Abbott prepares to launch ovarian cancer test
This article was originally published in The Gray Sheet
Executive Summary
Abbott plans a U.S. rollout of its Architect HE4 assay, the first automated diagnostic for monitoring the recurrence or progression of epithelial ovarian cancer, by the end of 2010, pending FDA approval of a December 2009 510(k) submission, firm says Feb. 8. The test, a two-step immunoassay for detection of HE4 antigen in human serum, uses chemilumuniscent technology to measure relative light units of the reaction to HE4 - shown in a 2003 study by Hellstrom, et al., to be the best biomarker for Stage 1 ovarian cancer. The test received European CE mark approval in January