BELLINGHAM, Wash., March 4, 2024 /PRNewswire/ -- Neurocode USA, Inc, a specialized clinical laboratory that offers world-class testing solutions for neurological disorders, is pleased to announce the clinical launch of ALZpath Dx, an innovative and novel blood test that can be used in the screening, diagnosis, and monitoring of Alzheimer's disease (AD) based on circulating level of pTau217 in the blood. Neurocode is the first laboratory in the United States to make this test available as a Laboratory Developed Test (LDT) for clinical diagnostic use, clinical trials and other research purposes..

华盛顿州贝林厄姆，2024年3月4日/PRNewswire/--Neurocode USA，Inc是一家专门的临床实验室，为神经系统疾病提供世界一流的测试解决方案，很高兴宣布ALZpath Dx的临床推出，这是一种创新的新型血液测试，可用于阿尔茨海默氏病（AD）的筛查，诊断和监测基于血液中pTau217的循环水平。Neurocode是美国第一个将此测试作为实验室开发的测试（LDT）用于临床诊断用途，临床试验和其他研究目的的实验室。。

Neurocode's new blood test is as accurate as brain imaging or CSF testing for diagnosing Alzheimer's, but is faster, more accessible, less expensive, and less invasive.

Neurocode的新血液检测与脑成像或脑脊液检测诊断阿尔茨海默病一样准确，但更快，更容易获得，更便宜，侵入性更小。

Neurocode's pioneering assay measures levels of phosphorylated tau at position 217 (pTau217). pTau217 is widely considered to be the leading transformative blood-based biomarker that will enable earlier and more accurate AD diagnosis, better stratification of patients for clinical trials, improved patient care and treatment, and greater diagnostic specificity and sensitivity than other blood-based biomarkers.

Neurocode的开创性测定法测量了217位（pTau217）磷酸化tau的水平。pTau217被广泛认为是领先的基于血液的生物标志物，与其他基于血液的生物标志物相比，它可以实现更早和更准确的AD诊断，更好的临床试验患者分层，改善患者护理和治疗，以及更高的诊断特异性和敏感性。

The test is powered by the Simoa ® (single-molecule assay) technology of Quanterix Corp. .

该测试由Quanterix Corp.的Simoa®（单分子测定）技术提供支持。

'The clinical availability of the ALZpath Dx test is significant as it provides a more scalable, more accessible, and less invasive option for the diagnosis of patients in earlier stages of the disease, when recently-approved disease-modifying therapies are most beneficial. Patients and their families gain unprecedented ease of access to early and accurate diagnosis and the opportunity for timely treatment,' said Ryan Fortna, MD PhD, Medical Director of Neurocode.

“ALZpath Dx测试的临床可用性非常重要，因为它为疾病早期阶段的患者诊断提供了一种更具可扩展性，更容易获得且侵入性更小的选择，而最近批准的疾病缓解疗法最为有益。Neurocode医学总监Ryan Fortna博士说，患者及其家属获得了前所未有的早期准确诊断和及时治疗的机会。

'Additionally, this blood-based test is as accurate as brain imaging or CSF testing, but is faster, more accessible, less expensive, and less invasive, and it does not require radiation exposure.'.

“此外，这种基于血液的测试与大脑成像或脑脊液测试一样准确，但速度更快，更容易获得，成本更低，侵入性更小，并且不需要辐射暴露。”。

Recently, ALZpath announced results of an international peer-reviewed study published in JAMA Neurology, evaluating the performance of its ALZpath Dx assay in a 786-patient study. The findings demonstrated that the ultra-sensitive immunoassay showed high diagnostic accuracy in identifying elevated amyloid in the brain across all cohorts.

最近，ALZpath宣布了发表在JAMA Neurology上的一项国际同行评审研究的结果，该研究评估了其ALZpath Dx分析在786名患者研究中的表现。研究结果表明，超灵敏免疫测定法在识别所有队列中大脑中淀粉样蛋白升高方面显示出很高的诊断准确性。

The accuracy was significantly higher than other blood-based biomarker combinations and equivalent to cerebrospinal fluid (spinal tap) biomarkers. It demonstrated high accuracy in predicting AD brain pathologies (amyloid-beta plaques and tau tangles) as identified by positron emission tomography (PET) imaging, the current gold standard diagnostic technique..

准确性显着高于其他基于血液的生物标志物组合，相当于脑脊液（脊髓tap）生物标志物。正电子发射断层扫描（PET）成像是目前的金标准诊断技术，它在预测AD脑部病变（淀粉样β斑块和tau缠结）方面具有很高的准确性。。

Neurocode is the first laboratory in the world to offer the ALZpath Dx test for clinical use within a CAP-accredited, CLIA-certified facility. Their validation study used over 1,700 samples with amyloid PET imaging and 150 subjects with post-mortem (autopsy) pathology, demonstrating an area under the curve (AUC) of 0.94, significantly exceeding the 90% accuracy threshold for a standalone diagnostic AD test proposed by the Alzheimer's Association Workgroup in their 2023 draft proposal for the Revised Criteria for Diagnosis and Staging of Alzheimer's Disease..

Neurocode是世界上第一个在CAP认证的CLIA认证设施内提供ALZpath Dx测试用于临床的实验室。他们的验证研究使用了1700多个淀粉样蛋白PET成像样本和150名验尸（尸检）病理受试者，证明曲线下面积（AUC）为0.94，大大超过了阿尔茨海默病协会工作组在2023年修订的阿尔茨海默病诊断和分期标准草案中提出的独立诊断性AD测试的90%准确率阈值。。

Andreas Jeromin, PhD, Chief Scientific Officer of ALZpath, said, 'The availability of ALZpath Dx in our first partner laboratory marks a significant milestone in making this test available for clinical use, and we are thrilled to collaborate with Neurocode. Looking ahead, ALZpath is planning to expand our network to help patients, their families, health care providers and pharmaceutical/biotech companies, and to improve care and management of a disease that devastates so many lives.'.

ALZpath首席科学官Andreas Jeromin博士说，“我们的第一个合作伙伴实验室提供了ALZpath Dx，这标志着该测试可用于临床的重要里程碑，我们很高兴与Neurocode合作。展望未来，ALZpath正计划扩大我们的网络，以帮助患者及其家人、医疗保健提供者和制药/生物技术公司，并改善对这种摧毁众多生命的疾病的护理和管理。”。

The test must be ordered by a healthcare provider. Sample collection kits are provided to facilitate blood collection and shipping to Neurocode by an affiliated phlebotomy site. Information about ordering, sample collections and shipping requirements can be found on their website.

测试必须由医疗保健提供者订购。提供样品采集套件以便于血液采集和通过附属静脉切开术部位运送到Neurocode。有关订购、样品收集和装运要求的信息可以在他们的网站上找到。

About Neurocode

关于神经代码

Neurocode is a clinical laboratory that offers novel and innovative FDA-approved, and laboratory-developed tests, specializing in neurodegeneration and neuroimmunology biomarkers for clinical and research use. They work closely with researchers to advance the field of AD diagnostics and perform thorough validations of  novel biomarkers to empower clinicians to make informed decisions.

Neurocode是一家临床实验室，提供FDA批准的新颖创新的实验室开发测试，专门用于临床和研究用途的神经退行性疾病和神经免疫学生物标志物。他们与研究人员密切合作，推进AD诊断领域，并对新型生物标志物进行彻底验证，以使临床医生能够做出明智的决定。

To learn more about accessing the ALZpath Dx test and Neurocode's full range of diagnostic solutions, please visit neurocode.com or contact us below..

要了解有关访问ALZpath Dx测试和Neurocode全套诊断解决方案的更多信息，请访问Neurocode.com或与我们联系。。

About ALZpath

关于ALZpath

ALZpath is a leading provider of innovative diagnostic solutions for Alzheimer's disease and related dementias. The novel ALZpath Dx assay is transforming Alzheimer's disease diagnosis and treatment monitoring, providing more accurate and accessible tools for clinicals and researchers worldwide. To learn more about the company, please visit alzpath.bio..

ALZpath是阿尔茨海默病和相关痴呆症创新诊断解决方案的领先供应商。新型ALZpath Dx分析正在改变阿尔茨海默氏病的诊断和治疗监测，为全球临床和研究人员提供更准确和可访问的工具。要了解更多有关该公司的信息，请访问alzpath.bio。。

Neurocode contact:

神经代码联系人：

Michael Metke

Michael Metke

Neurocode Medical Science Liaison

神经代码医学联络

CustomerCare@neurocode.com

CustomerCare@neurocode.com

+1 425 312 3791

+1 425 312 3791

ALZpath contact:

ALZpath联系人：

Andreas Jeromin, PhD

Andreas Jeromin，博士

ALZpath Chief Scientific Officer

ALZpath首席科学官

andreas@alzpath.bio

andreas@alzpath.bio

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SOURCE Neurocode Labs

源神经代码实验室