Abbott receives US regulatory approval for Architect AFP

Abbott has been granted US regulatory approval for its CE-Marked Architect AFP test, which is used to detect the presence of two important health issues.

The US Food and Drug Administration (FDA) has ratified the assay for use in the diagnosis of foetal birth defects and the progression of testicular cancer through the detection of biomarkers.

Substances in the body such as alpha-fetoprotein can be measured to identify the progress of diseases or conditions as well as to evaluate the effectiveness of treatments, making this a potentially important new product launch.

The assay runs on Abbott's fully-automated Architect i2000, i2000SR, ci8200 and ci16200 analysers.

Brian Blaser, executive vice-president for diagnostics products at Abbott, said: "The Architect AFP assay is a valuable tool that will help physicians obtain reliable measurements of this protein for use in guiding critical patient treatment decisions."

This comes after an FDA advisory committee recently voted favourably on the benefits of the company's MitraClip device for patients with significant symptomatic mitral regurgitation.