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).

德克萨斯州奥斯汀——（商业新闻短讯）——临床诊断领域的领先创新者Veravas今天宣布了其VeraBIND™Tau分析的分析验证研究结果，这是一项与Phanes Biotech共同开发的下一代测试，Phanes Biotech是一家专注于神经退行性疾病治疗的早期生物技术公司，用于检测阿尔茨海默氏病（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..

该测试旨在检测和测量疾病病理，以便在最早，最可治疗的阶段诊断AD。与测量指示潜在疾病的生物标志物的第一代测试不同，VeraBIND Tau旨在通过研究大脑中过度磷酸化Tau（HPT）和正常Tau（nTau）之间发生的可测量结合活性来检测活动性疾病，这是AD的标志。该测试还可以帮助诊断AD，为临床医生提供Tau PET成像的可访问，准确且负担得起的替代方案。。

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.

AD是美国第六大死亡原因，估计有690万65岁或65岁以上的美国人患有AD。2,3临床医生必须有可用的工具来快速准确地诊断AD，并将其与其他导致认知障碍的痴呆区分开来，以实现有针对性的治疗。

In AD, lifestyle modifications and emerging tau-directed therapies have shown promise in slowing or delaying cognitive decline..

在AD中，生活方式的改变和新兴的tau导向疗法有望减缓或延缓认知能力的下降。。

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..

Veravas证明了VeraBIND Tau能够准确测量过度磷酸化Tau的病理活性。在这项分析验证研究中，对100例回顾性收集的患者样本进行了测试方案，其中52例通过F18MK6240 tau PET成像证实AD tau病理呈阳性（其中19例认知功能正常，21例轻度认知障碍，12例痴呆），38例健康对照，10例β淀粉样斑块阳性但tau PET阴性的患者。数据显示94.2%的敏感性和89.6%的特异性，导致总体VeraBIND tau检测与tau PET成像的一致性为92.0%。。

“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.

“这些分析数据表明，VeraBIND Tau可以测量患有和不患有认知障碍的个体中AD的活动性Tau病理学，”医学博士Bernard Hanseeuw说，他是比利时圣卢克大学医院神经内科记忆诊所副主任兼马萨诸塞州波士顿综合医院讲师。

“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”..

“这种测试的实施不仅可以在一天内加快AD的诊断速度，还可以用于指导tau导向疗法的开发和测试。它还对非AD tau蛋白病具有很大的希望，因为该检测方法在8例低淀粉样蛋白和阳性tau PET数据测试的病例中有7例呈阳性”。。

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.

为了共同开发VeraBIND Tau分析，这些公司使用了Veravas专有的VeraBIND技术，该平台旨在捕获和纯化血液中的关键蛋白质，以实现高度准确的蛋白质检测和表征。当与抗体结合时，VeraBIND磁性纳米珠可作为多种样品类型的过滤器，从而能够去除干扰物质，这些物质可能会掩盖感兴趣的生物标志物并可能产生错误的结果。

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..

这项专利技术使研究低丰度致病蛋白成为可能，否则可能无法通过富集预分析样品来检测，以提高分析物的可检测性。。

“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.”.

Veravas首席科学官乔什·索尔多（JoshSoldo）说：“这些结果表明，VeraBIND Tau具有变革潜力，可以颠覆疑似阿尔茨海默病患者管理的标准。”我们的高度准确的分析测试方案可以快速且经济高效地执行，并可能消除与生物标志物检测测试相关的不确定性以及与tau PET成像相关的高成本和等待时间，从而帮助临床医生更快地为患者提供答案。“。

“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.

Phanes Biotech首席科学官哈立德·伊克巴尔（KhalidIqbal）表示：“VeraBIND Tau检测将首次在无法进行Tau PET成像的地区诊断阿尔茨海默病。”。

For more information about the VeraBIND Tau assay and other VeraBIND products, visit www.veravas.com.

有关VeraBIND Tau分析和其他VeraBIND产品的更多信息，请访问www.veravas.com。

About Veravas

关于维拉瓦斯

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.

Veravas是临床诊断领域的领先创新者，专注于阿尔茨海默病和其他神经系统疾病的早期检测和预后筛查。该公司专有的VeraBIND™技术将具有挑战性的样本类型转化为可测量的生物标志物，从而实现早期疾病检测和新型诊断测试的开发。

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..

其VeraBIND Tau测定法是一流的基于血液的测试，可测量认知正常个体或经历认知障碍的个体的血液样本中过度磷酸化Tau的病理活性，可用于帮助诊断阿尔茨海默氏病。请访问Veravas.com了解更多信息，或在LinkedIn上关注我们。。

About Phanes Biotech

关于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.

Phanes Biotech是一家早期生物技术公司，专注于开发神经退行性疾病的突破性治疗方法，包括阿尔茨海默氏病，黄斑变性，创伤性脑损伤，中风，唐氏综合征相关阿尔茨海默氏病和认知衰老。Phanes对阿尔茨海默病和其他神经退行性疾病采取了独特而有区别的方法，使其与目前正在开发的现有疗法和药物不同。

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.

该公司的管道包括创新药物：（1）神经再生小分子P021-这种有前途的治疗方法旨在通过将平衡从神经退行性变为神经再生来解决阿尔茨海默病。（2） 。

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.

它是唯一显示可减少tau和Aβ病理的抗体。通过战略合作伙伴关系，Phanes利用其tau靶向抗体组合开发了一种开创性的，一流的基于血液的检测方法。这种创新的诊断工具旨在检测和测量大脑中的tau病理活动，为诊断和跟踪阿尔茨海默氏病的进展制定新标准。

Learn more at Phanesbiotech.com or follow us on LinkedIn..

请访问Phanesbiotech.com了解更多信息，或在LinkedIn上关注我们。。

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