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Abbott CE marks HE4 ovarian cancer test

This article was originally published in Clinica

Executive Summary

Abbott has CE marked its Architect HE4 ovarian cancer diagnostic for sale in Europe. The blood test helps to determine, in combination with the established ovarian cancer diagnostic CA125, whether a pelvic mass is benign or malignant. Abbott claims it is the first automated HE4 test available anywhere in the world. The five-year survival rate for ovarian cancer is currently low (around 46%) due to late diagnosis, but if it is diagnosed early, this increases to over 90%. Outcomes are also improved if patients are operated on by a specialist surgeon, but as most masses turn out to be benign, this is often not the case. Abbott, which co-developed the test with Fujirebio Diagnostics, recently submitted a 510(k) application to the US FDA.

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