Natera, San Carlos, Calif, has received the CE mark for the Signatera test, a personalized, tumor-informed ctDNA assay optimized for molecular residual disease (MRD) assessment and treatment monitoring in patients previously diagnosed with cancer. With the CE mark, Natera can now make Signatera available to clinics and hospital systems throughout Europe to support patient management and clinical research. “Signatera represents a significant leap forward in how we treat cancer patients in the adjuvant, neoadjuvant, and metastatic settings,” says Andrés Cervantes, MD, PhD, professor of medicine and head of the department of Medical Oncology at the University Hospital, University of Valencia, Spain. “We look forward to incorporating this technology into MRD-guided clinical trials and into clinical practice across a variety of solid tumor types.” Europe has approximately one-quarter of all cancer cases diagnosed globally, with some 3.7 million new patients per year, according to data from the World Health Organization (WHO) Regional Office for Europe.1 “Obtaining the CE mark for Signatera is an important step in making personalized ctDNA testing available globally, for both research and clinical use,” says Solomon Moshkevich, general manager of oncology at Natera. “To our knowledge, this is the first bespoke assay to ever receive the CE mark, a testament to the strength of our scientific and regulatory teams, and a milestone in our journey to making Signatera a standard of care for cancer management worldwide.” For more information, visit Natera. Reference
- Data and statistics. World Health Organization Regional Office for Europe. https://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/data-and-statistics.
Imaging of metastatic cancer cells spreading on the surrounding tissue. Image © Nicola Ferrari Dreamstime ( ID 45971826).