The University of California, San Francisco

FRIDAY, Jan. 17, 2025 -- Appropriate use criteria (AUC) for the use of amyloid and tau positron emission tomography (PET) have been issued by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging and published online Jan. 8 in both Alzheimer's & Dementia and the Journal of Nuclear Medicine . Gil D. Rabinovici, M.D., from the University of California San Francisco, and colleagues updated AUC for amyloid PET and developed AUC for tau PET. Key research questions that guided a systematic literature review on clinical amyloid/tau PET were identified. Based on this review, 17 clinical scenarios were developed in which amyloid or tau PET may be considered. The researchers found that seven scenarios were rated as appropriate, two as uncertain, and eight as rarely appropriate for amyloid PET. Five scenarios were rated as appropriate, six as uncertain, and six as rarely appropriate for tau PET. Both amyloid and tau PET are considered appropriate for patients presenting with mild cognitive impairment (MCI) or dementia who are younger than 65 years and in whom Alzheimer disease (AD) pathology is suspected; for patients presenting with MCI or dementia syndrome that could be consistent with AD pathology but has atypical features; to inform the prognosis of patients presenting with MCI due to clinically suspected AD pathology; and to determine eligibility for treatment with an approved amyloid-targeting therapy. "Amyloid and tau PET can support and enable earlier and more accurate diagnosis, which is essential to high quality care and treatment for dementia, providing appropriate support services and future planning," Rabinovici said in a statement. Several authors disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract/Full Text: Alzheimer's & Dementia Abstract/Full Text: Journal of Nuclear Medicine Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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

GE HealthCare and the University of California, San Francisco (UCSF) today announced the launch of a Care Innovation Hub. The joint research collaboration involving the UCSF Dept. of Radiology & Biomedical Imaging aims to address meaningful clinical challenges in accessibility to advanced medical imaging, noninvasive diagnosis and management of neurological and neurodegenerative disease and precision oncology. The hub is meant to leverage the strengths of academia and industry. It aims to create, evaluate and translate novel technology into a clinical setting. GE HealthCare and UCSF want to advance the diagnosis and treatment of disease. They hope to improve hospital operations and drive access to care. The company and university plan to develop more automated imaging methods, like patient-specific MRI techniques. Projects in this area focus on advancing quantitative imaging for cardiac and musculoskeletal disease. They want to develop methods to enable high-quality remote scanning. To expand the understanding of brain functions through advanced imaging, the teams aim to explore the links between white matter injury, vascular disease, and Alzheimer’s disease. They want to identify ways to predict treatment efficacy for brain health interventions. Finally, GE HealthCare and UCSF want to develop quantitative imaging methods to monitor patient response to radiopharmaceutical therapies. They aim to standardize processes for new approaches, like visualization of alpha-emitting radiopharmaceuticals. “We’re honored to collaborate with UCSF on this important work, which has the potential to significantly improve patient outcomes and address life-threatening diseases like Alzheimer’s disease and prostate cancer worldwide,” Erin Angel, GE HealthCare global VP of research and scientific affairs, said in a news release. “By combining our strengths, we’re taking steps toward solutions that meet real clinical needs. Together, we’re building something we hope will make a meaningful difference for patients and the future of healthcare.” GE HealthCare strikes another partnership In addition to the collaboration with UCSF, GE HealthCare entered into a seven-year strategic enterprise partnership with Sutter Health. This partnership, known as Care Alliance, aims to increase access to innovative imaging services. GE HealthCare wants to create a more seamless, coordinated experience for clinicians and patients across the Sutter Health system. The long-term collaboration seeks to increase access to essential diagnostic care across California. It marks one of GE HealthCare’s largest ever enterprise strategic partnerships. GE HealthCare said the first key focus area is an accelerated technology program focused on some of the most advanced AI-powered imaging technology and digital solutions available to patients. That includes PET/CT, SPECT/CT, MRI, CT, X-ray, nuclear medicine and ultrasound. “We are committed to support Sutter Health in its mission and have deep respect for their openness to a collaboration that meets the heart of their needs,” said Catherine Estrampes, U.S. and Canada president and CEO at GE HealthCare. “This Care Alliance is a customized, clinician-focused approach aligned with our shared goals. It was jointly designed with expert assessment of how we provide our latest imaging technology in the right settings to serve patients most efficiently throughout their care journey, closer to home. We look forward to supporting Sutter Health physicians and clinicians in delivering enhanced patients’ outcomes.”