Breast Carcinoma in Situ

LAGUNA HILLS, Calif., Jan. 16, 2025 /PRNewswire/ -- Prelude Corporation (PreludeDx®), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT® test. DCISionRT provides individualized risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer. DCISionRT represents a significant advancement in DCIS patient care by combining tumor biology with clinicopathologic factors to deliver personalized results. The test analyzes seven protein biomarkers and four clinical factors to generate a Decision Score that helps physicians identify which patients are most likely to benefit from RT and can help reduce over- and under-treatment. "DCISionRT addresses an unmet need for DCIS patients by answering the questions, 'Do I need radiation therapy?', and 'will I benefit?'. DCISionRT helps patients and their physicians to make a better and more informed treatment decision." says Dan Forche, President and CEO of PreludeDx. The test is designed for women aged 30-85 with DCIS and: Predicts the benefit of radiation therapy after breast conserving surgery (BCS) Is Prognostic for 10-year risk of breast cancer recurrence Identifies patients with residual risk even after BCS and radiation therapy The FDA's Breakthrough Device designation is reserved for medical devices that provide for more effective treatment or diagnosis, and offer significant advantages over existing approved or cleared alternatives. Breakthrough Devices will receive priority review by the FDA, which can significantly shorten the time it takes to get approval. Forche continued, "We will continue to work closely with the FDA and we remain committed to providing access to advanced precision diagnostics in breast cancer care that improve patient outcomes through new and innovative tools." 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. The test provides a DecisionScore™ that identifies a woman's risk as low, elevated, or residual risk. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, and uses 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™. 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ClearCoast™ is the only Portable MRI system that provides real time intraoperative objective, quantitative, and immediately actionable information on margin malignancy assessment during Breast Conserving Surgery REHOVOT, Israel, Jan. 8, 2025 /PRNewswire/ -- ClearCut Medical, a commercial stage privately held company, developed the ClearCoast™, the first and only portable MRI system that performs real-time intraoperative margin assessment of excised breast tumors during Breast Conserving Surgery (BCS). Clear margins are critical in order to minimize the risk of recurrence and the need for retreatment. Continue Reading ClearCoast™ portable MRI system that provides the surgeon real time information on margin assessment during Breast Conserving Surgery, developed by ClearCut Medical Ltd. The study aimed primarily to compare retreatment proportion within and between study groups with accordance to the SSO-ASTRO guideline. The secondary endpoint compared ClearCoast™ and the Standard of Care (SoC) diagnostic ability to detect positive margins intraoperatively, as well as the total excised breast tissue volume between study groups. "ClearCoast™ is the most promising technique currently available for intraoperative margin assessment in breast conserving surgery of in situ and invasive breast cancer" said Prof. Dr. Marc Thill, director of the Department of Gynecology and Gynecological Oncology at the Agaplesion Markus Hospital in Frankfurt, Germany and PI of the study. "Following previous trials and after using the technique in our interventional post-marketing ClearCoast™ study, I am convinced that the technique is ready for clinical routine." ClearCoast™ demonstrated a sensitivity of 81% and a specificity of 70%. It detected 92% of the DCIS compared to 18% in the control group. Moreover, the surgeon removed less breast tissue (69.9cm3 vs. 153.2 cm3) without increasing the duration of the procedure. Lastly, ClearCoast™ showed a potential for an 80% reduction in re-excisions. "These results emphasize its potential in reducing the burden of re-excision for patients and the Healthcare costs without trading off time for precision", said Hezi Himelfarb, CEO of ClearCut Medical. "The intuitive display of the system produces images that can be immediately interpreted by the surgeon, without the need for other specialists." The system received CE Mark approval and is being sold in Europe by pfm medical gmbh. About Clear-Cut Medical Clear-Cut Medical is dedicated to improve the quality of care for cancer patients using MRI, the trusted gold-standard imaging modality for cancer diagnostics. The company developed the ClearCoast™, a powerful 1.2T MRI system used to assess the margin of the lumpectomy specimen that is encased in a proprietary disposable chamber inserted into the system. It is fully shielded with no special facility requirements or interference with other instruments in the OR, and provides real-time quantitative information in an intuitive topographic display that is interpreted by the surgeon with no need for additional experts. The surgeon can instantly identify marginal areas suspected to be malignant and proceed to remove immediately additional tissue before sending the specimen to pathology and by this, reduce significantly the re-excision rate. The system utilizes state-of-the-art proprietary MRI technology for real time tissue margin assessment. Clinical trial results in BCS have shown high sensitivity and specificity and a potential reduction in re-excision of up to 80%. Contact: Hezi Himelfarb [email protected] Photo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MONDAY, Jan. 6, 2025 -- The incidence of in situ breast cancer has decreased since 2009, consistent with decreasing use of mammography in association with the 2009 U.S. Preventive Services Task Force (USPSTF) guideline change, according to a study published online Dec. 27 in JAMA Network Open . Carina Zhang-Petersen, M.D., from the University of Vermont in Burlington, and colleagues examined the incidence of breast cancer by stage at diagnosis and surgical treatment before and after the 2009 guideline change in an epidemiologic cohort study of women aged 40 years or older using 2004 to 2019 data. Data were included for 2,022,250 women (17.5, 63.2, and 19.2 percent aged 40 to 49, 50 to 74, and 75 years and older, respectively) diagnosed with breast cancer. The researchers found that since 2009, there was a decrease in rates of in situ breast cancer (e.g., annual percent change [APC], −0.69 for women aged 50 to 74 years). During 2004 to 2019, localized breast cancer rates increased steadily among women aged 40 to 74 years (e.g., APC, 1.18 for women aged 50 to 74 years); during the study period, there was no evidence for a change in trend. Since 2012, distant cancer rates were flat among women aged 40 to 74 years and increased steadily for those aged 75 years and older during 2004 to 2019. "The incidence of in situ breast cancer decreased with the decrease in use of screening mammography dating back to the 2009 USPSTF guideline change," the authors write. "However, to date, there does not appear to be evidence that reductions in screening and in situ breast cancer diagnoses have translated to increases in the incidence of more advanced stage breast cancer." Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.