Noninfiltrating Intraductal Carcinoma

LAGUNA HILLS, Calif., March 14, 2024 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in precision diagnostics, has unveiled data from an analysis of over 700 early-stage invasive breast cancer patients for AidaBreast™ - a novel biosignature that predicts 10-year recurrence rate and radiation therapy (RT) benefit - at the 41st Annual Miami Breast Cancer Conference (MBCC). Building on the clinical adoption of the company's initial test offering, DCISionRT®, which predicts radiation benefit for patients with ductal carcinoma in situ (DCIS), AidaBreast™ will provide personalized testing to the larger Stage I and IIA breast cancer market. AidaBreast™ is powered by a multi-omic platform utilizing proteomic and genomic analyses, and offers a unique, differentiated approach to determine individual patient risk profiles. The first test in the AidaBreast™ portfolio will be for the assessment of radiation therapy benefit. "We are very encouraged by the predictive data presented at the Miami Breast Cancer Conference. We look forward to the launch of AidaBreast™ to initially assist with radiation treatment decisions, and soon after to help answer additional therapeutic questions, so that we can significantly increase our clinical impact in the broader breast cancer market," said Dan Forche, President and CEO of PreludeDx. "Our focus remains on delivering precision diagnostics to enhance shared decision-making between physicians and their patients." The poster entitled, 'A Novel Biosignature for Early-Stage Invasive Breast Cancer to Predict Radiotherapy Benefit and Assess Recurrence Risk for Patients Treated with Breast-Conserving Surgery', demonstrates the potential of the assay to predict radiation benefit in over 700 patients diagnosed with hormone receptor-positive, HER2-negative, Stage I, IIA, node negative, no evidence of metastasis breast cancer who underwent breast conserving surgery (BCS) with or without RT. The biosignature identified clinically meaningful risk groups with differential RT benefit associated with 10-year recurrence rate. The identified low-risk group had a recurrence rate of 1% with or without RT. The elevated risk group had a recurrence rate of 20% without RT and 13% with RT. The residual risk group had a recurrence rate of 30% with or without RT. "While tests for predicting the benefit of chemotherapy and endocrine therapy currently exist for early-stage breast cancer patients, AidaBreast™ addresses the gap for assessing radiation therapy benefit," said Chirag Shah, MD, radiation oncologist at Cleveland Clinic, co-director of the comprehensive breast cancer program, and director of breast radiation oncology. "The test fills a long-needed void in providing better tools which can optimize shared treatment decision-making based on each patient's unique biology." PreludeDx Additional Poster Presentations at MBCC 2024: A Comparative Analysis of Changes in Treatment Recommendation for Black and White Patients with Ductal Carcinoma in Situ Using a 7-Gene Predictive Biosignature: Analysis of the PREDICT Study Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women with Low-Risk DCIS after Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-year Ipsilateral Breast Recurrence (IBR) Rates About DCISionRT for Breast DCIS DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman's individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score™ that identifies a woman's risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT's intelligent reporting provides a woman's recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions. About PreludeDx PreludeDx is a leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient's treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™. PreludeDx is a Fjord Ventures portfolio company. For more information on how PreludeDx is making a difference for patients, please visit the Company's website: and follow us on Twitter @PreludeDx, Facebook, Instagram and LinkedIn. PreludeDx, the PreludeDx logo, DCISionRT, the DCISionRT logo, DecisionTree, Decision Score, The DCIS Test, Know Your Risk and Your Biology, Your Decision are trademarks of Prelude Corporation or its wholly owned subsidiaries in the United States and foreign countries. SOURCE PreludeDx

THURSDAY, Jan. 25, 2024 -- Women with non-screen-detected ductal carcinoma in situ have an increased risk for invasive breast cancer and breast cancer death, according to a study published online Jan. 24 in The BMJ . Gurdeep S. Mannu, M.B.B.S., D.Phil., from the University of Oxford in the United Kingdom, and colleagues examined the long-term risks for invasive cancer and death related to breast cancer after non-screen-detected ductal carcinoma in situ among 27,543 women in England who were diagnosed during 1990 to 2018, outside the National Health Service breast screening program. The researchers found that by Dec. 31, 2018, 3,651 women with non-screen-detected ductal carcinoma in situ had developed invasive breast cancer (ratio of observed to expected rate, 4.21). Throughout follow-up, the ratio of observed to expected rate of developing invasive breast cancer remained elevated among women aged younger than 45 to 70 years. The 25-year cumulative risks for invasive breast cancer were 27.3, 25.2, 21.7, and 20.8 percent for those with a diagnosis of ductal carcinoma in situ at age younger than 45, 45 to 49, 50 to 59, and 60 to 70 years, respectively. Overall, 908 women died of breast cancer (ratio of observed to expected rate, 3.83); the ratio remained elevated throughout follow-up. The 25-year cumulative risks for breast cancer death were 7.6, 5.8, 5.9, and 6.2 percent, respectively, by age at diagnosis. "These findings should inform considerations regarding the frequency and duration of surveillance following a diagnosis of ductal carcinoma in situ, particularly for women diagnosed at younger ages," the authors write. Abstract/Full Text Editorial Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

FRIDAY, Jan. 12, 2024 -- For patients undergoing surveillance following diagnosis and treatment of ductal carcinoma in situ (DCIS), very few second breast cancers are detected by clinical breast examination by a physician, according to a study published online Dec. 28 in the Journal of the National Comprehensive Cancer Network . Bethany T. Waites, M.D., from the Kaiser Permanente San Francisco Medical Center, and colleagues performed a retrospective cohort study of patients with DCIS treated between Jan. 1, 2008, and Dec. 31, 2011, to assess the modes of detection of second cancers. The study cohort included 1,550 women (median age at diagnosis, 59 years), who were followed for a median of 10 years. During follow-up, 179 women (11.5 percent) were diagnosed with a second breast cancer: 43.0, 54.8, and 2.2 percent were ipsilateral, contralateral, and presented with distant metastases, respectively. Of the second cancers, 61.5, 36.3, and 2.2 percent were invasive, DCIS, and Paget disease, respectively. The researchers found that second breast cancers were imaging-detected, patient-detected, physician-detected, and detected incidentally on imaging or pathology from procedures unrelated to oncologic care in 74.3, 20.1, 2.2, and 3.4 percent of cases, respectively. "Our findings highlight the importance of mammogram screening and patient education regarding self-detection, and can inform future National Comprehensive Cancer Network recommendations for DCIS survivorship care," the authors write. Abstract/Full Text Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.