Latest news with #ClinicalBreastCancer
Yahoo
06-05-2025
- Health
- Yahoo
AI-Driven Accuracy and Efficiency in Breast Cancer Diagnosis: New Study Validates Ibex Breast Solution
Ibex Breast Study shows Ibex's AI boosts pathologists' diagnostic accuracy to 100% and shortens case review time BOSTON, May 06, 2025--(BUSINESS WIRE)--A newly published peer-reviewed article on a study conducted at The Ohio State University Wexner Medical Center confirms that Ibex Breast, an AI-powered diagnostic support solution developed by Ibex Medical Analytics (Ibex), significantly improves accuracy and efficiency in evaluating breast pathology cases. The findings, published in Clinical Breast Cancer, demonstrate how AI technology can assist pathologists in providing patients with quicker and more trusted diagnostic results. "This study represents a critical step forward in validating the role of AI in breast pathology," said Zaibo Li, MD, PhD, MBA, Department of Pathology at The Ohio State University Wexner Medical Center. "Our findings show that AI-powered tools can enhance diagnostic accuracy and improve workflow by reducing review times and additional testing." The study analyzed 104 real-world breast biopsies, including invasive and microinvasive carcinomas, ductal carcinoma in situ (DCIS), atypical lobular hyperplasia (ALH) and other benign lesions. Three expert breast pathologists independently reviewed each case digitally, both with and without the support of Ibex Breast. Results demonstrated a clear benefit: when using AI, diagnostic accuracy improved from 97.1% to 100%, with previously missed precancerous lesions, such as lobular neoplasia and microcalcifications, correctly identified. Pathologists using AI also experienced up to 23% reduction in review time and an average 33% decrease in immunohistochemistry (IHC) test orders; these more efficient workflows increase pathologists' productivity, reduce turnaround times, and ensure patients receive their diagnosis as soon as possible. Released in 2022, Ibex Breast detects more than 50 tissue morphologies - both malignant and benign - and has been widely adopted by leading pathology labs worldwide. The AI solution was trained and validated on a large and diverse collection of breast slides from laboratories around the world utilizing different digital scanner models. A global team of senior pathologists marked and labelled tissue morphologies, to ensure the AI's accuracy and the robustness of diagnostic support provided. By accurately classifying challenging lesions and supporting real-time diagnostic decisions, Ibex Breast delivers both clinical and operational value to pathology labs under pressure. "Beyond the numbers, Ibex Breast bolsters pathologists' confidence and peace of mind, especially when navigating complex or borderline cases. What this ultimately means is that patients can receive their diagnosis sooner – and that's absolutely critical in breast cancer, where time matters both medically and emotionally," said Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics.
Business Wire
06-05-2025
- Health
- Business Wire
AI-Driven Accuracy and Efficiency in Breast Cancer Diagnosis: New Study Validates Ibex Breast Solution
BOSTON--(BUSINESS WIRE)--A newly published peer-reviewed article on a study conducted at The Ohio State University Wexner Medical Center confirms that Ibex Breast, an AI-powered diagnostic support solution developed by Ibex Medical Analytics (Ibex), significantly improves accuracy and efficiency in evaluating breast pathology cases. The findings, published in Clinical Breast Cancer, demonstrate how AI technology can assist pathologists in providing patients with quicker and more trusted diagnostic results. 'This study represents a critical step forward in validating the role of AI in breast pathology,' said Zaibo Li, MD, PhD, MBA, Department of Pathology at The Ohio State University Wexner Medical Center. 'Our findings show that AI-powered tools can enhance diagnostic accuracy and improve workflow by reducing review times and additional testing.' The study analyzed 104 real-world breast biopsies, including invasive and microinvasive carcinomas, ductal carcinoma in situ (DCIS), atypical lobular hyperplasia (ALH) and other benign lesions. Three expert breast pathologists independently reviewed each case digitally, both with and without the support of Ibex Breast. Results demonstrated a clear benefit: when using AI, diagnostic accuracy improved from 97.1% to 100%, with previously missed precancerous lesions, such as lobular neoplasia and microcalcifications, correctly identified. Pathologists using AI also experienced up to 23% reduction in review time and an average 33% decrease in immunohistochemistry (IHC) test orders; these more efficient workflows increase pathologists' productivity, reduce turnaround times, and ensure patients receive their diagnosis as soon as possible. Released in 2022, Ibex Breast detects more than 50 tissue morphologies - both malignant and benign - and has been widely adopted by leading pathology labs worldwide. The AI solution was trained and validated on a large and diverse collection of breast slides from laboratories around the world utilizing different digital scanner models. A global team of senior pathologists marked and labelled tissue morphologies, to ensure the AI's accuracy and the robustness of diagnostic support provided. By accurately classifying challenging lesions and supporting real-time diagnostic decisions, Ibex Breast delivers both clinical and operational value to pathology labs under pressure. 'Beyond the numbers, Ibex Breast bolsters pathologists' confidence and peace of mind, especially when navigating complex or borderline cases. What this ultimately means is that patients can receive their diagnosis sooner – and that's absolutely critical in breast cancer, where time matters both medically and emotionally,' said Dr. Manuela Vecsler, VP of Clinical and Scientific Affairs at Ibex Medical Analytics. The increasing number of breast cancer cases and growing case complexity with advances in precision oncology, combined with a shortage of pathologists, makes Ibex Breast an essential tool for improving diagnostic consistency, reducing turnaround times, and alleviating the resource strain throughout the U.S. healthcare system. About Ibex Medical Analytics Ibex Medical Analytics is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering physicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex is the first and most widely deployed AI-powered platform in pathology. Pathologists worldwide use Ibex as part of their everyday routine to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times, and boost productivity with more efficient workflows. The Ibex platform includes solutions that are CE-IVD certified and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. It includes a solution that is FDA cleared and others that are Research Use Only (RUO) in the United States.
Yahoo
29-01-2025
- Health
- Yahoo
Sermonix Announces Clinical Breast Cancer Publication of Article Examining Effects of Lasofoxifene Versus Fulvestrant on Urogenital Symptoms in Patients with ESR1-Mutated ER+/HER2- Metastatic Breast Cancer
Lasofoxifene, but not fulvestrant, improved vaginal and vulvar symptoms in quality of life secondary endpoint analysis COLUMBUS, Ohio, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), today announced the publication of an article entitled 'Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study,' in the peer-reviewed journal Clinical Breast Cancer. The previously reported Phase 2 valuation of sofoxfee in SR1 Mutations (ELAINE-1) study (NCT03781063) was an open-label, randomized trial evaluating the efficacy and safety of lasofoxifene versus fulvestrant. In the study of women with ESR1-mutant breast cancer who previously had aromatase inhibitor-CDK4/6is, 52 women were randomized to lasofoxifene and 51 to fulvestrant, with progression-free survival (PFS) as the primary endpoint. Lasofoxifene monotherapy had numerically greater PFS (median 5.6 vs 3.7 months; P=0.138; hazard ratio [HR] 0.669 [95% CI, 0.434-1.125]), objective response rate (ORR, 13.2% vs 2.9%; P=0.124), and clinical benefit rate (CBR, 36.5% vs 21.6%; P=0.117) versus fulvestrant. The small sample size of this Phase 2, signal-seeking study limited the statistical power. A favorable safety profile was reported in both treatment groups.1 In this secondary endpoint analysis just published, patients treated with investigational lasofoxifene – but not fulvestrant – demonstrated improved vaginal and vulvar symptoms of dryness and pain as assessed by the validated vaginal and vulvar symptom scale (VAS and VuAS) patient-reported outcome instrument. 'Recent progress in breast cancer management is leading to improved patient outcomes and longevity. Sermonix is highly focused on advancing oral lasofoxifene to hopefully build on that progress and to potentially improve patient quality of life particularly around urogenital health, an issue important to many patients and couples coping with current breast cancer treatments,' said Dr. David Portman, Sermonix founder and chief executive officer. 'While lasofoxifene has been previously studied in healthy post-menopausal women with urogenital syndrome of menopause, it has not been explored in a population with advanced breast cancer. We are very pleased that Clinical Breast Cancer, a prestigious peer-reviewed journal, recognized the importance of the results from ELAINE-1 and the need for further research in this area.' Results: Of 103 enrolled patients, 72 (70%) completed the mean vaginal (VAS) and vulvar (VuAS) assessment scales (mean age 61.5 years). Vaginal (40%)/vulvar (25%) dryness and vaginal pain (22%) were the most frequently reported symptoms; 26% reported ≥1 moderate/severe symptom. Lasofoxifene decreased the mean composite VAS/VuAS, VAS, and VuAS from baseline to week 16 by 74%, 74%, and 79%, respectively, while fulvestrant increased them by 36%, 15%, and 63%, respectively. Baseline vaginal/vulvar symptoms were more severe if patients were under age 40, had no visceral disease, used adjuvant tamoxifen previously, or had a longer duration of AI use in the adjuvant/metastatic settings. The currently enrolling Phase 3, registrational, ELAINE-3 trial (NCT05696626) comparing the efficacy and safety of lasofoxifene plus abemaciclib to fulvestrant plus abemaciclib will incorporate the FACT B-Endocrine Symptoms scale to further explore the potential impact of treatment on vaginal dryness, painful intercourse, sexual interest and other quality-of-life domains. The open-access Clinical Breast Cancer paper can be accessed online here. To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit To learn more about the ELAINE studies, visit Goetz MP et al Annals of Oncology 2023;34:1141-1151 About LasofoxifeneLasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with a CDK4/6 inhibitor in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc., has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene's bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene's novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy, could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer. About SermonixSermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking a Phase 3 clinical study of lasofoxifene, its lead investigational drug. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. Elizabeth Attias, Sc.D., chief strategy and development officer, has extensive experience in pharmaceutical drug commercialization. Simon Jenkins, Ph.D., vice president of operations, has over 30 years of experience in global drug development leadership. Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Learn more at To learn more about the ELAINE studies, visit Sermonix Contact:Elizabeth Attias, Strategy and Development OfficerEAttias@ 723-7832Sign in to access your portfolio
