This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer. Using tumor tissue, a personalized blood test (the Invitae Personalized Cancer MonitoringTM test) will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA (ctDNA). The presence of residual cancer cells after treatment is known as molecular residual disease (MRD) and the detection of ctDNA can provide evidence of the presence of MRD. Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study.

开始日期2022-11-01

申办/合作机构

Invitae Corp.

[+1]

NCT05416710 / RecruitingN/A

Prospective Community Cancer Clinics-based Approach to Optimize Germline Testing in Cancer Patients in Rural Setting to Address Racial Disparities: UNIversal Germline Testing in the communitY (UNITY) Study

This study seeks to enroll participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms.

开始日期2022-06-01

申办/合作机构

Invitae Corp.

NCT04985266 / Recruiting临床2期IIT

A Randomised Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer

Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy. This trial will aim to demonstrate that palbociclib and fulvestrant, can defer or prevent relapse in patients with ctDNA detected molecular relapse.
The TRAK-ER trial will have two phases, a ctDNA surveillance phase and a randomised therapy trial in patients with positive ctDNA.
The TRAK-ER trial will establish a ctDNA screening programme for patients with ER positive breast cancer receiving adjuvant endocrine therapy with at least a further three years of standard adjuvant endocrine therapy planned. Patients recruited into the TRAK-ER study will have high-risk clinical features to identify patients at higher risk of future relapse.
ctDNA assays will be used to identify which people are at very high risk of relapse (i.e. those with a positive ctDNA result), and randomise this high risk population between standard endocrine therapy versus palbociclib plus fulvestrant for up to two years.

开始日期2022-03-30

申办/合作机构

Royal Marsden NHS Foundation Trust

[+6]

100 项与 Invitae Corp. 相关的临床结果

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0 项与 Invitae Corp. 相关的专利（医药）

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157

项与 Invitae Corp. 相关的文献（医药）

2024-10-01·World Journal of Oncology

Patterns and Frequency of Pathogenic Germline Variants Among Prostate Cancer Patients Utilizing Multi-Gene Panel Genetic Testing.

Article

作者: Alzibdeh, Abdulla ; Nielsen, Sarah M ; Esplin, Edward D ; Heald, Brandie ; Abu Hijlih, Ramiz ; Ghanem, Rami ; Al-Masri, Yosra ; Al-Batsh, Tamer ; Abdel-Razeq, Hikmat ; Bani Hani, Hira ; Salah, Samer ; Sharaf, Baha

Background:

Germline genetic testing (GGT) has significant implications in the management of patients with prostate cancer (PCa). Herein, we report on patterns and frequency of pathogenic/likely pathogenic germline variants (P/LPGVs) among newly diagnosed Arab patients with PCa.

Methods:

Patients meeting the National Comprehensive Cancer Network (NCCN) eligibility criteria for GGT were offered a 19-gene PCa panel or an expanded 84-gene multi-cancer panel.

Results:

During the study period, 231 patients were enrolled; 107 (46.3%) had metastatic disease at diagnosis. In total, 17 P/LPGVs were detected in 17 patients (7.4%). Among the 113 (48.9%) patients who underwent GGT with the 19-gene panel, eight (7.1%) had P/LPGVs, compared to nine (7.6%) of the 118 (51.1%) who did GGT through the expanded 84-gene panel (P = 0.88). Variant of uncertain significance (VUS) rate was higher (n = 73, 61.9%) among the group who underwent expanded 84-gene panel testing compared to those who underwent the 19-gene PCa panel (n = 35, 30.9%) (P = 0.001). P/LPGVs in DNA damage repair (DDR) genes, most frequently BRCA2, CHEK2 and TP53, were the most common P/LPGVs findings.

Conclusion:

This study is the first to characterize the germline genetic profile of an Arab population with PCa. All detected P/LPGVs were potentially actionable, with most variants able to be detected with a PCa-specific panel.

2024-10-01·World Journal of Oncology

Multi-Gene Panel Testing for Hereditary Cancer Predisposition Among Patients Sixty-Five Years and Above Diagnosed With Breast Cancer.

Article

作者: Al-Azzam, Khansa ; Bani Hani, Hira ; Nielsen, Sarah M ; Esplin, Edward D ; Hatchell, Kathryn E ; Heald, Brandie ; Tamimi, Faris ; Sharaf, Baha ; Alkyam, Mais ; Abdel-Razeq, Hikmat ; Mustafa, Rawan ; Al-Atary, Areej

Background:

The availability and affordability of germline genetic testing (GGT) has resulted in a broader utilization in daily clinical practice. However, adherence to testing guidelines is low, especially among older patients, where testing is often not offered.

Methods:

In this study, consecutive, newly diagnosed patients with breast cancer (BC) aged ≥ 65 years and eligible for GGT, as per the National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2021), were invited to participate, from March 2021 to December 2022. Patients were offered a restricted (two- or 20-gene panel), or an expanded 84-gene panel.

Results:

During the study period, 204 patients were enrolled. The mean (standard deviation (SD)) age at BC diagnosis was 70.5 (5.13) years, ranging 65 - 81 years. All patients were Arab and the majority were Jordanian. The majority (n = 188, 92.2%) had early-stage (stages I and II) disease. One hundred three (50.5%) patients were tested with a restricted two-gene (n = 13) or 20-gene (n = 90) panel, while the remaining 101 (49.5%) patients had an expanded 84-gene panel. Family history of close blood relative(s) with BC was the most common indication for testing (n = 110, 53.9%). Among the entire study cohort, 22 (10.8%) had pathogenic/likely pathogenic germline variants (PGVs) and another 97 (47.5%) had ≥ 1 variants of uncertain significance (VUS). PGV rates were significantly higher with the expanded panel (14.9%) compared to restricted testing (6.8%) (P = 0.032). Similarly, VUS rates were significantly higher with the expanded panel (64.4%) compared to the restricted panel (31.1%) (P < 0.001). The most prevalent genes with PGVs were BRCA1/2 (31.3% of all PGV-positive patients), CHEK2 (23.1%) and ATM (19.2%).

Conclusion:

GGT should not be overlooked in older BC patients, as this study demonstrates that > 10% of patients have PGVs, largely in potentially actionable genes.

2024-09-17·AMERICAN JOURNAL OF HUMAN GENETICS

Specifications of the ACMG/AMP variant curation guidelines for the analysis of germline ATM sequence variants.

Article

作者: Holdren, Megan ; Richardson, Marcy E ; McNulty, Shannon ; Pesaran, Tina ; Slavin, Thomas ; Walker, Logan C ; Anderson, Michael J ; Schon, Katherine ; Cline, Melissa ; Turnbull, Clare ; Brannan, Terra ; Zec, Lauren ; Hiraki, Susan ; Foulkes, William D ; Monteiro, Alvaro N ; de la Hoya, Miguel ; Tavtigian, Sean V ; Tischkowitz, Marc ; Young, Colin C ; Spurdle, Amanda B ; Couch, Fergus J

The ClinGen Hereditary Breast, Ovarian, and Pancreatic Cancer (HBOP) Variant Curation Expert Panel (VCEP) is composed of internationally recognized experts in clinical genetics, molecular biology, and variant interpretation. This VCEP made specifications for the American College of Medical Genetics and Association for Molecular Pathology (ACMG/AMP) guidelines for the ataxia telangiectasia mutated (ATM) gene according to the ClinGen protocol. These gene-specific rules for ATM were modified from the ACMG/AMP guidelines and were tested against 33 ATM variants of various types and classifications in a pilot curation phase. The pilot revealed a majority agreement between the HBOP VCEP classifications and the ClinVar-deposited classifications. Six pilot variants had conflicting interpretations in ClinVar, and re-evaluation with the VCEP's ATM-specific rules resulted in four that were classified as benign, one as likely pathogenic, and one as a variant of uncertain significance (VUS) by the VCEP, improving the certainty of interpretations in the public domain. Overall, 28 of the 33 pilot variants were not VUS, leading to an 85% classification rate. The ClinGen-approved, modified rules demonstrated value for improved interpretation of variants in ATM.

201

项与 Invitae Corp. 相关的新闻（医药）

2024-10-24

·PRNewswire

Labcorp Announces 2024 Third Quarter Results

Updates Full-Year Guidance Results from Continuing Operations for third quarter 2024 versus last year: Revenue: $3.28 billion versus $3.06 billion Diluted EPS: $2.00 versus $2.11 Adjusted EPS: $3.50 versus $3.38 Free Cash Flow: $162 million versus $171 million Updated Full-Year 2024 Guidance: Revenue range of 6.6% to 7.3%; midpoint unchanged Adjusted EPS range of $14.30 to $14.70; midpoint down $0.10, due to the negative impact from weather of approximately $0.15 Free Cash Flow of $850 million to $980 million Announced three new acquisitions/lab management agreements, and closed two acquisitions during the quarter that support growth initiatives BURLINGTON, N.C., Oct. 24, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced results for the third quarter ended September 30, 2024 and updated full-year guidance. "Labcorp achieved strong performance in Diagnostics and Biopharma Laboratories, including robust organic growth in the third quarter," said Adam Schechter, chairman and CEO of Labcorp. "Our results demonstrate momentum in our core businesses as we introduced new tests, and extended our leadership position in specialty testing. We announced or completed several transactions with health systems and regional/local laboratories, which aligns with our acquisition strategy. We are on track to finish 2024 with strong growth as we focus on science, technology, and innovation and bring new tests and services to our customers." Labcorp advanced key growth initiatives that supported its strategy: Announced an agreement to acquire select operating assets of Ballad Health's outreach lab services, expanding the company's laboratory and testing capabilities to rural communities in Tennessee, Virginia, North Carolina and Kentucky. Entered into a strategic collaboration with Naples Comprehensive Healthcare in Southwest Florida to manage the daily operations of its inpatient lab operations. Signed a new agreement to acquire select assets of Lab Works, an independent clinical laboratory located in Alabama. Closed the previously announced acquisition of select assets of BioReference Health's laboratory testing business. Completed the acquisition of select assets of Invitae ("Invitae"), extending Labcorp's leadership in specialty testing and ability to utilize genetic data to improve clinical trials and treatment regimens in oncology and select rare diseases. The company continues to make strides in science, technology, and innovation: Announced an expanded collaboration with Ultima Genomics to utilize its UG 100TM sequencing solution and ppmSeqTM technology to explore new whole genome sequencing clinical applications, including MRD in patients with early-stage solid tumor cancers. Received De Novo marketing authorization from the FDA for PGDx elio plasma focus Dx, the industry's only kitted, pan-solid tumor liquid biopsy test. Expanded Labcorp OnDemand offerings with additional consumer-initiated tests, including Syphilis and Luteinizing Hormone tests. Introduced a new Order Tracker Experience for Diagnostics customers, offering the majority of providers real-time visibility of test order status. Announced the expansion of its women's health solutions to include a personalized, comprehensive Postpartum Experience, through Ovia Health by Labcorp. Subsequent to the quarter, announced an exclusive agreement with NowDiagnostics (NOWDx) to distribute the first over-the-counter, point-of-care Syphilis blood test granted marketing authorization by the FDA. On October 10, 2024, Labcorp announced a quarterly cash dividend of $0.72 per share of common stock, payable on December 13, 2024, to stockholders of record at the close of business on November 26, 2024. Capital Allocation Summary At the end of the quarter, Labcorp's cash balance was $1.52 billion and total debt was $6.75 billion. The higher balances are due to Labcorp's financing activities to pre-fund maturing debt, over the next four months. During the quarter, the company invested $458.1 million on acquisitions, paid out $60.5 million in dividends, and used $75.0 million for share repurchases. Outlook for 2024 Labcorp is updating 2024 full year guidance to reflect its third quarter performance and full year outlook. The following guidance assumes foreign exchange rates effective as of September 30, 2024, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends. Use of Adjusted Measures The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company's operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company's financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release. The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company's website at . Analysts and investors are directed to the website to review this supplemental information. A conference call discussing Labcorp's quarterly results will be held today at 9:00 a.m. ET and is available by registering at this link, which will provide a dial-in number and unique PIN to access the call. It is recommended that participants join 10 minutes prior to the start of the call, although participants may register and join at any time during the call. A live webcast of Labcorp's quarterly conference call on October 24, 2024, will be available at the Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through September 10, 2025. About Labcorp Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world. Learn more about us at . Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements with respect to (i) the estimated 2024 guidance and related assumptions, (ii) the spin-off of the company's Clinical Development and Commercialization Services business, now Fortrea Holdings Inc., (iii) the impact of various factors on operating and financial results, including the projected impact of the COVID-19 pandemic on the company's businesses, operating results, cash flows and/or financial condition, as well as global economic and market conditions, (iv) future business strategies, (v) expected savings, synergies and other benefits to the Company, customers or patients from acquisitions and other transactions and partnerships, and (vi) opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control, including without limitation: (i) the effect of recently completed holding company reorganization on the company's business generally; (ii) the failure to receive tax-free treatment with respect to the spin-off for U.S. federal income purposes; (iii) the impact of spin-off related items; (iv) potential difficulties with employee retention; (v) the trading price of the company's stock, competitive actions and other unforeseen changes and general uncertainties in the marketplace; (vi) changes in government regulations, including healthcare reform; (vii) customer purchasing decisions, including changes in payer regulations or policies; (viii) other adverse actions of governmental and third-party payers; (ix) changes in testing guidelines or recommendations; (x) federal, state, and local government responses to the COVID-19 pandemic, and the volume of COVID-19 Testing performed by the company; (xi) the impact of global geopolitical events; (xii) the effect of public opinion on the company's reputation; (xiii) adverse results in material litigation matters; (xiv) the impact of changes in laws and regulations applicable to the company; (xv) failure to maintain or develop customer relationships; (xvi) the company's ability to develop or acquire new products and adapt to technological changes; (xvii) failure in information technology, systems, or data security; (xviii) the impact of potential losses under repurchase agreements; (xix) adverse weather conditions; (xx) the number of revenue days in a financial period; (xxi) employee relations; (xxii) personnel costs; (xxiii) inflation; (xxiv) increased competition; and (xxv) the effect of exchange rate fluctuations. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward- looking statements. The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the company's other filings with the SEC. The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K, and subsequent Forms 10-Q, under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS". The consolidated revenue and adjusted segment operating income are presented net of intersegment transaction eliminations and other amounts not used in determining segment performance. Adjusted operating income and adjusted operating margin are non-GAAP measures. See the subsequent reconciliation of non-GAAP financial measures. SOURCE Labcorp Holdings Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

并购引进/卖出

2024-09-24

·循因缉药

Natera:专利诉讼我赢了！NeoGenomics:我跪还不行？

环球视野，深度视角各位亲爱的股东们，大家早上好中午好晚上好。昨天，文章忘了标原创了...大家理解下。毕竟上年纪了...另外那不是商稿，非要给钱也行。昨天，Natera和NeoGenomics的两份公告让人摸不着头脑。一个似乎赢了，又不像真的赢了。有个似乎输了，又不像真的输了。呃，薛定谔来了高低得敬一杯... #01 Natera：我赢了！ 2024年9月23日，美国液态活检领域的大佬Natera发布公告更新其与NeoGenomics的专利纠纷进展。 Natera表示，宣布北卡罗来纳州中区地方法院对NeoGenomics的RaDaR检测法颁发了永久禁令。在此之前，美国专利商标局拒绝了NeoGenomics对本案所涉及的454专利的有效性挑战。这事，怎么看都是Natera赢。 MRD专利战风云再起！Natera诉NeoGenomics RaDaR专利侵权这事咱们在去年就跟踪报道过，感兴趣的小伙伴点击上面了解详情。懒得动弹的，我再复述一下。 2023年7月31日，Natera宣布起诉NeoGenomics，指控NeoGenomics侵犯了公司专利，涉及专利号为11,519,035/11,530,454。该两项专利，主要涉及MRD检测，而NeoGenomics的RaDaR检测不恰当的使用了这两项专利。 2023年12月27日，Natera宣布赢得了与NeoGenomics RaDaR MRD检测诉讼的专利禁令。一路赢过来，Natera专利和法务团队确实有两把刷子。然而，NeoGenomics表示：嘿嘿~ #02 NeoGenomics：嘿嘿同一日，被告NeoGenomics也发布了一份公告。 NeoGenomics高兴的宣布其RaDaR技术的新版本已通过可行性阶段，并且已解决与Natera关于RaDaR 1.0的诉讼。啊？怎么解决的？Natera真的知道吗？我觉得他不知道啊。 Natera在公告里可是明确表示：继续对RaDaR检测法的修改版本提起侵权诉讼。怎么着，您这给RaDaR套个2.0马甲，Natera就不敢告你了是咋地... 不存在啊... 仔细看下NeoGenomics的公告，哦，和解了。 But，保密。仔细看了下时间，我大概理了下。应该是禁令出来后，给NeoGenomics造成了压力。随后NeoGenomics给Natera展示了其新版RaDaR的原理，表示完全可以不依赖Natera的专利。然而Natera表示不care，继续专利战。随后，NeoGenomics服软，双方各退一步。内容的细节可能是： 1，交叉授权：以新技术交叉授权给Natera作为代价； 2，延期支付：前面Natera要求的侵权赔偿可能通过在后续产品销售中予以计提的方式而不是立即支付现金；以上两点纯属瞎猜，欢迎大佬们指正。 #03 关于RaDaR 所谓RaDaR，就是原来由Inivata（不是Invitae）开发，是一种tumor-informed MRD检测方案。使用WES确认患者个性化位点，据此再来开发个性化探针/引物，对后续ctDNA进行富集，检测MRD情况。根据公开资料，RaDaR检测的位点最多不超过48个，其LoD（limit of detection，最低检测限）低至0.001%的VAF. 2021年5月5日，NeoGenomics宣布收购Inivata，对价为3.9亿美元。 MRD专利战风云再起！Natera诉NeoGenomics RaDaR专利侵权感兴趣的可以去看看上面那篇，比较详细。 #04 最后这告诉我们一个道理，只要手里面的技术储备足够。就算跪，也跪的比较帅。受此消息影响，两家股票在盘后都有上涨。 Natera涨幅更大，似乎是投资人认为Natera赚了。真的吗？ END 啊对对对对，扫描这货能联系到我至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。近期文章：阅尔｜这家英国CTC公司决定从中国买个ctDNA检测 Ginkgo |爱（AI）与1775万美元的清净加钱加钱！Singular Genomics成了香饽饽 “七勇士”硬刚23andMe“霸道总裁” 相关资料：注1：https://investor.natera.com/news/news-details/2024/Court-Orders-Permanent-Injunction-Against-NeoGenomics-Accused-RaDaR-Assay-as-Case-Enters-New-Phase/default.aspx注2：https://ir.neogenomics.com/news-events/press-releases/detail/273/neogenomics-announces-new-radar-technology-and-resolution

专利侵权专利无效

2024-09-03

·PRNewswire

Global Gastric Cancer Diagnostics Market is Expected to Expand at a CAGR of ~7% by 2030 | DelveInsight

The increasing global incidence of gastric cancer is a major factor driving the demand for gastric cancer diagnostics. The market is also being fueled by the rising prevalence of GERD and other stomach-related conditions, along with the growing number of stomach infections such as H. Pylori and gastroenteritis. Additionally, the surge in obesity and smoking, which are linked to the development of stomach cancer, are significant contributors to the market's growth during the forecast period from 2024 to 2030. LAS VEGAS, Sept. 3, 2024 /PRNewswire/ -- DelveInsight's Gastric Cancer Diagnostics Market Insights report provides the current and forecast market analysis, individual leading gastric cancer diagnostics companies' market shares, challenges, gastric cancer diagnostics market drivers, barriers, trends, and key market gastric cancer diagnostics companies in the market. Key Takeaways from the Gastric Cancer Diagnostics Market Report As per DelveInsight estimates, North America is anticipated to dominate the global gastric cancer diagnostics market during the forecast period. In the product type segment of the gastric cancer diagnostics market, the reagents & kits category generated a significant revenue share in the gastric cancer diagnostics market in 2023. Notable gastric cancer diagnostics companies such as Abbott, BD, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Thermo Fisher Scientific Inc., Pillar Biosciences Inc., Hologic, Inc., CD Genomics, Natera, Inc., Biodesix, Illumina, Inc., Quest Diagnostics, Agilent Technologies, Inc., FUJIFILM Holdings Corporation, NeoGenomics Laboratories, Guardant Health, Myriad Genetics, Inc., Invitae Corporation, Danaher, and several others, are currently operating in the gastric cancer diagnostics market. In March 2024, AI Medical Service Inc. announced that it had launched gastroAI-model G, an AI-based endoscopic diagnostic support device that operates within the stomach. The diagnostic device operates by scanning for potential lesions, utilizing images derived from the video processor of the endoscopy system. Upon determining that a lesion appears suspicious for early gastric cancer and requires additional evaluation, the program notifies the physician and offers diagnostic support by presenting a highlighted area within the endoscopic display. In November 2023, Dedalus Group in collaboration with Ibex Medical Analytics, announced the launch of a fully integrated AI-powered digital pathology solution for gastric cancer diagnosis. In August 2023, Mirxes Pte Ltd announced that its flagship product GASTROClear, a PCR-based in vitro diagnostic test for early detection of gastric (stomach) cancer, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). It is a molecular blood test for the early detection of gastric cancer that helps to cure cancer with affordable treatment. To read more about the latest highlights related to the gastric cancer diagnostics market, get a snapshot of the key highlights entailed in the Global Gastric Cancer Diagnostics Market Report Gastric Cancer Diagnostics Overview Gastric cancer, or stomach cancer, is typically diagnosed through a combination of clinical evaluation, imaging techniques, and tissue biopsy. The diagnostic process often begins with a patient's history and physical examination, focusing on symptoms like persistent indigestion, weight loss, and abdominal pain. Imaging studies, such as upper gastrointestinal endoscopy, are crucial as they allow direct visualization of the stomach lining. During an endoscopy, a flexible tube with a camera is inserted through the mouth into the stomach, enabling doctors to identify suspicious lesions or tumors. Additional imaging techniques, such as computed tomography (CT) scans or positron emission tomography (PET) scans, may be used to determine the extent of the cancer and to detect possible metastasis to other organs. Confirming a diagnosis of gastric cancer requires a biopsy, where tissue samples are taken during an endoscopy and examined under a microscope for cancerous cells. Histopathological analysis of the biopsy helps determine the type and grade of the cancer, which is critical for guiding treatment options. Molecular testing on the biopsy sample can also identify specific genetic mutations or protein expressions, such as HER2, which may influence targeted therapy decisions. Blood tests for tumor markers like carcinoembryonic antigen (CEA) and CA 19-9 are sometimes used to support diagnosis or monitor treatment response, although these markers are not specific to gastric cancer. Early and accurate diagnosis is essential in improving the prognosis and survival rates for patients with gastric cancer. Gastric Cancer Diagnostics Market Insights In 2023, North America held the largest share of the gastric cancer diagnostics market. This dominance is attributed to the increasing prevalence of gastric cancer and related stomach diseases, along with the region's growing geriatric population and advancements in early cancer detection technologies. Data from the American Cancer Society, published in January 2024, predicts approximately 26,890 new cases of stomach cancer in the United States for 2024, with 16,160 cases among men and 10,730 among women. Stomach cancer accounts for about 1.5% of all new cancer diagnoses annually in the country. The higher incidence of gastric cancer among older adults is linked to age-related risk factors such as stomach infections and gastroesophageal reflux disease (GERD). As a result, the expanding elderly population is expected to drive the growth of the gastric cancer diagnostics market in the region. In March 2024, Ibex Medical Analytics launched Galen, an AI-powered diagnostic platform that offers accurate cancer diagnoses, reduces manual tasks, and is used for diagnosing gastric cancer, H. pylori, and other gastric lesions like adenoma and low-grade dysplasia. This increase in R&D activities by major players to develop advanced diagnostic solutions is expected to further boost the North American gastric cancer diagnostics market. To know more about why North America is leading the market growth in the gastric cancer diagnostics market, get a snapshot of the Gastric Cancer Diagnostics Market Outlook Gastric Cancer Diagnostics Market Dynamics The gastric cancer diagnostics market is evolving rapidly, driven by technological advancements, increasing awareness, and a growing focus on early detection. Gastric cancer, which remains one of the leading causes of cancer-related mortality worldwide, particularly in Asia and Eastern Europe, has led to a pressing need for improved diagnostic methods. Traditional diagnostic techniques like endoscopy and biopsy are now being complemented and, in some cases, replaced by innovative, non-invasive technologies such as liquid biopsy, molecular diagnostics, and advanced imaging techniques. These new modalities offer the potential for earlier detection, more accurate staging, and better monitoring of disease progression, which is critical for improving patient outcomes. A significant dynamic in the market is the integration of molecular diagnostics, including next-generation sequencing (NGS), which allows for the detection of specific genetic mutations and biomarkers associated with gastric cancer. These advancements are not only enhancing the precision of diagnosis but also paving the way for personalized medicine, where treatment can be tailored based on an individual's genetic profile. The push towards personalized medicine is further fueling the demand for diagnostic tools that can provide comprehensive genomic data, leading to an increase in partnerships between diagnostic companies and pharmaceutical firms aiming to develop targeted therapies. Furthermore, the rise of artificial intelligence and machine learning in diagnostics is another key trend shaping the gastric cancer diagnostics market. AI and ML are being integrated into imaging and pathology tools to improve the accuracy of cancer detection and reduce the chances of human error. These technologies can analyze large datasets, identify patterns, and make predictions that can assist clinicians in making more informed decisions. The growing adoption of AI-driven diagnostic platforms is expected to enhance the efficiency of gastric cancer screening programs and reduce the time required for diagnosis. The market is also influenced by the increasing prevalence of gastric cancer in aging populations, particularly in regions with high incidence rates. This demographic shift is expected to drive the demand for more accessible and cost-effective diagnostic solutions. Governments and healthcare organizations in these regions are investing in public health initiatives aimed at improving cancer screening and early detection rates, which is likely to further boost the market for diagnostic products and services. However, the market faces challenges, such as high costs associated with advanced diagnostic technologies and the need for specialized expertise to interpret complex diagnostic results. Additionally, disparities in healthcare infrastructure and access to advanced diagnostics between developed and developing regions may limit market growth in certain areas. Despite these challenges, the overall outlook for the gastric cancer diagnostics market remains positive, with continuous innovations and increasing emphasis on early detection poised to significantly impact the landscape in the coming years. Get a sneak peek at the gastric cancer diagnostics market dynamics @ Gastric Cancer Diagnostics Market Dynamics Analysis Gastric Cancer Diagnostics Market Assessment Gastric Cancer Diagnostics Market Segmentation Gastric Cancer Diagnostics Market Segmentation By Product Type: Instruments, Reagents & Kits Gastric Cancer Diagnostics Market Segmentation By Test Test: Imaging Test [Upper Endoscopy, Barium Swallow/X-Rays, CT Scan, Laparoscopy, MRI, Stomach Ultrasound, and Others], Laboratory Test [Biopsy, Blood Test, and Others] Gastric Cancer Diagnostics Market Segmentation By End Users: Hospitals, Diagnostic Laboratories, Academic & Research Institutes, Diagnostic Centers, and Others Gastric Cancer Diagnostics Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the gastric cancer diagnostics market are set to emerge as the trendsetter explore @ Gastric Cancer Diagnostics Companies Table of Contents Interested in knowing the gastric cancer diagnostics market by 2030? Click to get a snapshot of the Gastric Cancer Diagnostics Market Trends Related Reports Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including Hanmi Pharmaceuticals, Merck, Minneamrita Therapeutics, Taiho Pharmaceuticals, Bayer, among others. Gastric Cancer Pipeline Gastric Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key gastric cancer companies, including BeiGene, Linton Pharm Co. Ltd., RAPT Therapeutics, Leap Therapeutics, Idience, Bolt Biotherapeutics, Hubro Therapeutics, Immunocore, Ambrx, Hangzhou DAC Biotech, Beijing Immunoah Pharma Tech, Base Therapeutics, Nanjing KAEDI Biotech, HiberCell, Transcenta Holding, Suzhou Zelgen Biopharmaceuticals, Daiichi Sankyo, Ipsen, Alligator Bioscience, Bristol Myers Squibb, Jiangsu Hengrui Medicine, Shanghai Junshi Biosciences, ImmunoACT, among others. Gastroesophageal Reflux Disease Market Gastroesophageal Reflux Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key GERD companies, including Phathom Pharmaceuticals, Inc., Microbiome Health Sciences, Takeda, Braintree Laboratories, AstraZeneca, among others. Gastroesophageal Reflux Disease Pipeline Gastroesophageal Reflux Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key GERD companies, including Cinclus Pharma, Onconic Therapeutics, Renexxion, Addpharma, Trio Medicines, Chong Kun Dang Pharmaceutical, HK inno.N Corporation, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

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