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 phase II clinical study, which demonstrated the high sensitivity and specificity of Seravue in its ability to detect liver cancer, especially in its early stages.
Seravue is an ELISA-based diagnostic test kit that is intended for use as an aid in the diagnosis of HCC (including early stages), 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 clinical information at an earlier stage while being minimally invasive. This could lead to improvements in patient outcomes for those at risk of developing liver cancer and lower treatment and management costs on the healthcare system.
Aaron Lu, Chief Executive Officer of ImCare Biotech says, “The generous support from the NCI and NIH has been invaluable to us so far. This award combined with the financial resources of our equity investors, will support our pivotal FDA study and facilitate regulatory approval.”
The Seravue is not yet approved in the U.S. or elsewhere. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
