The DEPICT Prospective Study: Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury as Assessed by Donor Derived Cell Free DNA Post Transplantation

The goal of this research study is to understand if a blood test in people who have had heart transplants can detect and predict the following:
* Blockages in the small blood vessels of the heart.
* Whether small blockages can turn into more severe blockages in the future.
Participants will undergo blood draws once every 3 months in the first year of the study (4 blood draws total, taking 15 minutes each) and their medical records will be reviewed for 3 years after the date they are enrolled in the study.

开始日期2025-12-01

申办/合作机构

Yale University

[+1]

NCT05733689

/ Not yet recruiting临床1期IIT

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial

This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a ctDNA assay (test) result to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).

开始日期2025-06-01

申办/合作机构

University of California, Irvine

[+1]

NCT06529822

/ Recruiting临床1期IIT

Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.

开始日期2025-03-20

申办/合作机构

Washington University School of Medicine

[+1]

100 项与 Natera, Inc. 相关的临床结果

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0 项与 Natera, Inc. 相关的专利（医药）

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177

项与 Natera, Inc. 相关的文献（医药）

2025-09-01·TRANSPLANT IMMUNOLOGY

Early post-lung transplant cell-free DNA levels are associated with baseline lung allograft dysfunction

Article

作者: Havlin, Jan ; Lischke, Robert ; Vanaudenaerde, Bart ; Zajacova, Andrea ; Dvorackova, Eliska ; Fila, Libor ; Guney, Miray ; Alkhouri, Majd ; Kotowski, Tereza ; Rezac, David ; Ross, David J ; Ferrao, Goncalo ; Dutkova, Alzbeta ; Vyskocilova, Kristyna

BACKGROUND:

Baseline lung allograft dysfunction (BLAD) is defined as the failure to achieve normal pulmonary function-specifically, forced expiratory volume in 1 s (FEV₁) and forced vital capacity (FVC) values of ≥80 %-within the first year after lung transplantation. It is hypothesised that early subclinical injury, reflected by elevated donor-derived cell-free DNA (dd-cfDNA), both in absolute concentration and percentage (dd-cfDNA%), as well as total cell-free DNA (cfDNA), may be predictive of subsequent BLAD development.

METHODS:

We included patients who underwent bilateral lung transplantation between May 2021 and September 2023. Blood samples collected between 3 and 9 months post-transplantation were analysed for dd-cfDNA%, dd-cfDNA concentration (copies/mL), and estimated total cfDNA (copies/mL). BLAD was defined by failure to achieve both FEV₁ and FVC ≥80 % of predicted values within the first year.

RESULTS:

A total of 158 samples from 37 patients were analysed. Ten patients (27 %) met the BLAD criteria. Those with BLAD had significantly higher dd-cfDNA levels (median: 39 cp/mL) compared to non-BLAD patients (26 cp/mL; p = 0.01). Similarly, total cfDNA levels were significantly elevated in the BLAD group (22,809 cp/mL vs. 13,840 cp/mL; p = 0.002). However, dd-cfDNA% did not differ significantly (0.23 % vs. 0.15 %; p = 0.2).

CONCLUSION:

Elevated absolute dd-cfDNA and total cfDNA levels in the early post-transplant period were associated with BLAD, suggesting that cfDNA may serve as a potential predictive biomarker. These findings support the potential of cfDNA-based biomarkers to enhance early detection of graft dysfunction, warranting validation in larger cohorts.

2025-06-01·TRANSPLANTATION PROCEEDINGS

A Novel Method to Estimate Donor-Derived Cell-Free DNA in Pregnant Kidney Transplant Recipients: A Proof-of-Concept Study

Article

作者: Al Haj Baddar, Nour ; Zimmermann, Bernhard ; Charland, Nicole ; Jang, Christine ; Tabriziani, Hossein ; Van Hummelen, Paul ; Afshar, Yalda ; Woodruff, Kate ; Bunnapradist, Suphamai ; Ahmed, Ebad ; Heilek, Gabrielle ; Tang, Jessica ; Ligumsky, Lior Kashani

BACKGROUND:

Pregnant kidney transplant recipients (KTRs) are a vulnerable, high-risk population, susceptible to obstetrical complications, as well as graft rejection. Current methods used to monitor kidney transplant function lack specificity. Recently, donor derived cell-free DNA (dd-cfDNA) has emerged as a non-invasive biomarker for assessing risk for allograft rejection in KTRs. However, utilizing dd-cfDNA to monitor allograft status in pregnant KTRs requires the ability to distinguish between fetal/placental, donor, and KTR derived cfDNA.

METHODS:

We developed a custom bioinformatics analysis to identify and measure dd-cfDNA in 6 pregnant KTRs by sequencing maternal cfDNA (blood sample) and paternal genomic DNA (buccal swab).

RESULTS:

We demonstrate our ability to successfully measure dd-cfDNA in 4/6 pregnant KTRs.

CONCLUSIONS:

This proof-of-concept study demonstrates that dd-cfDNA can be measured in pregnant KTRs. This study lays the foundation for future research on dd-cfDNA correlations with maternal fetal conditions to help improve allograft care for this specific patient population.

2025-05-01·ESMO Open

Tumor-informed ctDNA assay to predict recurrence in locally advanced squamous-cell carcinoma of the head and neck (SCCHN)

Article

作者: Machiels, J-P H ; Velichko, S ; Liu, M ; Aushev, V ; Dahou, H ; Palsuledesai, C ; Laliotis, G ; van Marcke, C ; Honoré, N ; Galot, R

BACKGROUND:

Despite multimodal treatment, locally advanced (LA) squamous-cell carcinoma of the head and neck (SCCHN) has a recurrence rate of ∼50%. Circulating tumor DNA (ctDNA) has emerged as a potential biomarker for minimal residual disease detection after curative-intent treatment. This strategy could be used to identify the patients at greater risk of recurrence, for whom extended or intensified therapy and/or surveillance imaging may be considered.

MATERIALS AND METHODS:

A personalized, tumor-informed 16-plex multiplex PCR-next-generation sequencing assay was used for the detection of ctDNA in banked plasma samples collected pre-treatment (baseline time point) and within 12 weeks from the end of curative-intent treatment (post-treatment time point). The primary and secondary endpoints were recurrence-free-survival (RFS) and overall survival (OS) of post-treatment ctDNA-positive and -negative patients, respectively.

RESULTS:

Out of a cohort of 50 patients with LA SCCHN, personalized ctDNA assays were successfully designed for 43 patients. Among these 43 patients, ctDNA was detected in 42 of 43 (97.6%) patients at baseline. At the post-treatment time point, ctDNA was detected in 4 of 42 (9.5%) patients, 3 of whom relapsed. Of the 43 patients, 11 (26%) experienced disease recurrence within 2 years of follow-up. Patients with post-treatment ctDNA positivity demonstrated a significantly inferior RFS and OS (P ≤ 0.05), compared with ctDNA-negative patients. The median lead time for ctDNA positivity over clinical recurrence was 7.0 months (range 3.6-7.1 months).

CONCLUSIONS:

The personalized, tumor-informed assay detected pre-treatment ctDNA in the majority of the patients with LA SCCHN. ctDNA positivity within 12 weeks of completing curative-intent treatment was predictive of worse RFS and OS. These results support studies to assess the value of longitudinal testing for surveillance and may open the path to initiating treatment upon molecular recurrence in patients with LA SCCHN.

266

项与 Natera, Inc. 相关的新闻（医药）

2025-05-17

·循因缉药

Personalis 2025Q1：小众NGS诊断公司要逆袭？

球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好！星球首发，加入方法如下。小编在这里！星球在这里！就在我们前两天报道Myriad Genetics的暴跌时，一位老朋友走进了视线。他就是那家Tempus看上的小众NGS诊断公司-Personalis。财报公布后，当日上涨了21%。这...真让Myriad汗颜。是因为财报非常优秀吗？Personalis要逆袭？#01也就一般翻了下公司财报，Personalis 2025Q1营收2060.5万美元，同比增长5.5%，环比增长22.6%。当季亏损1575万美元，同比扩大21.5%，环比做摘4.1%。呃，不能说很优秀吧，只能说非常一般。在看这张图，这2060.5万美元甚至不是最近两年的最高点。你说，他何德何能？难道，是2025年的财务指引逆天了？看了下，根本没有变啊。仍然维持2025全年营收8000万~9000万美元区间，只有毛利率略微提高了1个百分点，净亏损下调了200万美元。#02藏在标题里高端的信息，总是放在最显眼的位置...没想到，竟然是2025Q1完成了2184例临床样本，相较于2024Q4提高了52%。为啥没有2024Q1同期对比的结果呢？当然是因为太过夸张。。。回溯了下，2024Q1的临床样本似乎只有338个...之所以说是似乎，这货表述不是很一样，大家凑合着看吧。总之，这个势头是很猛的。这事为啥重要呢，Personalis之前跟Natera合作“代工”检测。但是2025年初就到期了，于是我们看上图的Enterprise sales出现了暴降69%的“冥场面”。因此，Personalis急需其他产品线进行补位。虽然这个补位，目前看起来情绪价值大于实际价值。不过，人家想象空间充分啊。情绪价值，也是价值...#03稳住，别浪2025年，Personalis的口号依然是“MRD制霸”（“Win-in-MRD”）。预计，本年度还有两个临床要完成。这将能够支持Medicare对MRD的支付覆盖，为公司提供更广的收入来源。不过，很显然，Myriad几年也要“赢在MRD”...所以，Personalis 2025年的挑战还是不小的。需要注意的是，2025Q1的增长主要依赖于药企合作和退伍军人服务部门的订单。临床贡献，微乎其微。而这两项尤其是退伍军人服务部门的订单，具有较大的波动性。2025Q1还是运气好了点，就此上头大可不必。我们还需要再观察下这种趋势是否能够延续，不能过早下结论。在回答投资者提问环节还有个很有意思的事情。有投资人问：在本季度进行的2100次检测中，有多少是由之前使用过该测试的医生进行的？回答：医生的留存率非常高，一旦开始使用Next Personal，他们通常会持续使用。公司目前有数百名医生在下单，其中包括新医生和重复下单的医生。此外，公司还发现，随着时间的推移，医生会为同一患者进行多次检测，这也有助于推动业务增长。要注意，Next Personal是个MRD检测，同一患者本身就要多次监测啊...END小编在这里！星球在这里！各位股东看了么？赞了么？转发了么？别忘了点赞。谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。近期文章：重磅！Illumina因美纳起诉Element BiosciencesQuanterix崩了空间生物学领域迎来史诗级诉讼和解赛默飞也扛不住相关资料：注1：https://investors.personalis.com/news-releases/news-release-details/personalis-reports-first-quarter-2025-financial-results注2：https://investors.personalis.com/static-files/ba741765-7445-42cf-b23b-edf85bae2554注3：https://investors.personalis.com/static-files/3c11319a-f39a-4a31-bcd3-1702b82adf4d

财报信使RNA

2025-05-15

·循因缉药

空间生物学领域迎来史诗级诉讼和解

全球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好！星球首发，加入方法如下。小编在这里！星球在这里！2025年5月14日，10x Genomics宣布与Bruker达成法律诉讼和解协议。这项和解协议涉及双方全球范围内的专利诉讼纠纷，主要是Bruker收购的NanoString与10x Genomics在空间生物学专利的纠纷。据悉，10x Genomics将收到6800万美元的和解金和后续的版税。这部分将以分期付款的方式在2025Q3和2026Q2按照50:50的比例支付。此前，10x Genomics已经与Vizgen达成和解，获得2600万美元和解金首付款。至此，10x Genomics全球范围内的空间生物学专利诉讼基本告一段落。可惜的是，NanoString已经不在了...至于二者能达成和解，我的猜测是：这也可能与10x Genomics目前面临的经营困境有关。在2025Q1财报中，10x Genomics被迫撤回了之前的全年财务指引，并裁掉约100名员工。#01小背景2023年5月19日，我们独家披露了10xGenomics在德国慕尼黑地区法院对NanoString专利侵权案的结果。根据判决同时生效的禁令，NanoString在德国境内不能再销售CosMx SMI设备和对应的RNA检测试剂。2023年6月1日，10xGenomics发布公告，公司对NanoString在欧洲联合专利法院（Unified Patent Court，UPC）提起诉讼，指控NanoString侵犯了其2794928B1（EP928专利）和4108782B1专利（EP782专利）。2023年9月19日，10x Genomics再次发布公告，宣布获得UPC颁布的临时禁令。根据禁令，NanoString在UPC管辖内的17个国家不能再销售CosMx SMI设备和对应的RNA检测试剂，亦不能提供相应的服务。这17个国家分别是Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia 和Sweden.2024年7月18日，Bruker（布鲁克）发布公告，旗下NanoString 空间生物学产品CosMx在德国的销售禁令已经解除。从即日起，CosMx全部产品包括蛋白和RNA检测产品，均可在德国销售。（感兴趣的也可以搜索我们公众号，挺全了）END小编在这里！星球在这里！各位股东看了么？赞了么？转发了么？别忘了点赞。谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。近期文章：赛默飞也扛不住Ginkgo已经“进化”到看不懂了...Guardant Health：关税是啥？预计2025年营收增长20%中美“关税战”降级后的赢家是谁？后槽牙咬碎！Natera的MRD 一季度干了16.1万例10x Genomics CEO 炮轰美国联邦政府相关资料：注1：https://www.prnewswire.com/news-releases/10x-genomics-announces-patent-litigation-settlement-agreement-with-bruker-302455792.html

专利侵权并购财报

2025-05-14

·循因缉药

赛默飞也扛不住

全球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好！星球首发，加入方法如下。小编在这里！星球在这里！上一季度，我们刚夸过赛默飞。没想到强如赛默飞，也扛不住了。#01“无人幸免”2025年4月23日，Thermo Fisher（TMO）公布了2025Q1的财报。财报显示，2025Q1营收达到103.6亿美元，同比增长0.2%，环比下滑9.0%。公司调整后的EPS为5.15美元，同比增长0.8%，环比下滑15.6%。从趋势上来看，似乎Q1都是处于全年的低点。但是，在叠加了下图之后，我们发现2025Q1确实有点难。我们可以发现，2025Q1 TMO所有的业务板块都在环比下滑。这事，在2024Q1上并不是这样的。我们看这张表更清楚。2024Q1的营收只比2023Q4差了5.41亿美元，而2025Q1可是比2024Q4差了10.31亿美元哦。而所有的板块都在环比下滑...无人幸免。#02中美失速从区域上来看，环比均在下降，尤其是亚太区，下滑了14.1%。同比倒还好，基本没太大问题，主要是看2025后面几个季度能不能上来。中美之间的关税战虽然我们现在知道了已经暂停了升级对抗，但是在彼时TMO管理层给出的预估是减少大约4亿美元的收入。在财报会上，公司管理层表示Q1即便没有关税影响中国区的营收也出现了中个位数下滑（也就是5%左右）。在关税不确定性的影响下，估计后面几个季度依然承压。美国区的增长也有点乏力，大家可以看到本季度美国区营收已经是处于最近1年的最低点。财报会上 CEO 提到临床研究业务中有2亿美元的疫苗相关研究被取消或暂停，其中一半由政府通过创新者直接资助。这显然会影响到TMO的业绩。然而，管理层似乎对NIH的改革抱有信心。TMO认为NIH拨款由国会决定，而国会强烈支持NIH。潜台词是，特朗普政府是无法干预NIH的预算的。但是，我并不这么认为。特朗普可以通过HHS和总统办公室行政命令高频次的政策扰动，干预NIH的运作。即便拨款到了，他也有100种办法让这钱没办法花出去。或者，只能拨款给他和他团队认为应该花的领域。#03未来的底气本次，Thermo也对2025年度财务指引做出了调整。营收方面，全年433亿~442亿美元，相较于2024Q4的435亿~440亿美元低端下调2亿美元，高端上调2亿美元。呃，主打一个乐观、悲观预计都考虑到。不过，调整后的EPS比较实诚，从23.1~23.5美元下调到21.76~22.84美元。这也有可能2025年2月份41亿美元收购SOVENTUM造成的。财报会上，管理层表示美国当前政策的变化造成的宏观环境不确定性公司有能力在2025年抵消大部分影响，并且在明年更充分的吸收这部分冲击。你看，这就是大公司的底气。#04最后本季度，TMO又回购了10亿美元股票。要知道，2024Q4的时候已经回购10美元了...作为股东，你不爱这样的公司么？要拒绝这样的诱惑还是很难的...仅计算现金、现金等价物和短期投资，Thermo账上就有近60亿美元...嘴角流下羡慕的泪水..。END小编在这里！星球在这里！各位股东看了么？赞了么？转发了么？别忘了点赞。谢谢！所有内容均不作为投资建议，信息均来自公开资料，星球更新更快。近期文章：Guardant Health：关税是啥？预计2025年营收增长20%中美“关税战”降级后的赢家是谁？后槽牙咬碎！Natera的MRD 一季度干了16.1万例10x Genomics 决定裁员并撤回财务指引中国限制、科研缩减、关税挑战：Illumina三座大山压顶相关资料：注1：https://s27.q4cdn.com/797047529/files/doc_financials/2025/q1/Q1-25-10Q.pdf注2：https://ir.thermofisher.com/investors/news-events/news/news-details/2025/Thermo-Fisher-Scientific-Reports-First-Quarter-2025-Results/注3：财报电话会纪要

财报疫苗信使RNA

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100 项与 Natera, Inc. 相关的转化医学

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