The main objective of this project is to analyze the effect of a tailor-made, one-to-one, exercise program (aiming to treat and handle obesity-related comorbidities in adolescents with severe obesity at high risk of cardiovascular disease development) on BMI z-score, specific comorbidities, and other health-related indicators.
This project will further allow to analyze the long-term impact of the exercise program not only on clinical parameters, but also on the interaction with drug-treatment, health-related behaviors, and quality of life, further contributing to the understanding of the individual characteristics associated with a positive exercise response and frequency.
The secondary objective of the THOR-X project is to build an educational toolkit, based on project results and relevant literature, addressed to health and exercise professionals, in order to improve management of adolescents with obesity, in particular those with severe obesity.

开始日期2025-01-01

申办/合作机构

University of Lisbon

NCT06472414 / RecruitingN/AIIT

Effects of a Women-Focused Maintenance Cardiovascular Rehabilitation Program on Adherence, Health Related Physical Fitness, and Quality of Life: a Randomized Controlled Trial

Cardiovascular disease (CVD) remains leader of global causes of death worldwide and recent documented trends show a rise in acute myocardial infarction in younger women. Compared to men, women have a higher cardiovascular risk due to hypertension, dyslipidaemia, diabetes mellitus, obesity, physical inactivity, and a sedentary lifestyle. Plus, they have additional sex-specific cardiovascular risk factors such as gestational hypertension/diabetes, preterm delivery, premature menopause, and polycystic ovary syndrome.
Cardiovascular rehabilitation (CR) is a Class I, level A, clinical practice guideline recommendation, multidisciplinary secondary prevention program that has been shown to reduce cardiovascular mortality, rehospitalization, and improve quality of life. Despite all established benefits, CR continues to be under referred to women compared to men, with lower enrolment rates and lower adherence to exercise sessions. The reasons for the underuse of CR by women and the main barriers have been widely studied. Thus, sex-specific implementation strategies have been developed to improve adherence, however, the efficacy claims of these interventions are equivocal, as some studies revealed no significative difference regarding adherence between different exercise delivery modes and mixed-sex programs, whereas others revealed greater preference towards women-only programs.
Few randomized controlled trials (RCT) examined the efficacy of CR programs tailored to women in adherence, enrolment, functional capacity, physical activity, body composition, and quality of life. Importantly, to the investigators knowledge, no RCTs used counselling sessions, women-focused educational sessions, personalized follow-ups and supervised exercise sessions as adherence strategies in maintenance CR community programs.
The goal of this RCT is to test whether a women-focused maintenance CR community program increases adherence compared to a standard care. Thus, the investigators hypothesized that:
• The women-focused group will have greater adherence to the CR community program (main outcome)
Participants will:
* Be assessed at baseline, at 3-months and at 6-months
* Enrol in a supervised community-based maintenance CR program
* Receive individually prescribed exercise sessions (both groups), a tailored package consisting of individual counselling sessions and educational sessions (women-focused group)

开始日期2024-10-08

申办/合作机构

University of Lisbon

NCT06483438 / CompletedN/AIIT

Handwriting as an Objective Tool to Support the Identification of People With Alzheimer's Disease: Suitability of an Assessment Protocol

Alzheimer's disease (AD) is the most common of dementia, and has associated cognitive and motor disorders, with consequences on daily activities, including handwriting.
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations. Changes in this skill are present at different stages of the clinical course of Alzheimer's Disease. The sensorimotor deterioration is observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles) and brain activity rhythms.
Handwriting has been used to study fine motor control or executive functioning in healthy and unhealthy populations, and changes in this skill are present at different stages of the clinical course of dementia. From a theoretical perspective, because sensorimotor deterioration observed in handwriting tasks (motion kinematics, such as movement time, speed, and profiles).
Due to the large number of brain areas related to handwriting performance, brain electrical activity analysis can be an early indicator of brain dysfunction. Although there is a lack of validation across healthy and non-healthy populations Electroencephalogram (EEG) measures have the potential for evaluating cognitive performance.
This research aims to analyze the suitability of the handwriting assessment protocol, which can contribute to a more in-depth knowledge of this subject and potentially support early identification and treatment.

开始日期2023-12-02

申办/合作机构

Nova Medical Services

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项与 University of Lisbon 相关的文献（医药）

2025-02-01·BIOELECTROCHEMISTRY

Polynorepinephrine and polydopamine-bacterial laccase coatings for phenolic amperometric biosensors

Article

作者: Zeferino, Jorge F. ; Zeferino, Jorge F ; Almeida, Luís C ; Morana, Alessandra ; Ihalainen, Petri ; Sobhana, Liji ; Viana, Ana S ; Squillaci, Guiseppe ; Branco, Clara ; Santos, Romana ; Correia, Jorge P. ; Viana, Ana S. ; Correia, Jorge P ; Almeida, Luís C.

The successful fabrication of biosensors is greatly limited by the immobilization of their bioreceptor, thus we propose a facile and reproducible two-step method to modify graphite electrodes with a bacterial laccase, relying on a fast and controllable potentiostatic process to coat graphite surfaces with biomolecule-compatible thin films of polynorepinephrine (ePNE) and polydopamine (ePDA). Both polymers, synthesized with a similar thickness, were functionalized with bacterial laccase, displaying distinct electrochemical transducing behaviours at pH 5.0 and 7.0. ePNE layer enables adequate electron transfer of anionic and cationic species in acidic and neutral media, whereas transduction across ePDA strongly depends on pH and redox probe charge. ePNE stands out by improving the amperometric responses of the biosensing interface towards a phenolic acid (gallic acid) and a flavonoid (catechin), in respect to ePDA. The optimal graphite/ePNE/laccase interface outperforms biosensing interfaces based on fungal laccases at neutral pH, displaying detection sensitivities of 104 and 14.4 µA cm^-2 mM^-1for gallic acid and catechin, respectively. The fine synthetic control of the ePNE bio-inspired transduction layer and the use of an alkaliphilic bacterial laccase enabled the construction of an amperometric biosensing interface with extended pH range of polyphenols detection present in food products and agro-industrial waste.

2025-01-01·JOURNAL OF AFFECTIVE DISORDERS

Exploring the impact of depression, anxiety, stress, academic engagement, and dropout intention on medical students' academic performance: A prospective study

Review

作者: Oliveira, Pedro ; Sinval, Jorge ; Almeida, Carla Maria ; Novais, Filipa ; Telles-Correia, Diogo

BACKGROUND:

Depression, anxiety, and stress (DAS) have been linked to poor academic outcomes. This study explores the relationships among DAS, academic engagement, dropout intentions, and academic performance - measured by Grade Point Average (GPA) - in medical students. It aims to understand how these factors relate to each other and predict academic performance.

METHODS:

Data were collected from 351 medical students (74.9 % female) through an online survey. The average age was 20.2 years. Psychometric instruments measured DAS, academic engagement, and dropout intentions. Structural equation modeling was used to test the relationships between these variables and their prediction of GPA.

RESULTS:

DAS was negatively associated with academic engagement β̂=-0.501p<0.001 and positively associated with dropout intentions β̂=0.340p<0.001. Academic engagement positively predicted GPA β̂=0.298p<0.001 and negatively associated with dropout intentions β̂=-0.367p<0.001. DAS had a nonsignificant direct effect on GPA β̂=-0.008p=0.912. However, the indirect effect of DAS - via academic engagement - on GPA and dropout intention was statistically significant.

LIMITATIONS:

The study's limitations include the use of a convenience sample and the collection of all variables, except GPA, at the same time point, which may affect the generalizability of the results.

CONCLUSIONS:

The study supports the important role of DAS in its association with academic engagement and dropout intentions, which can predict GPA. Addressing DAS could enhance academic engagement and reduce dropout rates, leading to better academic performance.

2024-12-31·Gut Microbes

Gene content, phage cycle regulation model and prophage inactivation disclosed by prophage genomics in the Helicobacter pylori Genome Project

Article

作者: Camargo, M. Constanza ; Roberts, Richard J. ; Vale, Filipa F. ; Rabkin, Charles S. ; Kobayashi, Ichizo

Prophages can have major clinical implications through their ability to change pathogenic bacterial traits. There is limited understanding of the prophage role in ecological, evolutionary, adaptive processes and pathogenicity of Helicobacter pylori, a widespread bacterium causally associated with gastric cancer. Inferring the exact prophage genomic location and completeness requires complete genomes. The international Helicobacter pylori Genome Project (HpGP) dataset comprises 1011 H. pylori complete clinical genomes enriched with epigenetic data. We thoroughly evaluated the H. pylori prophage genomic content in the HpGP dataset. We investigated population evolutionary dynamics through phylogenetic and pangenome analyses. Additionally, we identified genome rearrangements and assessed the impact of prophage presence on bacterial gene disruption and methylome. We found that 29.5% (298) of the HpGP genomes contain prophages, of which only 32.2% (96) were complete, minimizing the burden of prophage carriage. The prevalence of H. pylori prophage sequences was variable by geography and ancestry, but not by disease status of the human host. Prophage insertion occasionally results in gene disruption that can change the global bacterial epigenome. Gene function prediction allowed the development of the first model for lysogenic-lytic cycle regulation in H. pylori. We have disclosed new prophage inactivation mechanisms that appear to occur by genome rearrangement, merger with other mobile elements, and pseudogene accumulation. Our analysis provides a comprehensive framework for H. pylori prophage biological and genomics, offering insights into lysogeny regulation and bacterial adaptation to prophages.

项与 University of Lisbon 相关的新闻（医药）

2024-10-16

·生物谷

有“朋友圈”的细菌更厉害？Cell：新研究发现肠道微生物群居时更能抵抗药物！

在一项新的开创性研究中，来自欧洲分子生物学实验室、图宾根大学、剑桥大学、于默奥大学和里斯本大学的研究人员比较了大量孤立生长的细菌与复杂微生物群落中的细菌之间药物与微生物群落的相互作用。他们发现，当这些孤立生长的细菌形成微生物群落时，人类药物对它们的影响会减弱。相关研究结果于2024年9月24日在线发表在Cell期刊上，论文标题为“Emergence of community behaviors in the gut microbiota upon drug treatment”。在这项研究中，研究人员探究了30种不同的药物（包括针对传染性和非传染性疾病的药物）如何影响32种不同的细菌。根据五大洲的数据，这32种细菌被选为人类肠道微生物组的代表。他们发现，当某些耐药细菌聚集在一起时，会表现出保护其他对药物敏感的细菌的群体行为。这种“交叉保护（cross-protection）”行为使这些敏感细菌在群落中正常生长，而如果它们孤立生长，它们就会被药物杀死。论文共同第一作者Sarela Garcia-Santamarina说，“我们没有预料到这么大的恢复力。令人非常惊讶的是，在多达一半的情况下，细菌物种在单独生长时会受到药物的影响，但在群落中却不受影响。”这就像一群朋友互相支持，即使面对强大的敌人也不轻易倒下。研究团队随后深入研究了这种交叉保护的分子机制。论文共同第一作者Michael Kuhn解释说，“这些细菌通过摄取或分解药物来互相帮助。这些策略分别被称为生物累积（bioaccumulation）和生物转化（biotransformation）。”这就好比一些细菌朋友承担了“解毒”的任务，保护其他朋友免受药物的伤害。图片来自Cell, 2024, doi:10.1016/j.cell.2024.08.037 论文共同通讯作者Michael Zimmermann说，“这些发现表明，肠道细菌转化和积累药物的潜力比以前想象的要大。”这不仅改变了我们对肠道微生物的理解，也为开发新的治疗方法提供了新的思路。不过，这种群落的力量也是有限度的。研究团队发现，高浓度药物会导致肠道微生物组中的微生物群落崩溃，这些交叉保护策略会被“交叉致敏（cross-sensitization）”所取代。在交叉致敏过程中，通常对某些药物具有抗药性的细菌在群落中会变得对这些药物敏感——这与作者在药物浓度较低时看到的情况恰恰相反。这就像在一个高剂量的药物攻击下，原本坚强的朋友圈也会瓦解，甚至变得更加脆弱。就像他们研究的细菌一样，研究团队在这项研究中也采取了群体策略，将他们的科学优势结合起来。作为一项具有前瞻性的实验，他们还利用交叉保护相互作用的新知识组装了合成群落，这些群落在药物处理后仍能保持其成分不变。论文共同通讯作者Peer Bork说，“这项研究为我们了解药物如何影响肠道微生物组奠定了基础。在未来，我们或许可以利用这些知识来定制处方，以减少药物副作用。”论文共同通讯作者Kiran R. Patil补充说，“为了实现这一目标，我们还在研究营养物质如何影响物种间的相互作用，这样我们就能建立更好的模型，了解细菌、药物和人类宿主之间的相互作用。” 参考资料： Sarela Garcia-Santamarina et al. Emergence of community behaviors in the gut microbiota upon drug treatment. Cell, 2024, doi:10.1016/j.cell.2024.08.037. 本文仅用于学术分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！点击下方「阅读原文」，前往生物谷官网查询更多生物相关资讯~

微生物疗法临床研究

2024-07-03

·动脉网

又一植入式脑机接口企业获批人体试验，面向千万中风幸存者

在Neuralink公布其首位植入设备的志愿者遭遇脑内微细线头轻微移位的消息后不久，2024年5月，FDA再次为Neuralink的第二例人体临床研究亮起了“绿灯”。自Neuralink诞生之初，埃隆·马斯克便雄心勃勃地预言，公司将在2020年末开启人类脑机接口植入的临床研究。三年后，这场备受瞩目的马斯克与美国FDA间的漫长博弈，随着植入设备临床研究的稳步推进而逐渐降温。在Neuralink“一枝独秀”的聚光灯背后，有一家来自德国的植入式脑机接口企业CorTec同样于2024年5月获得美国FDA的研究性设备豁免（IDE）申请许可，并将于2024年Q3开展第一例人体植入手术。相较于Neuralink让人类“只需通过意念”就能控制手机或电脑，CorTec的临床研究则是关注于“疾病治疗”，研究神经疾病的创新疗法。这项人体研究由华盛顿大学医学院（UWSOM）神经外科Jeffrey G. Ojemann教授团队与加州大学洛杉矶分校（UCLA）脑卒中神经病学家Steven C. Cramer教授团队领衔。该研究由美国国立卫生研究院（NIH）资助。开发四种共计十余款植入电极，拥有定制化服务能力马斯克曾多次公开表示，Neuralink的目标是“让盲人复明、让瘫痪者行走”，但从目前的进度看，虽然公司技术已跨越了人体植入的里程碑，但无论是通道数量、技术成熟度还是安全性，都距离治病救人相距甚远。对比之下，CorTec研发的这款名为Brain Interchange System（BIS）的植入式脑机接口系统为中风康复治疗提供了一种创新解决方案，即使用皮质刺激来增强大脑可塑性。从解决方案的构成上来看，BIS由植入电极AirRay、外部无线通信设备以及带软件接口的外部计算机组成。 Brain Interchange System 图源：cortec-neuro.com 采集大脑电信号并提供刺激的植入式微电极是脑机交互的关键基础，电极的设计、材料选择，以及它们与大脑组织的相互作用都对脑机接口的性能有着显著影响。虽然CorTec研发的植入电极AirRay在尺寸和通量等参数上与Neuralink的柔性微电极存在一定差距，但公司依然以其独特的优势赢得了美国FDA的IDE许可。这些优势可以概括为以下三点： ● 超精密激光加工技术，可生产小至25µm的电极丝 CorTec采用自研的超短脉冲激光微加工技术，可确保电极制造精度以及生产的可重复性，最小能够制作出25µm的电极丝，约为发丝截面尺寸的二分之一。一方面，单个电极丝尺寸越小，对周围神经组织的机械损伤就越小，可降低长期免疫反应和瘢痕组织形成；另一方面这也意味着可以在有限的面积内更密集地部署电极，从而提高对神经元活动的记录精度和通量。 Neuralink对外公布的电极丝外径约为4～6µm，虽然二者在尺寸上仍存在差距，但尺寸最终是为具体的应用目标服务的，例如太小的电极可能无法满足特定刺激需求。并且，从商业化的加工精度和成本效益比来看，电极丝的尺寸同样不是越小越好。 ● 形状与功能均可定制化设计，满足更多临床场景需求 CorTec通过改变AirRay的硅胶、派瑞林涂层（Parylene-C）或金属层厚度，可生产出更柔软或更坚硬的电极；此外，AirRay的标准电极材料采用铂铱合金和MP35N（镍钴铬钼合金），同时公司也可根据特殊需求提供其他材料。基于以上性能和材料的灵活性，CorTec可以根据下游的要求，定制化设计并生产任何形状的植入电极，满足受技术产品制约发展的脑科学下游需求。例如为周围神经系统设计的神经袖带电极（Cuff Electrode）；为中枢神经系统设计的组合栅极和条形电极（Grid and Strip Electrodes）；用于皮下、脊髓内或深脑等位置的经皮电极（Percutaneous Electrodes）；为中枢神经系统设计的叶片电极（Paddle Electrodes）。 AirRay Grid and Strip Electrodes 图源：cortec-neuro.com ● 机械锁定设计，提高植入电极的安全性和手术可操作性据Neuralink公布的首位人体试验的阶段性结果，N1的大部分接收信号的电极丝中85%都出现了移位脱落，只有约15%的电极丝在正常工作。这意味着N1能收集到的大脑信息在减少，控制也不如刚植入时那么灵敏。虽然Neuralink最后通过修改解码神经元信号的算法，改进每秒位数（BPS）速率，使N1再回之前的状态，但如何避免再出现类似的问题同样至关重要。为了保障患者安全以及植入物的长期效果，CorTec采用机械锁定设计，防止电极移位，确保与神经组织的稳定接触。此外，AirRay还具有良好的机械适应性，能够根据不同植入条件，调整自身的机械性能。这不仅简化了手术操作流程，而且确保电极即使在重复使用条件下，也能保持功能的完整性。为疾病治疗提供闭环解决方案，“比Neuralink更进一步” 在过去30年间全球脑卒中患者人数、死亡或残疾人数几乎翻了一番。《柳叶刀-神经病学》联合世界卒中组织发布“减少全球脑卒中负担的实用性解决方案”指出，如果不采取紧急措施，到2050年，全球死于脑卒中的人数预计将增加50%，达到每年970万人。所有的脑卒中患者，在经过急性期的治疗后或多或少会遗留一些功能残疾，即脑卒中后遗症。在目前医疗技术尚不能有效治愈的情况下，康复治疗尤为重要。更重要的是，30年前卒中患者主要期望能“活下来”。而现在，患者期望的不仅是“活下来”，还要活得有质量、有尊严。但不幸的是，在接受标准护理和康复治疗后，约50%的患者仍会遭受严重影响生活质量的后遗症。面对患病人群数量大、增速快，但目前尚未有好的治疗手段的卒中康复需求，基于大脑可塑性的脑机接口恰好有希望完成补位，提高康复治疗的效果。在两位教授的先前研究中，已证实虽然脑卒中不可避免地破坏了许多神经元，但同时大脑也拥有惊人的可塑力，通过精准电刺激与大脑神经振荡——特别是与β节律（13～30Hz）的同步，可以有效触发大脑可塑性的重构。以Brain Interchange One为基础的创新康复疗法能够以特定电刺激来激发大脑神经“可塑性”，即大脑终身成长的底层机制，通过重新连接大脑皮质的神经网络来补偿并复原缺失的功能，例如恢复卒中患者的手部能力等。具体而言，Brain Interchange One分为内部单元和外部单元。其中内部单元为植入电极和配套电子设备，用于放大、过滤和数字化脑电信号并提供电刺激；外部单元分为无线磁吸供电设备、无线通讯设备以及计算机。通信单元一般绑在患者的上臂或轮椅上；外部计算机则用于分析处理数据、决定刺激模式，并将命令发送至植入物。 Brain Interchange One 图源：cortec-neuro.com 几十年前诞生的初代“脑起搏器”，通过持续不断地刺激大脑的特定区域来治疗脑疾病，但无论患者状况如何变化，“脑起搏器”均以固定模式运作。这种“单向”治疗方式无法灵活及时地应对患者日常病情波动，因此治疗效果有时并不尽如人意，并常伴有副作用。 Brain Interchange One所构建的闭环系统旨在不断地对患者身体反馈进行监测，独立地分析收集到数据，分析大脑活动，并据此精确计算后，实施个性化的电刺激治疗，即使刺激模式能够智能化地动态适应患者的即时需求。这种闭环疗法可为患者带来更为精准化、个性化的治疗方案，规避不必要刺激所引发的副作用。这也是为什么CorTec CEO兼创始人Jörn Rickert博士曾在公开采访中表示：“相较于Neuralink，CorTec的技术产品更进一步，因为CorTec的技术已经过广泛测试并已批量生产。” 源自高校的科研成果转化，单价数百美金并已完成量产 CorTec最早起源于德国弗赖堡大学的科研成果，目前拥有员工约60人，于2016年完成了B轮融资。在向市场推出植入式电极产品前，团队已有约十年的研究基础。2019年CorTec正式获得了美国FDA的批准，并按照ISO 14644-1标准建立了洁净车间，产品也取得了ISO13485认证。 CorTec洁净车间图源：cortec-neuro.com 作为全面的植入式脑机接口供应商，CorTec的各类植入式电极以及配套设备可在Chamfr Shop进行公开获取，单价从几百美元到上千美元不等。 CorTec的闭环解决方案也被用于开发新神经疗法的大量项目中，如大脑的神经系统疾病如癫痫、阿尔茨海默病、精神分裂症和抑郁症等，甚至是糖尿病。在糖尿病管理中，颈动脉体的作用尤为关键。研究表明，当颈窦神经——这些感受器的神经通路被切断时，身体调节低血糖的能力会受到影响，导致低血糖症的风险增加。葛兰素史克、谷歌联合创办的Galvani Bioelectronics与里斯本大学合作，利用CorTec的AirRay柔性袖带电极，对颈窦神经中的信号进行了精细的电生理监测。研究结果揭示，胰岛素及其引起的低血糖状态能够激活颈窦神经，进而激发交感神经系统，引发一系列生理反应，包括呼吸频率的增加、心率和血压的显著变化。在CorTec支持下，颈动脉有望成为治疗糖尿病、心血管疾病等众多疾病的“新靶点”，造福更多患者。类似的合作案例在CorTec官网还有很多，正如CorTec给自己的定位一样“To enable communication with the nervous system – for the cure of diseases”。脑机接口未来的市场潜力已无需赘述，在底层工具支持下，脑科学研究将逐渐提速，未来越来越多的疾病也将被治愈或被更好地治愈，但我们也不能忘记，如何使脑机接口及其疗法普及普惠，促进行业的共同繁荣，而不是“曲高和寡”，这才是科学研究最初也是最终的目的，即造福更多患者。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

临床研究

2024-05-24

·BioSpace

Foundation Medicine Announces Details of Over 20 Presentations at the 2024 ASCO® Annual Meeting

New research demonstrates the emerging applications of Foundation Medicine’s liquid biopsy and monitoring portfolio Additional research investigates new biomarkers and highlights the expanding utility of comprehensive genomic profiling (CGP), including RNA sequencing BOSTON--(BUSINESS WIRE)-- Foundation Medicine, Inc., today announced that 22 new pieces of research from its robust oncology diagnostics portfolio will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago. Emerging Applications of Liquid Biopsy Using FoundationOne®Liquid CDx and FoundationOne®Tracker Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer (Abstract #1042) Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO (Abstract #TPS3644) Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract #5020) Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC) (Abstract #5085) BRCA1/2 reversion mutations (BRCArev) in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy (Abstract #5056) Utility of CGP in Earlier Stages of Disease, Rare Cancers, and Using RNA Sequencing Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial (Abstract #8068) Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel (Abstract #5091) On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers (Abstract #3127) New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction (Abstract #11545) New CGP Biomarkers, Including Homologous Recombination Deficiency (HRD) Signature and Methyl Thioadenosine Phosphorylase (MTAP) Genomic Loss Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx) (Abstract #591) Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors (Abstract #3129) Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors (Abstract #3067) Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): Co-occurrence and prevalence along treatment course (Abstract #1060) Impact of Ancestry on the Genomic Alteration Landscape Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC) (Abstract #4138) Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes (Abstract #5614) “Our data at this year’s ASCO annual meeting reflects Foundation Medicine’s progress in making genomic profiling indispensable to cancer care and research, particularly in lung, breast and prostate cancers where there is an increasing number of targeted therapies for health care providers to consider for these patients,” says Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. “We are also excited to demonstrate our new RNA sequencing capabilities and spotlight the expanding utility of ctDNA to inform treatment decision making through a simple blood sample.” The following is a complete list of Foundation Medicine abstracts that will be presented. To access the abstracts being presented at ASCO, please visit ASCO.org/abstracts. Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO24 and visit us in person at Booth #22031. Abstract # Title Collaborator Products Posters Abstract #3127 6/1/2024 9:00 AM- 12:00 PM On the right TRACK: Providing comprehensive genomic profiling (CGP) and molecular tumor board (MTB) for patients (pts) with rare cancers TargetCancer Foundation, UC San Diego Moores Cancer Center, University of California, San Diego, Medical College of Wisconsin (MCW) Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins Hospital, The University of Texas MD Anderson Cancer Center, Department of Pharmacy, Rutgers New Jersey Medical School, Medication Acquisition, Inc., Sarah Cannon Research Institute, University of Nebraska, WIN Consortium for Precision Medicine FoundationOne®CDx FoundationOne®Liquid CDx Abstract #3129 6/1/2024 9:00 AM- 12:00 PM CDT Characterization of diverse targetable ERBB2 alterations in 512,993 patients with solid tumors Memorial Sloan Kettering Cancer Center FoundationOne®CDx FoundationOne®Liquid CDx Abstract #4138 6/1/2024 1:30 PM- 4:30 PM CDT Genetic ancestry-associated differences in genomic profiling and treatment patterns in pancreatic ductal adenocarcinoma (PDAC) Yale Cancer Center, New York University Perlmutter Cancer Center FoundationOne®CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) Abstract #TPS3644 6/1/2024 1:30 PM- 4:30 PM CDT Use of circulating tumor DNA (ctDNA) to affect the adjuvant or post-adjuvant treatment of patients with stage III and high-risk stage II resected colon cancer: The ERASE-CRC project by GONO University of Pisa, Italy FoundationOne®Tracker Abstract #11545 6/1/2024 1:30 PM- 4:30 PM CDT New soft tissue sarcoma (STS) transcriptomic clusters to unveil STS subsets with unique biological characteristics and refine the accuracy of overall survival (OS) prediction Universitario Lisboa Norte, Institute Portugues de Oncologia de Lisboa Francisco Gentil, Institute Superior Tecnico, Universidade de Lisboa, Institute de Medicina Molecular Joao Lobo Antunes, Faculdade de Medicina da Universidade de Lisboa, F. Hoffmann-La Roche AG, Institute Superior Tecnico (1ST), Universidade de Lisboa, Hospital CUF Descobertas FoundationOne®RNA for research use Abstract #3067 6/1/2024 9:00 AM- 12:00 PM CDT Nature and distribution of methyl thioadenosine phosphorylase (MTAP) genomic loss in human tumors San Raffaele Hospital and Scientific Institute, Italy FoundationOne® FoundationOne®CDx Abstract #1060 6/2/2024 9:00 AM- 12:00 PM CDT Genomic alterations (GA) in ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) patients (pts) with metastatic breast cancer (MBC): co-occurrence and prevalence along treatment course Emory University FoundationOne®CDx FoundationOne®Liquid CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) Abstract #591 6/2/2024 9:00 AM- 12:00 PM CDT Pathological complete response (pCR) association with a novel homologous recombination deficiency HRD signature (HRDsig) in patients with triple-negative breast cancer (TNBC) receiving neoadjuvant therapy (Tx) Stanford University FoundationOne®CDx Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) Abstract #5056 6/2/2024 9:00 AM- 12:00 PM CDT BRCA1/2 reversion mutations in advanced prostate cancer in the absence of prior PARP inhibitor (PARPi) therapy Cedars-Sinai Medical Center, Upstate University Medical Center, University of California - San Diego FoundationOne®Liquid CDx Abstract #1042 6/2/2024 9:00 AM- 12:00 PM CDT Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer Johns Hopkins University School of Medicine, Vanderbilt University Medical Center, Allegheny Health Network, Weill Cornell Medicine and New York-Presbyterian Hospital FoundationOne®Liquid CDx Abstract #5091 6/2/2024 9:00 AM- 12:00 PM CDT Impact of alterations in tumor suppressor genes (TSG-alt) on survival outcomes in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC) receiving androgen deprivation therapy (ADT) with androgen receptor pathway inhibition (ARPI) or docetaxel Huntsman Cancer Institute, Masonic Cancer Center Flatiron Health-Foundation Medicine Clinico-Genomic Database (CGDB) Abstract #5085 6/2/2024 9:00 AM- 12:00 PM CDT Prognostic value of baseline circulating tumor DNA (ctDNA) tumor fraction (TF) in metastatic hormone-sensitive prostate cancer (mHSPC) Rogel Comprehensive Cancer Center, University of Michigan, Karmanos Cancer Institute, Wayne State University FoundationOne®Liquid CDx Abstract #5020 6/2/2024 9:00 AM- 12:00 PM CDT Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) Peter MacCallum Cancer Centre, Department of Medical Oncology, Institut Gustave Roussy, University of Paris-Saclay, Pfizer Inc., National Cancer Center Hospital East, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, The Urology Center of Colorado, National Cancer Center, Tom Baker Cancer Centre, University of Calgary, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Huntsman Cancer Institute (NCI-CCC), University of Utah FoundationOne®Liquid CDx FoundationOne®Monitor for Research Use Abstract #3626 6/2/2024 9:00 AM- 12:00 PM CDT Contrasting comprehensive genomic profiles of adenocarcinomas of the appendix in younger versus older patients Upstate Medical University FoundationOne® FoundationOne®CDx Abstract #4588 6/2/2024 9:00 AM- 12:00 PM CDT FGFR3-mutated urothelial carcinoma of bladder and upper tract including ureter and renal pelvis: A comparative genomic profiling study Upstate Medical University, University of California – Los Angeles, University of Washington, Huntsman Cancer Center, Moffitt Cancer Center, MD Anderson Cancer Center, Cleveland Clinic, San Rafael University FoundationOne® FoundationOne®CDx Abstract #8032 6/2/2024 9:00 AM- 12:00 PM CDT Retrospective analysis of change in frequency of STK11 mutation in lung adenocarcinomas over a 10-year period Upstate Medical University FoundationOne® FoundationOne®CDx Abstract #1092 6/2/2024 9:00 AM- 12:00 PM CDT Impact of HER2 low status on genomic signatures in triple negative breast cancer (TNBC) Yale University FoundationOne® FoundationOne®CDx Abstract #11575 6/2/2024 9:00 AM- 12:00 PM CDT Intimal sarcomas (ISarc) of the cardiac chambers (CC) of the heart and great vessels (GV): A comprehensive genomic profiling (CGP) study Upstate Medical University FoundationOne® FoundationOne®CDx Abstract #6036 6/2/2024 9:00 AM- 12:00 PM CDT Clinical, molecular, and immunologic profiling of brain metastases (BM) in head and neck squamous cell carcinoma (HNSCC) Dana-Farber Cancer Institute, University of California – San Diego, Phase Genomics Abstract #5614 6/3/2024 9:00 AM- 12:00 PM CDT Endometrial cancer (EC) by ERBB2 amplification (ERBB2amp) status: Differences in molecular subtypes, ancestry, and real-world outcomes University of Colorado Health, Mount Sinai FoundationOne®CDx Abstract #8068 6/3/2024 1:30 PM- 4:30 PM CDT Preliminary results of the Lung Cancer Mutation Consortium LCMC4 evaluation of actionable drivers in early-stage lung cancer (LEADER) screening trial Baylor College of Medicine, Harvard University, University of Michigan, University of Missouri, University of Washington, University of California – Los Angeles, University of Colorado, Memorial Sloan Kettering FoundationOne®CDx FoundationOne®Liquid CDx Abstract #8532 6/3/2024 1:30 PM- 4:30 PM CDT Molecular profiling across histologies in lung cancer: Time to change WHO nomenclature? Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, Papardo Hospital, Roche Sequencing Solutions FoundationOne®CDx Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc. About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on and follow us on LinkedIn and X. About FoundationOne®CDx FoundationOne®CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit . About FoundationOne®Liquid CDx FoundationOne®Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit . About FoundationOne®Tracker FoundationOne®Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. FoundationOne Tracker is performed exclusively as a laboratory service and has not been cleared or approved by the U.S. Food and Drug Administration. For technical specifications, please visit FoundationMedicine.com. About FoundationOne®RNA FoundationOne®RNA is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne RNA has not been cleared or approved by the U.S. Food and Drug Administration. FoundationOne RNA is a test for solid tumors which utilizes RNA sequencing to interrogate 318 cancer-related genes to capture gene fusions and rearrangements. A negative result does not rule out the presence of an alteration. Genomic findings are not prescriptive or conclusive for labeled use of any specific therapeutic product. View source version on businesswire.com: Contacts Holly Campbell, 480-213-8368 newsroom@foundationmedicine.com Source: Foundation Medicine View this news release online at:

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