better outcomes and enhanced quality of life for patients worldwide. "Our laboratory specializes in the use of an oral rinse collection to test for common and esoteric analytes" states Dr. Ron McGlennen, Medical Director of Access Genetics. "We are excited about the prospects of VeraBIND to accelerate the validation of Alzheimer's and Celiac Disease tests normally limited to testing on blood to now include saliva. This will expand the market for convenience and at home-based testing, which now is the leading edge of innovation in diagnostics for healthcare." About Veravas, Inc. Veravas is an emerging diagnostic company dedicated to early disease detection in challenging sample types. Designed for convenience, accuracy, and cost-effectiveness, Veravas' products help improve clinical research and allow laboratories and manufacturers to develop and run ultra-sensitive assays for early-stage disease detection, prognostic screening, and precision medicine. The company is currently developing novel saliva tests for Alzheimer's, Lyme, and Celiac diseases. For more information, visit . #Veravas #VeraBIND #BiomarkerDetection #EarlyDiseaseDetection #PrecisionMedicine #Diagnostics #Saliva #NonInvasiveTesting #Alzheimers #Celiac #Lyme #MatrixFreeSample #SampleInterferences #Home-Based Testing #ClinicalDiagnostics #ImprovedAccuracy #BiomarkerDetection #EnrichingBiomarkers #MoreSensitiveDetection #OralRinseCollection #Ultra-SensitiveAssays SOURCE Veravas, Inc.