A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States

The goal of this study is to evaluate whether use of the PrecivityAD2 blood biomarker assay with early result disclosure along with discretionary Precivity-ApoE proteotype testing will shorten the time to Alzheimer's Disease or non-Alzheimer's diagnosis as compared to delayed result disclosure.
Participants will be randomized into the early PrecivityAD2 blood biomarker test & disclosure group (Cohort A) or to the later PrecivityAD2 blood biomarker test & disclosure group (Cohort B) where blood samples will be collected and tested using the PrecivityAD2 test at Visit 1 (day 0) and Visit 2 (day 90). Participants will attend study visits for one year after their enrollment. An optional sub-study will be offered to collect information through questionnaires at each visit regarding participant's and their care-giver's experiences through the AD diagnostic journey.

开始日期2025-07-01

申办/合作机构

C2N Diagnostics LLC

[+1]

NCT07041450

/ RecruitingN/AIIT

A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers

This study evaluates a diagnostic screening solution for Alzheimer's disease (AD) using digital cognitive assessments and blood-based biomarkers. The aim is to reduce time-to-treatment for patients who may benefit from disease-modifying therapy (DMT). The study involves 500 patients referred to the MoCA Clinic in Montreal. Clinical stages will be assessed using digital tools from MoCA Test Inc. (MoCA Cognition), and biological stages via blood biomarkers. Data collected includes demographics, cognitive scores, health questionnaires, biomarker levels, and neurologist-determined eligibility for DMT. The study will result in an algorithm to support diagnostic triage and estimate the efficiency and equity of a fast-track diagnostic pathway. Exploratory endpoints include validation of self-administered digital tools, health-economic estimates, and predictors of cognitive decline.

开始日期2025-03-14

申办/合作机构

C2N Diagnostics LLC

NCT06025877

/ Active, not recruitingN/A

Quality Improvement PrecivityAD2(TM): A Survey and Clinical Utility Study of the PrecivityAD2 Blood Test in the Evaluation of Cognitive Impairment (QUIP II)

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022).

开始日期2023-11-15

申办/合作机构

C2N Diagnostics LLC

100 项与 C2N Diagnostics LLC 相关的临床结果

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项与 C2N Diagnostics LLC 相关的文献（医药）

2025-12-01·NATURE MEDICINE

Primary care detection of Alzheimer’s disease using a self-administered digital cognitive test and blood biomarkers

Article

作者: Strandberg, Olof ; Braunstein, Joel B ; Smith, Ruben ; Midlöv, Patrik ; Palmqvist, Sebastian ; Tideman, Pontus ; Verghese, Philip B ; Mattsson-Carlgren, Niklas ; Calling, Susanna ; Hansson, Oskar ; Stomrud, Erik ; Karlsson, Linda

Abstract:

After the clinical implementation of amyloid-β-targeting therapies for people with cognitive impairment due to Alzheimer’s disease (AD), there is an urgent need to efficiently identify this patient population in primary care. Therefore, we created a brief and self-administered digital cognitive test battery (BioCog). Based on its sub-scores, a logistic regression model was developed in a secondary care cohort ( n = 223) and then evaluated in an independent primary care cohort comprising 19 primary care centers ( n = 403). In primary care, BioCog had an accuracy of 85% when using a single cutoff to define cognitive impairment, which was significantly better than the assessment of primary care physicians (accuracy 73%). The accuracy increased to 90% when using a two-cutoff approach. BioCog had significantly higher accuracy than standard paper-and-pencil tests (that is, Mini-Mental State Examination, Montreal Cognitive Assessment, Mini-Cog) and another digital cognitive test. Furthermore, BioCog combined with a blood test could detect clinical, biomarker-verified AD with an accuracy of 90% (one cutoff), significantly better than standard-of-care (accuracy 70%) or when using the blood test alone (accuracy 80%). In conclusion, this proof-of-concept study shows that a brief, self-administered digital cognitive test battery can detect cognitive impairment and, when combined with a blood test, accurately identify clinical AD in primary care.

2024-10-15·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Blood Biomarkers to Detect Alzheimer Disease in Primary Care and Secondary Care

Article

作者: Stomrud, Erik ; Smith, Ruben ; Braunstein, Joel B. ; Tideman, Pontus ; Janelidze, Shorena ; Blennow, Kaj ; West, Tim ; Schindler, Suzanne E. ; Hansson, Oskar ; Monane, Mark ; Mattsson-Carlgren, Niklas ; Salvadó, Gemma ; Palmqvist, Sebastian ; Verghese, Philip B. ; Ossenkoppele, Rik ; Calling, Susanna

Importance:

An accurate blood test for Alzheimer disease (AD) could streamline the diagnostic workup and treatment of AD.

Objective:

To prospectively evaluate a clinically available AD blood test in primary care and secondary care using predefined biomarker cutoff values.

Design, Setting, and Participants:

There were 1213 patients undergoing clinical evaluation due to cognitive symptoms who were examined between February 2020 and January 2024 in Sweden. The biomarker cutoff values had been established in an independent cohort and were applied to a primary care cohort (n = 307) and a secondary care cohort (n = 300); 1 plasma sample per patient was analyzed as part of a single batch for each cohort. The blood test was then evaluated prospectively in the primary care cohort (n = 208) and in the secondary care cohort (n = 398); 1 plasma sample per patient was sent for analysis within 2 weeks of collection.

Exposure:

Blood tests based on plasma analyses by mass spectrometry to determine the ratio of plasma phosphorylated tau 217 (p-tau217) to non–p-tau217 (expressed as percentage of p-tau217) alone and when combined with the amyloid-β 42 and amyloid-β 40 (Aβ42:Aβ40) plasma ratio (the amyloid probability score 2 [APS2]).

Main Outcomes and Measures:

The primary outcome was AD pathology (determined by abnormal cerebrospinal fluid Aβ42:Aβ40 ratio and p-tau217). The secondary outcome was clinical AD. The positive predictive value (PPV), negative predictive value (NPV), diagnostic accuracy, and area under the curve (AUC) values were calculated.

Results:

The mean age was 74.2 years (SD, 8.3 years), 48% were women, 23% had subjective cognitive decline, 44% had mild cognitive impairment, and 33% had dementia. In both the primary care and secondary care assessments, 50% of patients had AD pathology. When the plasma samples were analyzed in a single batch in the primary care cohort, the AUC was 0.97 (95% CI, 0.95-0.99) when the APS2 was used, the PPV was 91% (95% CI, 87%-96%), and the NPV was 92% (95% CI, 87%-96%); in the secondary care cohort, the AUC was 0.96 (95% CI, 0.94-0.98) when the APS2 was used, the PPV was 88% (95% CI, 83%-93%), and the NPV was 87% (95% CI, 82%-93%). When the plasma samples were analyzed prospectively (biweekly) in the primary care cohort, the AUC was 0.96 (95% CI, 0.94-0.98) when the APS2 was used, the PPV was 88% (95% CI, 81%-94%), and the NPV was 90% (95% CI, 84%-96%); in the secondary care cohort, the AUC was 0.97 (95% CI, 0.95-0.98) when the APS2 was used, the PPV was 91% (95% CI, 87%-95%), and the NPV was 91% (95% CI, 87%-95%). The diagnostic accuracy was high in the 4 cohorts (range, 88%-92%). Primary care physicians had a diagnostic accuracy of 61% (95% CI, 53%-69%) for identifying clinical AD after clinical examination, cognitive testing, and a computed tomographic scan vs 91% (95% CI, 86%-96%) using the APS2. Dementia specialists had a diagnostic accuracy of 73% (95% CI, 68%-79%) vs 91% (95% CI, 88%-95%) using the APS2. In the overall population, the diagnostic accuracy using the APS2 (90% [95% CI, 88%-92%]) was not different from the diagnostic accuracy using the percentage of p-tau217 alone (90% [95% CI, 88%-91%]).

Conclusions and Relevance:

The APS2 and percentage of p-tau217 alone had high diagnostic accuracy for identifying AD among individuals with cognitive symptoms in primary and secondary care using predefined cutoff values. Future studies should evaluate how the use of blood tests for these biomarkers influences clinical care.

2014-12-24·Science translational medicine1区 · 医学

Reply to comment on “An antidepressant decreases CSF Aβ production in healthy individuals and in transgenic AD mice”

1区 · 医学

Letter

作者: Morris, John C. ; Yarasheski, Kevin ; Frederiksen, Christine ; Xiong, Chengjie ; Bateman, Randall J. ; Hettinger, Jane C. ; Grzelak, Monica V. ; Cirrito, John R. ; Jasielec, Mateusz S. ; West, Tim ; Lee, Jin-Moo ; Tripoli, Danielle L. ; Sheline, Yvette I.

Possible reasons for why a new study could not replicate our finding that the serotonin reuptake inhibitor citalopram decreased amyloid β concentrations in the cerebrospinal fluid of healthy volunteers.

项与 C2N Diagnostics LLC 相关的新闻（医药）

2025-12-17

·阿尔茨海默病研究

pTau217谁是诊断"金标准"？西门子、罗氏、贝克曼、quanterix全用ALZpath抗体

关键词:阿尔茨海默病、磷酸化tau蛋白217、血液生物标志物、体外诊断、抗体标准化Keyword: Alzheimer's disease, phosphorylated tau 217, blood-based biomarkers, in vitro diagnostics, antibody standardization新闻发生时间: 2025年1月ALZpath与西门子医疗合作,推动pTau217血液检测全球化ALZpath公司近日宣布与西门子医疗(Siemens Healthineers)达成一项战略许可协议,将其专有的pTau217(磷酸化tau蛋白217位点)抗体整合至西门子Atellica免疫分析系统,用于开发新一代阿尔茨海默病(AD)体外诊断检测项目[①][②]。根据协议条款,西门子医疗将在其不断扩展的AD体外诊断检测菜单中新增pTau217检测项目,使临床实验室能够通过简单的抽血实现基于血液的神经退行性疾病检测,这标志着AD诊断从依赖脑脊液穿刺和昂贵的PET成像向更便捷、经济的血液检测方式转变迈出关键一步[③]。pTau217作为血液生物标志物,在检测AD病理方面表现出与PET成像和脑脊液检测相当的性能[④]。研究显示,pTau217能够准确反映大脑中淀粉样蛋白(Aβ)和tau蛋白病理变化,甚至在临床症状出现前数年即可检测到异常,为早期干预提供了宝贵的时间窗口[⑤][⑥]。随着礼来多纳单抗(Donanemab)、卫材仑卡奈单抗(Lecanemab)等疾病修饰疗法获批,精准识别淀粉样蛋白阳性患者的需求急剧增加,血液检测正成为临床实践中不可或缺的工具[⑦]。pTau217抗体供应格局:ALZpath占据核心地位 pTau217抗体来源与标准化列表值得关注的是,ALZpath的专利pTau217抗体已成为全球主流诊断平台的首选试剂。除西门子医疗外,罗氏诊断(Roche Diagnostics)于2024年6月宣布与ALZpath签署许可协议,将该抗体应用于其诊断平台开发AD血液检测项目[⑧][⑨]。同年7月,贝克曼库尔特诊断(Beckman Coulter Diagnostics)也与ALZpath达成合作,利用其抗体开发高通量pTau217检测试剂盒[10][11]。Quanterix公司则将ALZpath抗体整合至其超灵敏Simoa平台,推出商业化的pTau217检测试剂盒,并授权ARUP等大型参考实验室使用[12][13]。这一现象凸显了ALZpath在pTau217抗体领域的技术优势。该公司开发的专有单克隆抗体采用特异性捕获pTau217表位的设计,配合N端检测抗体,在多项头对头比较研究中展现出优异的分析性能和诊断准确性[14][15]。相比之下,礼来公司开发的IBA493抗体虽然在早期研究中广泛应用,但主要局限于研究用途,其商业化进程相对滞后[16][17]。Quanterix的数据显示,基于ALZpath抗体的Simoa检测平台灵敏度可达飞摩尔级别,能够在健康对照组和AD患者之间实现清晰区分[18]。Lumipulse平台与抗体来源日本富士胶片富山化学(Fujirebio)的Lumipulse系统是另一主要pTau217检测平台。2025年5月,其Lumipulse G pTau 217/β-淀粉样蛋白1-42比值检测成为首个获得FDA批准的血液AD诊断项目[19][20]。根据公开资料,Lumipulse平台使用的pTau217抗体由Fujirebio自主开发,采用化学发光酶免疫分析(CLEIA)技术,与ALZpath抗体在技术路线上存在差异[21][22]。临床研究显示,Lumipulse pTau217检测与基于ALZpath抗体的其他平台(如Simoa)具有良好的相关性,但在某些队列中存在绝对浓度值的差异,提示不同抗体克隆可能影响检测结果的可比性[23][24]。C2N Diagnostics的PrecivityAD2检测则采用独特的质谱技术路径,通过免疫沉淀结合液相色谱-串联质谱(LC-MS/MS)定量pTau217,而非传统免疫分析方法[25][26]。这种技术具有高特异性和抗干扰能力,但设备成本和操作复杂度限制了其在基层医疗机构的推广[27]。抗体标准化挑战与未来展望尽管pTau217检测展现出巨大潜力,但不同平台间的标准化问题仍是当前面临的主要挑战。一项涵盖多个pTau217免疫分析的比较研究指出,由于抗体克隆、检测平台和校准品的差异,不同检测系统报告的绝对浓度值难以直接比较[28][29]。研究者呼吁建立国际统一的参考标准物质和校准程序,以确保检测结果在不同实验室间的一致性[30][31]。从市场格局来看,ALZpath抗体的广泛授权有助于推动检测标准化进程。当多个主流平台采用相同抗体时,结果可比性将显著提升,这对于建立临床决策阈值、支持药物研发和真实世界研究至关重要[32]。西门子医疗此次引入ALZpath抗体,将使其Atellica系统与罗氏、贝克曼和Quanterix等平台形成"抗体统一战线",为全球AD血液检测的规模化应用奠定基础[33]。随着血液生物标志物检测逐步纳入临床指南,pTau217检测有望在未来几年内成为AD诊断工作流程的核心组成部分[34]。业内专家预计,到2030年,基于pTau217的血液检测市场规模将达到数十亿美元,而抗体标准化和平台互操作性将成为决定市场竞争格局的关键因素[35]。---前期新闻回顾:- 2024年6月,ALZpath与罗氏诊断签署许可协议,标志着其抗体技术首次进入大型诊断企业平台[⑧](https://www.researchsquare.com/article/rs-6153769/v1.pdf?c=1745829318000)。- 2024年7月,贝克曼库尔特宣布推出基于ALZpath抗体的研究用试剂盒(RUO),用于高通量实验室检测[11]。- 2025年5月,Fujirebio的Lumipulse pTau217比值检测获FDA批准,成为首个获批的血液AD诊断产品[19]。- Quanterix与礼来合作,授权ARUP等实验室使用其Simoa平台(基于礼来IBA493抗体)进行临床检测[13]。---ALZpath公司:总部位于美国的生物技术公司,专注于开发AD早期检测技术。其专有的pTau217抗体技术源自哥德堡大学(University of Gothenburg)等机构的研究成果,已授权全球多家诊断巨头使用[36][37]。公司联合创始人包括Banner阿尔茨海默研究所CEO Eric Reiman博士等知名科学家[38]。西门子医疗(Siemens Healthineers):全球领先的医疗技术公司,其Atellica免疫分析系统广泛应用于临床实验室。此次合作将增强其在神经退行性疾病诊断领域的产品组合[②]。罗氏诊断(Roche Diagnostics):体外诊断领域全球领导者,与礼来合作推进AD血液检测的临床应用,并与ALZpath合作开发基于pTau217的检测项目[⑧][⑨]。贝克曼库尔特诊断(Beckman Coulter Diagnostics):丹纳赫(Danaher)旗下公司,专注于高通量临床检测系统,其基于ALZpath抗体的pTau217试剂盒已用于研究和药物开发[10][11]。Quanterix:超灵敏免疫分析技术领导者,其Simoa平台能够检测极低浓度的血液生物标志物,是pTau217检测的重要平台之一[12][13]。Fujirebio:富士胶片旗下诊断公司,其Lumipulse系统是首个获FDA批准的血液AD诊断平台,采用自主开发的pTau217抗体[19][20]。C2N Diagnostics:华盛顿大学医学院衍生公司,开发基于质谱技术的PrecivityAD系列血液检测,采用不依赖单一抗体的技术路线[25][26]。参考文献 [①](https://kdvr.com/business/press-releases/cision/20250325IO49137/alzpath-adds-biotech-veteran-to-board-of-directors-and-names-prominent-global-researcher-as-distinguished-scientific-advisor/) PR Newswire. "ALZpath and Siemens Healthineers Sign Licensing Agreement to Advance Global Access to Blood-Based Alzheimer's Disease Diagnostic Testing." 2025. https://www.prnewswire.com/news-releases/alzpath-and-siemens-healthineers-sign-licensing-agreement-to-advance-global-access-to-blood-based-alzheimers-disease-diagnostic-testing-302642172.html[②](https://globalnews.ca/news/10244014/alzheimers-disease-study-blood-test/) FierceBiotech. "Siemens Healthineers taps ALZpath for Alzheimer's blood test biomarker." 2025. https://www.fiercebiotech.com/medtech/siemens-healthineers-taps-alzpath-alzheimers-blood-test-biomarker[③](https://pmc.ncbi.nlm.nih.gov/articles/PMC11567841/) CLPMAG. "ALZpath, Siemens Healthineers Partner on Blood-Based Alzheimer's Testing." 2025. https://clpmag.com/disease-states/dementias-alzheimer/alzpath-siemens-healthineers-partner-blood-based-alzheimers-testing/[④](https://www.medrxiv.org/content/10.1101/2025.07.22.25331791v1) Longevity Technology. "New deal to expand access to blood-based Alzheimer's testing." 2025. https://longevity.technology/news/new-deal-to-expand-access-to-blood-based-alzheimers-testing/[⑤](https://www.brightfocus.org/resource/alzheimers-blood-tests-how-do-they-work-and-should-you-request-one/) Janelidze S et al. "A comparison of p‐tau assays for the specificity to detect tau pathology in Alzheimer's disease." Alzheimer's & Dementia, 2025. doi:10.1002/alz.70208[⑥](https://synapse.patsnap.com/organization/af6ec40343b6791511cd3f3a6bd51c47) Wojdała AL et al. "Analytical and clinical performance of eight Simoa® and Lumipulse® immunoassays for plasma p-tau isoforms." Alzheimer's & Dementia, 2024. PMC11660642[⑦](https://alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.13525) Alzheimer's Association. "Clinical Practice Guideline on the use of blood-based biomarkers in the diagnostic workup of suspected Alzheimer's disease." 2025.[⑧](https://www.researchsquare.com/article/rs-6153769/v1.pdf?c=1745829318000) PR Newswire. "ALZpath Announces Licensing Agreement with Roche for Use of ALZpath's Proprietary pTau217 Antibody in Blood Test to Diagnose Alzheimer's Disease." June 10, 2024. https://www.prnewswire.com/news-releases/alzpath-announces-licensing-agreement-with-roche-for-use-of-alzpaths-proprietary-ptau217-antibody-in-blood-test-to-diagnose-alzheimers-disease-302168168.html[⑨](https://pmc.ncbi.nlm.nih.gov/articles/PMC11175644/) PharmaPhoruma. "ALZpath licenses Alzheimer's diagnosis tech to Roche." 2024. https://pharmaphorum.com/news/alzpath-licenses-alzheimers-diagnosis-tech-roche[10] ALZpath. "ALZpath Signs Licensing Agreement with Beckman Coulter Diagnostics." July 15, 2024. https://alzpath.bio/july-15-2024-press-release-alzpath-beckman-coulter-partnership/[11] Beckman Coulter. "Beckman Coulter Introduces Cutting-Edge Research Use Only Assays for Neurodegenerative Disease." January 2025. https://www.beckmancoulter.com/about-beckman-coulter/newsroom/press-releases/2025/q1/2025-jan15-bec-introduces-cutting-edge-neurodegenerative-ruo-assays[12] Quanterix. "p-Tau 217 (Simoa® ALZpath) Assay." https://www.quanterix.com/simoa-assay-kits/simoa-alzpath-p-tau-217-assay/[13] Quanterix. "Quanterix Announces New Agreement to Advance Blood-Based Alzheimer's Disease Detection." https://www.quanterix.com/press-releases/quanterix-announces-new-agreement-to-advance-blood-based-alzheimers-disease-detection/[14] Pilotto A et al. "Plasma p-tau217 in Alzheimer's disease: Lumipulse and Simoa assays." Brain, vol. 148, no. 2, 2025, pp. 408. doi:10.1093/brain/awae419[15] Sehrawat A et al. "Pittsburgh plasma p-tau217." medRxiv, 2025. doi:10.1101/2025.05.03.25326526[16] Bayoumy S et al. "Clinical and analytical comparison of six Simoa assays for plasma P-tau isoforms." Alzheimer's Research & Therapy, vol. 13, 2021. PMC8645090[17] Thijssen EH et al. "Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer's disease and frontotemporal lobar degeneration." JAMA Neurology, 2021.[18] Mammel AE et al. "Clinical decision points for two plasma p‐tau217 laboratory‐developed tests." Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, 2025. doi:10.1002/dad2.70070[19] Fujirebio. "Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio." May 2025. https://www.fujirebio.com/en-us/news-events/fujirebio-receives-marketing-clearance-for-lumipulser-g-ptau-217bamyloid-142-plasma-0[20] Quest Diagnostics. "Quest Diagnostics to Offer FDA-Cleared Fujirebio Blood Test for Alzheimer's Disease." 2025. https://ir.questdiagnostics.com/press-releases/press-release-details/2025/Quest-Diagnostics-to-Offer-FDA-Cleared-Fujirebio-Blood-Test-for-Alzheimers-Disease/default.aspx[21] Fujirebio. "Lumipulse® G pTau 217 Plasma." https://www.fujirebio.com/en/products-solutions/lumipulse-g-ptau-217-plasma[22] FDA. "510(k) Clearance Letter for Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio." K242706, May 16, 2025. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242706.pdf[23] Palmqvist S et al. "Plasma phospho-tau217 for Alzheimer's disease diagnosis with a fully automated assay." Nature Medicine, 2025. doi:10.1038/s41591-025-03622-w[24] Warmenhoven N et al. "A comprehensive head-to-head comparison of key plasma phospho-tau217 biomarker tests." Brain, vol. 148, no. 2, 2025, pp. 416. doi:10.1093/brain/awae301[25] Meyer MR et al. "Clinical validation of the PrecivityAD2 blood test." Alzheimer's & Dementia, 2024. PMC11095426[26] Medical News Today. "Alzheimer's: New blood test may help catch 90% of cases." 2024. https://www.medicalnewstoday.com/articles/blood-test-shows-90-accuracy-identifying-alzheimers-disease[27] MDPI. "Implementation of an Alzheimer's Disease Blood Test in Clinical Practice." Personalized Medicine, vol. 15, no. 10, 2025.[28] Arslan B et al. "Comparative analysis of plasma p-tau217 immunoassays: challenges for standardization and harmonization." Clinical Chemistry and Laboratory Medicine, 2025. doi:10.1515/cclm-2025-1192[29] Verberk IMW et al. "Evidence‐based standardized sample handling protocol for plasma p‐tau biomarkers." Alzheimer's & Dementia, 2025. PMC12481164[30] Teunissen CE et al. "Plasma p‐tau immunoassays in clinical research for Alzheimer's disease: A practical review." Alzheimer's & Dementia, 2025. doi:10.1002/alz.14397[31] Ashton NJ et al. "The Alzheimer's Association Global Biomarker Standardization Consortium Round Robin study of plasma phospho-tau 217." Alzheimer's & Dementia, 2025. doi:10.1002/alz.14508[32] González-Ortiz F et al. "A novel ultrasensitive assay for plasma p‐tau217." Alzheimer's & Dementia, 2024. doi:10.1002/alz.13525[33] Drug Development & Delivery. "ALZpath: A Diagnostic Assay Changing the Future of Alzheimer's Disease." 2024. https://drug-dev.com/executive-interview-alzpath-a-diagnostic-assay-changing-the-future-of-alzheimers-disease/[34] Schöll M et al. "Challenges in the practical implementation of blood biomarkers for Alzheimer's disease." The Lancet Healthy Longevity, 2024. doi:10.1016/S2666-7568(24)00148-X[35] Dark Daily. "In Vitro Diagnostics Companies Race to Develop Blood-Based Tests for Alzheimer's Disease." August 16, 2024. https://www.darkdaily.com/2024/08/16/in-vitro-diagnostics-companies-race-to-develop-blood-based-tests-for-alzheimers-disease-data-suggest-a-worldwide-growing-market/[36] ALZpath. "ALZpath | Early and Accurate Alzheimer's Disease Detection." https://alzpath.bio/[37] TIME. "ALZpath pTau217 Antibody: the 200 Best Inventions of 2024." https://time.com/7094900/alzpath-ptau217-antibody/[38] KDVR. "ALZpath Adds Biotech Veteran to Board of Directors." March 25, 2025. https://kdvr.com/business/press-releases/cision/20250325IO49137/alzpath-adds-biotech-veteran-to-board-of-directors-and-names-prominent-global-researcher-as-distinguished-scientific-advisor/ 本文内容来自公开信息及研究文献，不代表临床建议。如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）

诊断试剂

2025-12-03

·高投毅达研究院

国家发改委积极推动基础设施REITs进一步扩围；芯感一体第三代电子皮肤产品发布

概要【政策风向】 · 国家发展改革委：积极推动基础设施REITs进一步扩围 · 股份行AIC：加速打通股权投资通道 · 中基协：公募基金规模逼近三十七万亿元 · 统计局：11月制造业PMI回升 · 趋势解读：国资央企向“新”并购的三重逻辑【行业观察】 · 中核集团：《核技术应用产业链强链行动计划》发布 · 北京：加速布局太空数据中心 · 美国：第二轮医保谈判结果公布 · 国际能源署：电气化进程重塑世界能源版图 · 阿尔茨海默病：疾病修饰疗法破局，开启早筛市场新纪元【企业动态】 · 万有引力：推出中国首颗5nm MR芯片 · 福莱新材：发布芯感一体第三代电子皮肤产品 · 阿科玛：与惠普推出新一代3D打印材料HR PA11 Gen2 · Tachyum：发布开源TDIMM内存标准 · IgA肾病：全球首个靶向APRIL单抗疗法获批上市政策风向重要资讯 1．国家发展改革委：积极推动基础设施REITs进一步扩围近日，国家发展改革委政策研究室副主任、新闻发言人李超在国家发展改革委11月份新闻发布会上表示，近期，国家发展改革委正在积极推动基础设施REITs进一步扩围至城市更新设施、酒店、体育场馆、商业办公设施等更多行业领域和资产类型。在基础设施REITs工作开展初期，将仓储物流、收费公路、市政设施、产业园区等纳入发行范围；后续，又逐步增加了清洁能源、数据中心、保障性租赁住房、水利设施、文化旅游、消费基础设施等行业领域和资产类型。目前，基础设施REITs发行范围已涵盖了12大行业的52个资产类型，其中，10个行业领域的18个资产类型已经实现了首单发行上市。（来源：证券日报） 2．股份行AIC：加速打通股权投资通道今年以来，股份制银行在AIC布局上明显提速。继五家国有大行之后，兴业银行、中信银行、招商银行三家股份行以及邮储银行旗下AIC相继获批筹建，四家机构注册资本均达百亿级别，分别为100亿元、100亿元、150亿元和100亿元。AIC作为商业银行开展市场化债转股和股权投资的重要载体，它的布局进展一直受到市场关注。今年以来，随着监管层持续完善制度体系、强化长期资本供给，大型与股份制银行在股权投资领域的动作明显加快。（来源：证券时报） 3．中基协：公募基金规模逼近三十七万亿元据中基协最新数据，截至2025年10月底，我国境内公募基金管理机构共165家，其中基金管理公司150家，取得公募资格的资产管理机构15家。以上机构管理的公募基金资产净值合计36.96万亿元，与9月底相比，单月规模增长2,182.74亿元，已经连续7个月创下历史新高。10月份，货币基金担纲公募规模增长的主力，在收益率持续走低的背景下，单月规模依旧上涨3,855.36亿元；此外QDII基金无论是净值还是规模均有显著增长；在权益市场震荡的背景下，权益基金整体规模则有所下滑；债基由于被多类机构减持，单月规模降幅超过1,000亿元。（来源：证券时报） 4．统计局：11月制造业PMI回升国家统计局服务业调查中心和中国物流与采购联合会发布的数据显示，11月，制造业采购经理指数（PMI）为49.2%，比10月上升0.2个百分点。其中，新出口订单回升提振制造业，特别是拉动中小企业景气度改善；受年底重点项目加快推进影响，建筑业景气度回升。11月，制造业景气度小幅回升，市场信心有所改善，但三大PMI指数仍位于荣枯线以下，应加大宏观政策实施力度，推动全年经济平稳收官。（来源：上海证券报）院研观点 5．趋势解读：国资央企向“新”并购的三重逻辑近日，国务院国资委组织召开中央企业专业化整合推进会，会议强调，国资央企要增强战略性新兴产业整合能力，同时提出要多用、善用资本市场。宏观层面，这是锚定国有资产保值增值的战略使命。中央企业作为国民经济“压舱石”，发展质量直接关系国有资产安全，更承载着服务国家战略、稳固经济大盘的重任。目前，中央企业面临一些现实挑战：一方面，国内传统产业供需错配、同质化竞争加剧；另一方面，在国际竞争中，部分核心技术仍受制于人。聚焦科技含量高、增长潜力大的战略性新兴产业，推动国有资本向产业链高端集中，这既破解“卡脖子”风险，也筑牢企业增值根基。中观层面，这有助于打通“科技—资本—产业”的正向循环生态。在这一循环中，中央企业通过加大研发投入，攻克关键领域核心技术，形成可产业化的科技成果；资本市场风险共担、利益共享的激励机制，为其提供从风险投资到上市融资、并购重组的全链条服务，为技术落地和产业扩张提供“耐心资本”。这种“科技突破—资本赋能—产业升级”的良性循环，形成三者相互促进的生态格局。微观层面，这旨在打造中央企业高质量发展“第二增长曲线”。当下，增强战略性新兴产业整合能力将为中央企业开辟“第二增长曲线”、破解市值管理瓶颈提供历史机遇。通过快速并购切入人工智能、新能源、高端装备等高附加值赛道，中央企业控股上市公司进一步转向以技术壁垒、品牌优势为核心的“智慧型增长”，向资本市场提供企业可持续价值增值预期，进而从根本上改善估值逻辑。综上，国资央企向“新”并购，是宏观国有资产保值增值、中观产业生态构建、微观企业动能激活的同频共振，三重逻辑层层递进、相互支撑。（参考：证券日报）行业观察重要资讯 6．中核集团：《核技术应用产业链强链行动计划》发布近日，我国首个《核技术应用产业链强链行动计划》以及《核技术应用产业年鉴2025年卷》、2025核技术应用产业链供需清单等成果，标志着我国核技术应用产业进入以系统性强链行动推动高质量跃升的新阶段。核技术又称同位素与辐射技术，通常指非动力民用核技术，是现代科技的重要组成部分，其相关产业具有高科技、高效能、高质量的特征。（来源：能源新闻） 7．北京：加速布局太空数据中心近日，“智绘星空胜算在天——太空数据中心建设工作推进会”在北京举行，北京拟在700-800公里晨昏轨道建设运营超过千兆瓦（GW）功率的集中式大型数据中心系统，以实现将大规模AI算力搬上太空。数据中心建设分为三个阶段：2025年至2027年，突破能源与散热等关键技术，迭代研制试验星，建设一期算力星座；2028年至2030年，突破在轨组装建造等关键技术，降低建设与运营成本，建设二期算力星座；2031年至2035年，卫星大规模批量生产并组网发射，在轨对接建成大规模太空数据中心。根据建设规划，3年内星座太空算力将达1,000P（每秒千万亿次浮点运算），2030年提升至40万P，相当于中国所有地面数据中心算力总和，将在6G、自动驾驶和气象预报等领域发挥关键作用。（来源：腾讯网） 8．美国：第二轮医保谈判结果公布近日，美国第二轮医保谈判结果正式公布。第二轮谈判的影响比去年更大，涵盖15种药物，多于去年的10种。最高降幅达到85%，也高于去年的79%。据联邦医疗保险和医疗补助服务中心（CMS）估计，在2024年全年，约有530万联邦医疗保险（Medicare） D部分覆盖者使用上述15种药物进行治疗，处方药总成本约425亿美元，占Medicare D部分总成本的大约15%。当谈判定价在2027年生效时，与2024年Medicare在这些产品上的净支出相比，谈判后将净节省44%的开支，约120亿美元，这也高于第一轮医保谈判预计将节省的60亿美元。（来源：医药魔方）院研观点 9．国际能源署：电气化进程重塑世界能源版图国际能源署最新指出，未来十年电力将成为全球能源体系变化的核心力量，电气化将比任何单一技术路径更快、更深地重塑世界经济结构。这不仅是技术扩散的结果，更是能源安全逻辑、产业竞争格局和治理方式全面转向的表现。可以说，电气化进程的加速，正在推动电力系统重塑世界能源版图。电气化是一场贯穿供需两端的结构重塑，既是对传统能源体系的主动退潮，也是对数字化、智能化社会形态的系统催化。围绕电力的竞争、协同与治理，将在未来十年愈发成为全球经济竞争的关键维度。当电动汽车、热泵、电炉、电动工业装备等终端技术在各区域快速扩散，能源系统的重心随之从油气链条转向电力系统。国际能源署预计，到2030年，全球新增电力需求有超过六成来自电气化带动的终端替代。这意味着电力正在取代石油，成为世界经济运行的主要能源输入；电力成本、电力可靠性、电网承载力，正在决定产业布局、供应链稳定程度以及一个经济体的未来竞争力。电力越清洁、越可靠、越便宜，产业发展空间就越大。电气化带来增长的同时，也带来前所未有的压力。可再生能源在新增装机中占据主导，使得电力系统复杂度急剧上升。风光的大规模接入意味着电力系统必须依靠调节能力撑，即来自储能、智能电网、灵活负荷等跨端联动。根据国际能源署判断，到2030年前后，全球电力系统将全面进入高增长、高压力的结构性调整期，若投资不足或治理滞后，电气化红利很可能在局部地区转化为供需紧张、成本上升甚至系统不稳的风险。总体而言，电气化是一场深刻的系统性变革，正成为全球能源格局重构的底层力量。它决定能源结构的走向，也决定产业结构的形态；改变电力行业的功能，也改变终端用户的角色；提升能源系统的清洁性，同时也提高系统治理的复杂性。（参考：人民网） 10．阿尔茨海默病：疾病修饰疗法破局，开启早筛市场新纪元阿尔茨海默病（Alzheimer’s Disease，AD）作为一种神经退行性疾病，已成为全球公共卫生的重要挑战。临床表现为记忆减退、认知功能障碍及生活能力下降，其诊断主要依赖神经心理学测验、影像学检查（如MRI和PET）以及近年来快速发展的生物标志物检测（如脑脊液检测和血浆检测等）。疾病进展通常经历临床前阶段、轻度认知障碍期（MCI）直至痴呆期。中泰证券预计2025年全球AD诊疗市场规模将达124亿美元，并以9%的年复合增长率（CAGR）增长，到2035年达到294亿美元。其中，中国市场规模预计2025年约为260亿元人民币。这一增长背后，是全球超过5500万痴呆患者（其中AD占比60-70%）带来的巨大医疗需求。阿尔茨海默病的病理机制主要与β淀粉样蛋白沉积形成的老年斑和tau蛋白过度磷酸化导致的神经纤维缠结密切相关。长期以来，临床治疗仅限于多奈哌齐、美金刚等“对症治疗”药物，仅能暂时缓解症状而无法延缓疾病进展。这一困境在2023年被彻底打破——美国FDA连续批准了仑卡奈单抗和多奈单抗两款疾病修饰药物。仑卡奈单抗作为近20年来首款获批的AD疾病修饰疗法，可通过清除大脑中的Aβ斑块显著延缓早期患者认知功能下降达27%；紧随其后的多奈单抗则展现了更为便捷的每月一次给药方案，在临床试验中显示可减缓临床进展达35%。这两款单抗药物的问世，不仅验证了“Aβ假说”的治疗价值，更重要的是标志着AD治疗正式迈入“对因治疗”新时代。随着疾病修饰药物的问世，早期筛查市场开启了新的纪元。有效的早期干预必须在明显认知障碍出现前识别患者，这使得便捷、精准的早筛技术成为刚需。目前，早筛方法主要包括三大方向：血液生物标志物检测（如Quanterix的p-tau217血液检测）、数字认知评估工具（如Linus Health的数字化认知测试平台）以及基因风险筛查（如APOE ε4基因分型），其中血液生物标志物检测可细分为单分子免疫检测、质谱检测、外泌体检测、microRNA检测等。这一领域已涌现出众多创新企业，其中C2N Diagnostics凭借其Aβ42/40血液检测试剂盒获得突破性设备认定；日本的Sysmex公司与卫材制药合作开发的HS Aβ血液检测系统已进入实用阶段；而国内企业也不甘落后，先声诊断的Aβ血液检测产品已启动大规模临床验证，华大基因则通过基因组学技术布局AD早期风险预测。据动脉智库报告，中国AD早筛市场将进入高质量发展阶段，预计到2025年市场规模突破50亿元，血液检测占比超过60%，惠及数千万高危人群，成为精准医疗领域新的增长极。阿尔茨海默病诊疗领域正经历从“无药可治”到“有效干预”的历史性转变。疾病修饰药物的突破性进展不仅为患者带来了希望，更催生了早期筛查百亿级市场。尽管这一新兴市场还面临诊断能力不均衡、检测标准化待完善等挑战，随着血液检测等便捷筛查技术的优化普及、行业标准的统一完善、医疗支付体系的逐步健全，早筛市场有望成为增长最快、潜力最大的环节，为全球生物医药产业带来新一轮发展机遇。（来源：网络资源）企业动态重要资讯 11．万有引力：推出中国首颗5nm MR芯片近日，宁波空间计算新锐企业万有引力（GravityXR）公司推出中国首颗全功能空间计算MR（混合现实）专用芯片“极智G-X100”等三款产品，以及面向生态伙伴的空间计算全栈解决方案。极智G-X100采用5nm制程工艺，是首颗Chiplet架构的异构封装空间计算芯片。该芯片支持8K/120Hz超高清混合现实（MR）显示输出，等效空间计算200TOPS算力，支持合理的分体式计算，覆盖空间定位、眼动追踪、手势识别等全功能。针对当下MR设备算力和重量的冲突痛点设计，极智G-X100在关键指标上刷新多项世界纪录，包括：其P2P（光子到光子）延迟低于10ms，可助MR整机重量优化至100g以内，支持轻量级全功能MR设备功耗低至3W左右。（来源：芯东西） 12．福莱新材：发布芯感一体第三代电子皮肤产品近日，福莱新材召开新品发布会，正式推出集“柔性材料+芯片+算法+大模型”于一体的第三代电子皮肤柔性传感器。第三代电子皮肤拥有三大核心突破：“芯感一体”，柔性传感器内部植入芯片，可在指尖完成边缘计算，实现传感与处理深度融合；智能算法，将原始电压信号转化为机器人可理解的高维物理属性，使机器人对物体拥有深度感知能力；全域触觉感知，增大有效感知面积，让机器人能够获得更丰富、更立体的触觉信息。（来源：证券时报网） 13．阿科玛：与惠普推出新一代3D打印材料HR PA11 Gen2 近日，阿科玛与惠普增材制造解决方案(HP Additive Manufacturing Solutions)宣布推出新一代HP 3D打印高重复使用率材料HR PA11 Gen2。该新一代聚酰胺11材料用于工业领域3D打印，100%生物基，增强机械性能，提高成本效率并显著降低碳足迹。与上一代3D打印PA11规格相比，新一代的PA11使最终3D打印件减少20%~30%的碳足迹，助力制造商实现其可持续发展目标。HP 3D HR PA11使3D打印在汽车、医疗和消费品等领域具有更广泛的应用潜力。（来源：中国化工信息周刊） 14．Tachyum：发布开源TDIMM内存标准近日，Tachyum公司宣布推出全新开源内存标准TDIMM（Tachyum DIMM），为人工智能与高性能计算领域带来技术突破。该标准是继2nm Prodigy系列处理器后，公司的又一重磅成果。TDIMM带宽较DDR5 RDIMM提升5.5倍，达281GB/s，容量覆盖256GB至1TB，通过TSV技术可扩展至单节点3PB。该技术可大幅降低AI数据中心成本与功耗，预计将OpenAI数据中心成本从3万亿美元降至270亿美元。Tachyum将其开源并免费授权，计划2028年实现27TB/s带宽升级，开启人工智能低成本应用新时代。（来源：半导体行业观察） 15．IgA肾病：全球首个靶向APRIL单抗疗法获批上市近日，大冢制药宣布美国FDA加速批准了其单抗药物Voyxact（sibeprenlimab）上市，用于降低存在疾病进展风险的成人原发性免疫球蛋白A肾病（IgAN）患者的蛋白尿水平。据悉Voyxact是首个细胞因子A增殖诱导配体（APRIL）靶向疗法。III期临床试验结果显示，治疗9个月时Voyxact组蛋白尿水平下降50%（安慰剂组上升2%，P<0.0001）；次要终点数据eGFR年化变化率预计将在2026年公布。不良反应发生率略高于安慰剂组，大多数为轻至中度，且无需中断或停止治疗即可自行缓解。（来源：药明康德）关注我们砥砺前行共创未来

2025-11-24

·Business Wire

C2N Diagnostics Awarded Rigorous New York State Department of Health Permit, Expanding Ability to Provide Its Blood Tests to Help Diagnose Alzheimer’s Disease

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”) announces it has received its laboratory permit from the highly respected New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP). This accomplishment allows C2N to offer its PrecivityAD2™ and PrecivityAD® blood tests to help diagnose Alzheimer’s disease in New York State. C2N CEO and President Dr. Joel Braunstein says, “We’re very proud to have met the quality standards established by New York State’s CLEP, which are widely regarded as a national benchmark for clinical laboratory performance." The Empire State joins 49 other states, Washington, D.C., Puerto Rico and select countries across Asia, Latin America, Europe and the Middle East in allowing the Precivity blood tests. The tests aid health care professionals in detecting amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and support informed medical management and treatment decisions. C2N CEO and President Dr. Joel Braunstein says, “We’re very proud to have met the quality standards established by New York State’s CLEP, which are widely regarded as a national benchmark for clinical laboratory performance. Achieving this certification reflects rigorous scientific work by our team and a company-wide commitment to ensuring that every test we deliver meets the highest levels of accuracy and reliability. As a result, we’re now able to help support New York State’s rapidly growing older population.” The New York Alzheimer’s medical community is excited about the news, as it means it has a convenient and affordable way to evaluate patients, a necessary step before new disease-modifying treatments for Alzheimer’s can be prescribed. With two disease-modifying therapies available for the earliest stages of AD, patients and their families understand the benefits of an early and accurate diagnosis. There are many benefits to an Alzheimer’s disease early diagnosis, including: Get appropriate medical attention (including possible access to disease-modifying therapies) Start lifestyle adjustments Become eligible for clinical research Lower risks and plan better Enable earlier access to support Actively plan for your future Dana, a patient, says, “When I heard about the blood test, I was encouraged to come in and have that done, to find out if I was in the category of early Alzheimer’s.” The Precivity tests are only available through health care professionals. The PrecivityAD2™ blood test is intended for use in patients aged 50 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia. Further information is available at www.PrecivityAD.com and 1-877-C2N-DIAG (1.877.226.3424). New York Clearance Builds on Other Milestones The New York State news follows on the heels of other C2N accomplishments. In October, it submitted the first multi-analyte algorithmic blood test using high-resolution mass spectrometry (HRMS) for Food & Drug Administration (FDA) review via the 510k pathway. The Journal of the American Medical Association last year published a landmark clinical study examining the ability of the PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found similar robustness for the PrecivityAD2 test result in patients who saw memory care specialists. The PrecivityAD2 test algorithm delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis. In October, 2020, the company was the first to offer a widely accessible Alzheimer’s disease blood test, the PrecivityAD® test, to aid in the evaluation process. C2N performs the tests in its CAP accredited, CLIA and ISO 13485:2016 certified facility in St. Louis, MO. About C2N Diagnostics, LLC C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, and Mayo Clinic Laboratories Over 50,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, Alzheimer’s Association and The Michael J. Fox Foundation. For more information visit www.c2n.com.

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