The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

开始日期2025-09-01

申办/合作机构

Guardant Health, Inc.

NCT06444542

/ RecruitingN/AIIT

Understanding Patient Preference on Colorectal Cancer Screening Options

There are significant barriers to colorectal cancer screening within underserved populations due to the cost, accessibility, and acceptability of screening methods. Patient-friendly approaches that minimize stress and discomfort for the patient are needed to enhance screening compliance and achieve an early diagnosis. The primary aim of this study is to examine whether the availability of a blood-based screening option, which can be done at the point of service and is familiar to patients, will improve patient compliance to recommended CRC screening

开始日期2024-09-16

申办/合作机构

Hershey Medical Center

[+2]

JPRN-jRCT1050240085

/ RecruitingN/AIIT

MRD DETECTION AND LONGITUDINAL MONITORING OF MOLECULAR RECURRENCE USING GUARDANT REVEAL ASSAY IN LUNG CANCER PATIENTS WHO RECEIVE CURATIVE-INTENT LOCAL TREATMENTS

开始日期2024-07-05

申办/合作机构

Guardant Health, Inc.

100 项与 Guardant Health, Inc. 相关的临床结果

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0 项与 Guardant Health, Inc. 相关的专利（医药）

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419

项与 Guardant Health, Inc. 相关的文献（医药）

2025-04-21·Cancer Research

Abstract 6365: A novel methylation-based classifier to identify cancer signal of origin using blood based testing

作者: Raymond, Victoria M. ; Singer, Meromit ; Selewa, Alan ; Tung, Jack ; Chudova, Darya ; Forouzmand, Elmira ; Hoang, Theresa ; Talasaz, Amirali ; Tsai, Jill ; He, Yupeng ; Gittelman, Rachel

AbstractBackground:Accurate prediction of the cancer signal of origin (CSO) is crucial for blood-based cancer detection in order to guide subsequent diagnostic workups and select the appropriate therapeutic regimes. Here, we present feasibility data from a novel, methylation-based classifier which is able to differentiate the histological origin of 12 cancer types from a single blood-based screening assay.Method:We developed an algorithm on Guardant Infinity®, a next-generation sequencing platform evaluating cell free DNA from plasma samples, to predict the CSO of 12 cancer types (bladder, breast, colorectal, esophageal, kidney, liver, lung, ovarian, pancreatic, prostate, stomach, and uterine/endometrial). This algorithm uses two steps to predict CSO based on the DNA methylation signature of plasma cell-free molecules from >2000 cancer-specific differentially methylated genomic regions. First, a regression model (multi-cancer classifier) was trained using 701 cancer samples across 17 distinct cancer types and 10, 413 non-cancer samples to identify cancer samples with sufficient tumor-derived methylation signal. Next, a methylation-based CSO classifier was used to determine the CSO of samples called positive by the multi-cancer classifier. The CSO classifier was trained on 13, 856 cancer samples from 12 supported cancer types and 4, 142 non-cancer samples, and assessed on 1, 464 advanced cancer samples that were called cancer positive by the cancer detection classifier in the hold out set.Results:Among the 1464 detected cancer samples, 88.2% (1291 / 1464) were correctly classified by the CSO classifier with the top prediction, and 93.6% (1370 / 1464) were correctly classified with the top two predictions. To estimate the real-world performance of this algorithm, the accuracy of the CSO classifier for different cancer types were weighted by the cancer incidence rate in the US population and then aggregated. These adjusted accuracies of the top CSO prediction and top 2 CSO predictions are 88.5% and 93.0%, respectively.Conclusion:Herein, we demonstrate the capability of a novel, methylation-based algorithm to predict CSO with high sensitivity and accuracy from a plasma-based sequencing platform. Further clinical validation in early cancer detection and disease monitoring is needed.Citation Format:Elmira Forouzmand, Yupeng He, Rachel Gittelman, Alan Selewa, Meromit Singer, Jill Tsai, Theresa Hoang, Jack Tung, Victoria M. Raymond, Amirali Talasaz, Darya Chudova. A novel methylation-based classifier to identify cancer signal of origin using blood based testing [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 6365.

2025-04-21·Cancer Research

Abstract 4594: EGFR PACC mutations occur more frequently as compound mutations with better responses to EGFR TKIs

作者: Heymach, John V. ; Borgeaud, Maxime ; Zhang, Jianjun ; Weipert, Caroline ; Heeke, Simon ; Chen, Hong ; He, Junqin ; Stamboulian, Moses ; Lawson, John ; Nilsson, Monique B. ; Le, Xiuning ; Ravichandran, Ashwin ; Lewis, Courtney ; Alfredo, Addeo ; Zhu, Erjia ; Liu, Ximeng

AbstractEGFR mutations are key oncogenic drivers in NSCLC and can occur either as single or compound mutations. The frequency of classical (Ex19del and L858R) and non-classical PACC mutations in single and compound forms is not fully characterized, and the impact of single vs. compound EGFR mutations on drug sensitivity and clinical outcomes with EGFR TKIs remains unclear. We aimed to identify the effect of single and compound EGFR mutations to improve precision treatment and outcomes for EGFR-mutant NSCLC patients. We queried a circulating cfDNA sequencing database of de-identified NSCLC patients from Guardant Health and analyzed the incidences of EGFR mutations in single and compound forms. In this dataset, after excluding samples with T790M/C797S or Ex20ins, the most frequent classical mutations were Ex19del (6,670, 38.1%) and L858R (4,700, 26.9%), and the most frequent PACC mutations were G719X (712, 4.1%), S768X (335, 1.9%) and E709X (207, 1.2%). 84.22% of classical mutations occurred as single mutations, with Ex19del in 89.5% and L858R in 76.7% of samples, respectively. In contrast, 80.12% of PACC mutations occurred as compound mutations, with G719X in 73.2%, S768X in 86.9%, and E709X in 97.1% of samples. We engineered Ba/F3 cells to express single or compound PACC mutations and evaluated sensitivity to clinically available EGFR TKIs. Compound PACC mutants showed significantly increased sensitivity to 2nd-gen compared to 1st- and 3rd-gen TKIs. Cells with compound PACC mutations exhibited a tendency towards enhanced TKI sensitivity compared to cells with single mutations.Cells with single or compound G719X/E709X, single V769L and compound S768I/V769L were most sensitive to 2nd-gen TKIs. Cells with single S768I had the highest sensitivity to 3rd-gen TKIs. In a retrospective clinical data analysis we assessed treatment outcomes for patients with single or compound PACC mutations (n=1268). Patients with either form of PACC mutations showed the best response rates (RR) (single: 54.67%, compound: 70.34%) and longest mPFS (single: 9mo, compound: 15mo) with 2nd-gen TKIs. Compound PACC mutations were associated with better RRs and longer mPFS than single forms across all TKIs. Specifically, patients with G719X or E709X, regardless of mutation form, had the longest mPFS with 2nd-gen TKIs (single vs. compound: G719X:11.2 vs. 18.5mo, E709X: 10.9 vs. 8.9mo). Patients with single S768X showed the longest mPFS to 3rd-gen TKIs (13.25mo), differing from those with compound S768X, whose mPFS was the longest with 2nd-gen TKIs (8.9mo). Collectively, our analysis indicates that EGFR PACC mutations predominantly occur as compound mutations while classical mutations most frequently present as single mutations. Compound and single PACC mutations were associated with improved clinical responses to 2nd-gen EGFR TKIs.Citation Format:Ximeng Liu, Moses Stamboulian, Maxime Borgeaud, Ashwin Ravichandran, Caroline Weipert, Monique B. Nilsson, Erjia Zhu, Hong Chen, Courtney Lewis, Simon Heeke, Junqin He, John Lawson, Jianjun Zhang, Addeo Alfredo, John V. Heymach, Xiuning Le. EGFR PACC mutations occur more frequently as compound mutations with better responses to EGFR TKIs [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4594.

2025-04-01·ESMO Open

Detection of minimal residual disease and prediction of recurrence in breast cancer using a plasma-only circulating tumor DNA assay

Article

作者: Janni, W ; Mergel, F ; De Gregorio, A ; Dustin, D J ; Müller, V ; Uhl, N ; Huober, J ; Wiesmüller, L ; Friedl, T W P ; Fink, A ; Pfister, K ; Huesmann, S T ; Rack, B ; Hartkopf, A D ; Braun, T ; Zhang, S ; Rich, T A ; Fehm, T ; Mehmeti, F

BACKGROUNDDetection of minimal residual disease (MRD) in early breast cancer (EBC) after curative-intent treatment may identify patients at risk for recurrence. Most circulating tumor DNA (ctDNA)-based MRD assays require knowledge of genomic alterations from tumor tissue. However, tissue availability may be limited in some patients. Here, we evaluated sensitivity and specificity for recurrence detection, using a plasma-only ctDNA MRD assay.MATERIALS AND METHODSFor this pilot study, 47 plasma samples from 38 EBC patients were collected at 12 or 36 months post-diagnosis or at clinical recurrence. ctDNA presence was determined by a custom bioinformatics classifier that identifies tumor-derived somatic variants and methylation profiles specific to individual cancer types using a 5-Mb next-generation sequencing panel.RESULTSctDNA was detected at or before distant recurrence in 11/14 (79%) patients [sensitivity was 85% (11/13) among samples collected within 2 years from recurrence]. Lead time was evaluable in 4/6 (67%) samples collected before distant recurrence with detectable ctDNA and ranged from 3.4 to 18.5 months. ctDNA was not detected in samples from patients without recurrence (n = 13).CONCLUSIONSThis study demonstrates the feasibility of MRD detection in EBC using a plasma-only multiomic ctDNA-based approach. Larger studies are ongoing to further validate the clinical performance of the assay and demonstrate its applications.

273

项与 Guardant Health, Inc. 相关的新闻（医药）

2025-05-01

·循因缉药

Guardant Health 多癌早筛性能首秀

环球视野，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！看了一圈，没人写，咱们就随便聊聊。2025年2月，我们在分析Guardant Health 2024Q4财报的时候提到过Guardant Health多癌早筛的产品即将揭开神秘面纱。预计该公司将在2025Q2公布性能数据，如今他来了。2025年4月29日，在AACR 2025年会期间Guardant Health公布了一项在778例受试者的临床研究结果。该产品基于cfDNA甲基化检测技术，提供了10种癌症的早筛。总体敏感性60%，肿瘤溯源准确性89%。其中敏感性最弱的为前列腺癌，仅有21%。肿瘤溯源能力最弱的为肝癌，为73%。从敏感性上来看，似乎比GRAIL的Galleri要好。但是，GRAIL的数据来自更庞大的临床试验且包含更多的癌症类型。未来还要看Guardant Health更多的研究结果。另外。除了Guardant Health，Exact Sciences的MCED产品预计2025年下半年推出LDT版本。至此，三国战争即将拉开帷幕GRAIL会是那个起了个大早，赶了个晚集的人么？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：GeneDx：亏损、暴跌，但上调预期华大智造最新财报：咬定青山，一争长短Caribou Biosciences麻了！停管线，停临床前研发，再裁员32%NMPA WARNING：中国暂停印度VITAL LAB 地高辛原料药进口金域医学2024:哥们你是怎么做到的？真实的商战总是这么朴实无华且枯燥相关资料：注1：https://www.businesswire.com/news/home/20250429167731/en/Guardant-Health-Presents-Data-Demonstrating-Strong-Performance-of-Shield-Multi-Cancer-Detection-Test-Across-10-Tumor-Types注2：https://www.galleri.com/hcp/galleri-test-performance

AACR会议财报临床研究

2025-04-29

·Business Wire

Guardant Health Presents Data Demonstrating Strong Performance of Shield Multi-Cancer Detection Test Across 10 Tumor Types

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, presented data today from a study showing that its methylation-based Shield™ multi-cancer detection (MCD) test demonstrated high specificity and clinically meaningful sensitivity across ten tumor types,* while also providing information to guide clinical diagnostic evaluation. The study was presented at the 2025 American Association for Cancer Research (AACR) annual meeting. Results of the study served as the basis for the selection of the blood-based Shield MCD test by the National Cancer Institute (NCI) for inclusion in its upcoming Vanguard Study evaluating emerging MCD technology. "This strong data reinforces the potential of the Shield test to detect multiple cancers earlier through a simple blood draw." Data presented in the oral session titled “Evaluation of a plasma cell-free DNA methylation-based multi-cancer detection test” showed that the Shield MCD test demonstrated 98.5% specificity and 60% overall sensitivity, with 74% sensitivity across the six most aggressive cancers (defined as those with the shortest survival rates), including esophageal-gastric, hepatocellular, lung, ovarian and pancreas. The test also demonstrated 89% accuracy for primary or secondary cancer signal of origin (CSO) prediction. “There are still many types of cancer that are difficult to detect with existing technologies until the late stages. This strong data reinforces the potential of the Shield test to detect multiple cancers earlier through a simple blood draw,” said AmirAli Talasaz, Guardant Health co-founder and co-CEO. “This study was a critical step in evaluating this innovative technology as a new screening option we can bring to patients to help reduce cancer deaths.” The blinded case-control study evaluated samples from 778 individuals with either a known diagnosis of cancer or who were cancer free (by self-report). Age range of participants was 40-78 years (median age 62); 55% were female and 79% were white. Across the ten cancer types, overall sensitivity per type ranged from 96% (esophageal-gastric (stomach)) to 21% (prostate) at 98.5% specificity (Table 1). Table 1: Overall and per cancer Sensitivity and CSO Accuracy Results at 98.5% Specificity (n=403) Sensitivity, % Primary or Secondary CSO Accuracy, % Overall, 375 60% 89% Bladder, 13 62% 75% Breast, 86 45% 92% Colorectal, 41 83% 94% Esophageal-Gastric (Stomach) 25 96% 92% Hepatocellular, 16 94% 73% Lung, 57 67% 97% Ovarian, 20 70% 93% Pancreas, 59 68% 80% Prostate, 59 21% 83% “Impressively, this initial cohort analysis of the Shield MCD test met overall performance expectations, with particularly strong sensitivity in the six most aggressive cancers for which early detection is key,” said William Greenleaf, Ph.D., study co-author, consultant for Guardant Health and professor of genetics at Stanford University School of Medicine. “These results show this blood-based MCD test holds promise for detection of multiple cancer types, and thus for detection in asymptomatic adults when treatment is more effective.” The full data abstract and a list of all abstracts being presented at the meeting can be found on the AACR website. For more information on the NCI Vanguard Study, please visit the study website. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. * Esophageal and Gastric cancers are combined in Table 1.

临床结果AACR会议

2025-04-24

·循因缉药

Exact Sciences：如约杀向MRD，混战加剧

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好（联系方式在文末）。我们在分析Exact Sciences 2024Q4财报的时候跟各位汇报过，名为Oncodetect的MRD产品即将在2025Q2上市。如今，Exact兑现了当时的承诺。#01如约2025年4月22日，Exact Sciences正式宣布其MRD产品oncodetect上市。与我们此前报道基本一致，oncodetect基于tumor-informed路线。采用WES（Whole Exome Sequencing）进行基线检测，定制化探针包含50-200个位点。跟踪检测阶段cfDNA 投入量15-60ng，检测下限（LoD）0.005% TF（tumor fraction）。那么，这个0.005%的LoD是不是秒杀了Natera的0.01%呢？不见得。Oncodetect用的是tumor fraction（肿瘤细胞比例），而natera的signatera用的是VAF（variant allel frequency），不能直接对比。再等等看，也许用不了多久natera就忍不住开怼了。#02影响Exact的MRD产品会影响natera signatera的销量吗？短时间来看，可能有限。Signatera目前占据美国MRD市场绝对领先地位，2024Q4一个季度就卖了14.5万份。作为后来者，Exact需要打通医保、院端、医生和患者多个卡口。而Exact此前主要的资源是在肠癌早筛，其肿瘤治疗业务极少。2024Q4的数据来看，精准肿瘤业务占比大约1/4。另外，我们natera也并未坐以待毙。不仅通过WGS（全基因组测序）来加强自己的tumor-informed路线优势，还准备在2025中期（估计快了）推出tumor-naive路线的MRD产品。这意味着natera将成为唯一一个具备MRD全技术路线的美国上市企业，直接把Tempus、Labcorp、Myriad、Exact和Guardant Heath的全部产品纳入竞争对手范围。就...牛X。#03最后MRD这块肥肉，美国这些公司是不可能放过的。至于谁能走到最后，那确实不好说。从先手来看，Natera牢牢占据第一梯队。而Tempus有AI概念加持，Exact有肠癌早筛成功经验加持和强大的资金优势，老对手Guardant Health的tumor-naive路线经营多年。看起来，第二把交椅的争夺战还将白热化。另外，别忘了，GRAIL其实一直有MRD的储备哦...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：艾德生物2024：龙头也难“关税战”生命科学工具领域的众生相96新娘84郎，一树梨花压海棠特朗普新医改：集采、药品零加成和三分钱的胰岛素Illumina CEO一年薪酬竟不足1500万美元Quanterix和Akoya的命运将在2025年5月13日决定相关资料：注1：https://www.exactsciences.com/news-events/press-releases/exact-sciences-launches-the-oncodetect-molecular-residual-disease-test注2：https://www.exactsciences.com/news-events/press-releases/new-evidence-validates-oncodetect-s-ability-to-detect-molecular-residual-disease注3：https://www.exactsciences.com/cancer-testing/oncodetect-mrd-providers/

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100 项与 Guardant Health, Inc. 相关的药物交易

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100 项与 Guardant Health, Inc. 相关的转化医学

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