Axis-Shield receives FDA approval for testosterone assay
Dundee, Scotland-based company Axis-Shield (A-S) has received approval from the FDA to market a test to detect the hormone testosterone in body fluids in the US, using Abbott's widely placed AxSYM laboratory analyser.
Dundee, Scotland-based company Axis-Shield (A-S) has received approval from the FDA to market a test to detect the hormone testosterone in body fluids in the US, using Abbott's widely placed AxSYM laboratory analyser.
A-S manufactures the test in its Dundee facility and it was launched in non-US markets earlier this year. Testosterone monitoring is used clinically to aid in the diagnosis of many diseases including infertility, pituitary disease, adrenal disease, obesity, polycystic ovary syndrome and male impotency. The Abbott AxSYM System is used in thousands of hospital and clinical laboratories worldwide and is the leading high throughput immunoassay platform.
Svein Lien, Axis-Shield chief executive officer commented: 'We are pleased to be able to announce FDA marketing approval of this important test on the highly successful AxSYM system and its imminent launch into the large US market. We look forward to further menu extensions for this platform next year under our agreement with Abbott signed in 2003.'