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Abbott Submits Architect HE4 Assay For FDA Clearance

Abbott Diagnostics has submitted its diagnostic assay, Architect HE4, for FDA 510(k) approval. Architect HE4 assay uses a simple blood test to help monitor the recurrence or progression of epithelial ovarian cancer.

The company has partnered with Fujirebio Diagnostics in the development of the assay. The Architect HE4 assay has been approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the US.

The new assay is designed to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data. Certain types of cancer like mucinous or germ cell tumors rarely express HE4, and the use of Architect HE4 assay is not recommended for monitoring patients with those types of cancer, said the company.

Reportedly, the 2003 Hellstrom et al. study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker and is considered as a single marker for stage 1 of the disease.

Michael Warmuth, senior vice president of Abbott Diagnostics, said: “The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The Architect HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease.”