ImCare Biotech, LLC news
A recent study has been published by investigators at the University of Turin in the peer-reviewed journal Current Oncology. This study focused on the performance of Seravue and the LC-SPIK biomarker in detecting hepatocellular carcinoma (HCC) in a pool of nonalcoholic fatty liver disease (NAFLD) related cirrhosis patients. Here, LC-SPIK had an AUC of 0.841 and significantly out
ImCare Biotech has been awarded a Phase IIB Bridge Award by the National Cancer Institute (NCI/NIH). This up to $4M over three-year award will be used to help ImCare Biotech pursue commercialization activities and support a pivotal clinical study for FDA clearance of Seravue®, a diagnostic testing product for Hepatocellular Carcinoma (HCC). This follows the promising results of a
The Centers for Medicaid and Medicare (CMS) announced the establishment of the MCIT (Medicare Coverage of Innovative Technology) pathway, which is designed to provide coverage and access to new, innovative medical devices and diagnostics which have received FDA Breakthrough Device Designation to Medicare beneficiaries nationwide. Through this pathway, Breakthrough devices will automatically be eligible for national Medicare coverage for a period of four years upon FDA clearance or appr
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
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