COTA Supports FDA Assessment of Real-World Data through Membership in COVID-19 Evidence Accelerator

COTA Genomic Profiling Study Released A retrospective review of the COTA Real World Data (RWD) database was performed to identify patients with pathologically confirmed metastatic colon cancer (mCC) diagnosed between January 1, 2013 and December 1, 2017. Although guidelines recommend molecular testing for patients with mCRC, the current study included patients with mCC and excluded rectal cancer cases. At the time of data extraction, the COTA database included demographic, diagnostic, treatment, and quality-of-care information for patients with colon cancer abstracted from the electronic health records from 23 practices including 258 oncologists in Arkansas, Maryland, Michigan, New Jersey, New York, and Tennessee who contribute data under Business Associate Agreements. All data were de-identified to be compliant with Health Insurance Portability and Accountability Act and Office of Health Promotion Research regulations for purposes of secondary research use. The structure of the COTA database has been reviewed by the Western Institutional Review Board and has been deemed exempt from patient informed consent. Read Full Release

COTA Signs Research Collaboration Agreement With The U.S. Food and Drug Administration COTA, Inc., a leading precision medicine technology company that uses real-world evidence to bring clarity to cancer care, today announced it has signed a two-year Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation (INFORMED) Program, the Agency's data science and technology incubator supporting regulatory science research. This RCA will establish a study protocol with an initial focus on breast cancer, and will provide the FDA with information on the evolving treatment landscape, including insight on treatment variation within defined subpopulations of patients with the disease. As the project advances, the research may expand to other cancer types and explore disease characteristics, treatment patterns, and patient outcomes for the broader application of precision medicine. Read Full Release

COTA Collaborates with Novartis Pharmaceuticals Corporation Cota Healthcare, the leading data and technology platform for value-based precision medicine, today announced the signing of a major, multi-year collaboration with Novartis Pharmaceuticals Corporation to help improve clinical and cost outcomes for breast cancer patients. As part of this agreement, which expands significantly on the previous announced collaboration entered into January 2016, teams from across Novartis Pharmaceuticals Corporation will leverage Cota's research-grade, real-world evidence, web-based analysis and visualization tools, and be supported by Cota's medical, data science, and technology experts. Utilizing the real-world evidence and technology platform supplied by Cota is expected to enable Novartis Pharmaceuticals Corporation to accelerate clinical development of new therapies for breast cancer and identify which patients will benefit most. Read Full Release