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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 […]
(45227)(0)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 […]
(54901)(0)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 […]
(64423)(0)ImCare Biotech recently published the results from its clinical study in the peer-reviewed journal Clinical and Translational Gastroenterology. The study, which was a prospective, double-blinded study, assessed Seravue’s ability to differentiate between patients with Hepatocellular Carcinoma (HCC), and benign liver conditions such as cirrhosis and chronic Hepatitis B and C. For any-stage HCC patients, Seravue demonstrated […]
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