What You Should Know:– A collaborative effort between COTA, PreciseDx, and Baptist Health South Florida seeks to revolutionize breast cancer recurrence risk assessment with the PreciseBreast™ (PDxBr) test. This AI-powered tool holds promise for faster, more accurate, and more affordable risk prediction compared to current methods.– By utilizing AI technology, PreciseBreast™ has the potential to offer patients a faster, more accurate, and more affordable way to assess their risk of recurrence and make informed treatment decisions in collaboration with their physicians.The Challenge of Breast Cancer RecurrenceOne in eight women in the US will face a breast cancer diagnosis in their lifetime. Understanding a patient’s specific risk of recurrence is crucial for informing treatment decisions. While existing gene-expression tests offer some insights, they have limitations:Limited Accuracy: Current testing methods may not capture the full picture of recurrence risk.Current testing methods may not capture the full picture of recurrence risk. High Cost: Gene-expression tests can be expensive, potentially limiting access for some patients.Gene-expression tests can be expensive, potentially limiting access for some patients. Delayed Results: Waiting two to four weeks for test results can delay critical treatment decisions.PreciseDx Aims to Transform Risk AssessmentPreciseDx’s PreciseBreast™ test utilizes artificial intelligence (AI) to analyze pathology slide images

NEW YORK--(BUSINESS WIRE)--Today, COTA announced an extension of its research collaboration with ​​the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence. Under the collaboration, the two organizations will continue to jointly develop and implement research projects to advance the use of real-world data (RWD) and explore the potential strengths and limitations of using real-world evidence (RWE) for regulatory purposes. This collaboration serves as an extension of the agreement between COTA and the FDA established in 2018. To date, the partnership has yielded numerous oncology research studies that have been presented at the annual meetings of the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR). The collaboration has been extended for an additional 5 years, focusing on leveraging real-world evidence to strengthen regulatory decision-making

What You Should Know:– COTA, a leader in real-world data and analytics solutions, today announced a five-year extension of its research collaboration with the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE).– The five-year extension builds upon a successful partnership established in 2018 and signifies a continued commitment to utilizing real-world data (RWD) to enhance cancer treatment and regulatory decisions.Building on a Successful FoundationThe initial collaboration, established in 2018, has yielded significant results. Joint research efforts have produced numerous oncology studies presented at prestigious conferences like the American Society of Hematology (ASH) and the American Association of Cancer Research (AACR).Leveraging RWD for Stronger Regulatory DecisionsThe extended collaboration focuses on harnessing the power of RWD to strengthen the FDA’s regulatory decision-making process. Key areas of focus include:RWD Study Design and Analysis: COTA and the FDA will collaborate on developing optimal RWD study designs and analytical methods for investigating clinically relevant questions.COTA and the FDA will collaborate on developing optimal RWD study designs and analytical methods for investigating clinically relevant questions. Priority Research Questions: Joint efforts will prioritize research questions that address critical aspects of cancer care, treatment, and patient outcomes.Joint efforts will prioritize research questions that address critical aspects of cancer care, treatment, and patient outcomes. New Data Sources: The collaboration will explore the utilization of new oncology data sources to support the OCE Scientific Collaborative’s mission.The collaboration will explore the utilization of new oncology data sources to support the OCE Scientific Collaborative’s mission