FDA clears Abbott's ovarian cancer monitoring test
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Abbott's Architect HE4 ovarian cancer blood test. It is designed to monitor patients for recurrence or progression of the disease – 75% of patients experience recurrence, according to the company. However, it is not recommended for screening or in women with mucinous or germ cell tumours, which rarely express HE4. Abbott (Abbott Park, Illinois) hopes its HE4 test, in combination with the current gold-standard ovarian cancer biomarker, CA125, could improve patient monitoring. CA125 is widely used for this purpose, but 20% of ovarian cancers do not express the biomarker, the firm claims. Abbott CE marked the Architect HE4 for sale in Europe earlier this year (www.clinica.co.uk, 15 January 2010).