Pennsylvania June 8th, 2020: The FDA has granted Breakthrough Device Designation for Seravue® to support earlier diagnosis of Liver Cancer using a simple blood test. Seravue® is intended for use as an aid in the diagnosis of Hepatocellular Carcinoma (HCC), including early stage HCC, in patients with an elevated risk of developing HCC, in conjunction with ultrasound imaging or alone in cases where ultrasound is deemed inappropriate. Seravue®, which utilizes the novel IM-08 biomarker, has potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to the healthcare system. The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide ImCare Biotech with priority review and interactive communication regarding device and data development, through to commercialization decisions. ImCare Biotech are very pleased with the FDA designation and looks forward to continued communication with the FDA in order to support commercialization efforts.
