Stage III Colon Cancer

AI-powered spatial analysis of tumor-infiltrating lymphocytes using Lunit SCOPE IO provides accurate prognosis prediction in stage II–III colon cancer SEOUL, South Korea, Nov. 27, 2023 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, published a new study in npj Precision Oncology (Nature Partner Journal), using Lunit SCOPE IO to predict prognosis in stage II–III colon cancer via AI-powered spatial analysis of tumor-infiltrating lymphocytes (TIL). This study showed that Lunit SCOPE IO and the power of AI for spatial TIL analysis can provide clinicians with a practical and efficient tool to enhance prognosis prediction. Continue Reading Lunit's AI-powered TIL analyzer, Lunit SCOPE IO Traditionally recognized as a biomarker that can be related to cancer prognosis, TIL densities in the tumor microenvironment (TME) offer valuable insights into the patient's immune response to the tumor. However, the manual evaluation of TIL densities has been laborious and time-consuming, even requiring additional steps in tissue preparation, such as special lymphocyte staining. Moreover, manual evaluation is prone to variability between observers. The study utilized Lunit SCOPE IO, Lunit's AI-powered hematoxylin and eosin (H&E) whole-slide image (WSI) analyzer, to evaluate intratumoral TIL (iTIL) and tumor-related stromal TIL (sTIL) densities from WSIs of 289 patients with stage II–III colon cancer treated with surgery and adjuvant therapy. Patients with confirmed recurrences showed significantly lower sTIL densities compared to those with no recurrence (mean sTIL density 630.2/mm2 in cases with confirmed recurrence vs. 1021.3/mm2 in no recurrence). The study also identified distinct risk groups: patients with the lowest iTIL and sTIL were grouped as high-risk, patients with higher sTIL than the median as low-risk, and intermediate-risk group. These groups were predictive of recurrence-free survival time and were independently associated with clinical outcomes after adjusting for other clinical factors. This result suggests that AI-powered TIL analysis can provide practical and reliable prognostic information for stage II–III colon cancer. "Despite progress in colon cancer treatments, we still see a relapse in about 20–30% of stage II–III patients. This underscores the need for more precise prognostic biomarkers," said Brandon Suh, CEO of Lunit. "With the integration of AI, Lunit's innovative approach not only simplifies the evaluation process but also holds the potential to guide treatment decisions and improve patient outcomes with a tailored approach." About Lunit Founded in 2013, Lunit is a deep learning-based medical AI company on a mission to conquer cancer. We are committed to harnessing AI to ensure accurate diagnosis and optimal treatment for each cancer patient using AI-powered medical image analytics and AI biomarkers. As a medical AI company grounded on clinical evidence, our findings are presented in major peer-reviewed journals, such as the Journal of Clinical Oncology and the Lancet Digital Health, and global conferences, including ASCO and RSNA. After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 3,000+ hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea, with offices and representatives worldwide. For more information, please visit lunit.io. About Lunit SCOPE Lunit SCOPE is a suite of AI-powered software that analyzes tissue slide images for digital pathology and AI biomarker development, aiming to optimize workflow and facilitate more accurate and predictive clinical data for clinicians and researchers. Lunit SCOPE platform offers multiple AI-powered tissue analysis products and assays that can streamline digital pathology workflow and diagnostics and enhance the drug development process. Lunit SCOPE IO analyzes the tumor microenvironment (TME) based on H&E analysis and provides AI-based predictive clinical outcome information. In addition, AI-driven Immunohistochemistry (IHC) slide analysis services are offered through products such as Lunit SCOPE PD-L1, Lunit SCOPE HER2, Lunit SCOPE ER/PR, and others. SOURCE Lunit

ROTTERDAM, Netherlands and SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- SkylineDx, an innovative molecular diagnostics company, is pleased to announce the forthcoming presentation of an impactful poster by Dr M.E. Egger at the upcoming Society for Melanoma Research Congress in Philadelphia. Dr. M.E. Egger's presentation promises to usher in a new paradigm in disease staging and management for cutaneous melanoma (CM) patients in the United States. This retrospective study included primary CM patients who underwent sentinel lymph node biopsy (SLNB) at six renowned medical institutions in the United States. The study investigated the performance of the Clinicopathologic and Gene Expression Profile (CP-GEP) model in their patient cohort. The patients were classified into two distinct categories: high risk and low risk for disease recurrence, offering critical insights into long-term prognosis. The study evaluated the 5-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and melanoma-specific-free survival (MSS) for both CP-GEP high-risk and low-risk patient groups. The analysis unveiled the CP-GEP model's pivotal role in effectively stratifying CM patients based on their risk of disease recurrence. According to Dr M.E. Egger, a leading surgical oncologist at the University of Louisville and UofL Health Brown Cancer Center: "These findings represent a significant step towards more precise risk assessment for CM patients, potentially allowing us to offer patient-tailored care to high-risk patients and providing insight into personalized surveillance strategies." SkylineDx's Chief Scientific Officer, Jvalini Dwarkasing, added: "The study's results are a testament to the CP-GEP model's potential in optimizing patient management strategies. This research further reinforces SkylineDx's commitment to advancing personalized medicine." The results revealed that CP-GEP low-risk patients exhibited substantially better long-term survival when compared to their high-risk counterparts, confirming the model's potential to identify a subgroup of Stage I/II CM patients at higher risk for disease recurrence. Furthermore, the CP-GEP model proved effective in stratifying Stage III CM patients into distinct low-risk and high-risk categories for disease recurrence. This outcome carries profound clinical implications, as it offers a refined approach to tailoring treatment strategies and surveillance protocols for melanoma patients. The analysis underscores the CP-GEP model's ability to serve as a valuable tool in improving risk stratification and long-term prognosis for cutaneous melanoma patients, potentially reshaping clinical decision-making in the United States. About SkylineDx SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit . SOURCE SkylineDx

Study results suggest Guardant RevealTM circulating tumor DNA blood test may help clinicians decide to pursue more or less aggressive post-surgical chemotherapy regimens PEGASUS is first clinical utility trial for tissue-free detection of minimal residual disease PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that initial results from the PEGASUS trial suggest liquid biopsy may be used in post-surgical clinical management to reduce unnecessary toxicity from chemotherapy and improve the response to standard chemotherapy regimens in patients with stage III or high-risk stage II colon cancer. Results from the trial, which is an ISS study sponsored by IFOM ETS – the AIRC Institute of Molecular Oncology in Milan, Italy, and supported by Guardant Health, were presented today by study investigators at the ESMO Congress in Madrid, Spain. One of the first prospective studies using liquid biopsy, the PEGASUS trial includes 135 patients recruited from 11 cancer centers in Italy and Spain. The study is assessing the feasibility of escalating or de-escalating adjuvant (post-surgery) chemotherapy based on the presence or absence of minimal residual disease (MRD) as indicated by circulating tumor DNA (ctDNA) detected by the Guardant Reveal blood test at multiple timepoints. Patients with positive results receive standard chemotherapy, while patients with negative results receive a milder therapy that is associated with significantly less acute and chronic neurological toxicity compared to standard treatment. Liquid biopsy is repeated several times along the course of treatment to reveal opportunities to treat patients safely with lower toxicity regimens, identify therapeutic resistance, and tailor chemotherapy to be stronger when needed. Initial results show that 34% of patients with a positive liquid biopsy result after surgery had the cancer return, while only 10% of patients with a negative result experienced a relapse. Approximately 40% of patients converted from ctDNA-positive to ctDNA-negative after treatment, suggesting treatment efficacy of chemotherapy for some patients. “We are confident that, once confirmed by the results of several other ongoing international studies on liquid biopsy, our findings may help influence the modification of clinical practice guidelines for the treatment of operable colon cancer, supporting adjuvant therapy scale-down or elimination in patients with negative liquid biopsy, and chemotherapy personalization in the case of molecular non-response,” said Silvia Marsoni, MD, PhD, the designer of the PEGASUS trial and head of the precision oncology unit at IFOM. “A shift from the current paradigm of one-size-fits-all chemotherapy toward a new paradigm of tailored therapies is not the only expected impact of the PEGASUS trial. It will allow us to explore the biology of micro-metastatic tumors, for which we need to find new and more effective therapies.” “Currently a significant number of patients with stage II and III colon cancer do not receive the intended benefit from adjuvant chemotherapy due to limits of current prognostic criteria. There is a significant need for better prognostic tools to guide clinical management in this patient population,” said Craig Eagle, MD, Guardant Health chief medical officer. “These initial trial results are promising and suggest that the Guardant Reveal liquid biopsy test can provide a sensitive tool to detect MRD and predict recurrence of the cancer, helping oncologists make informed treatment decisions that improve outcomes for their patients.” For more information about the PEGASUS study, visit: About Guardant Health Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY® tests for advanced stage cancer, and Guardant Reveal™ for early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter. 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, 2022, and any current and periodic 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. View source version on businesswire.com: Contacts Investor Contact: investors@guardanthealth.com Source: Guardant Health, Inc. View this news release online at: