FDA approvals

FDA clears new testosterone test

Today, Abbott announced FDA clearance for a new testosterone test, the Architect 2nd Generation Testosterone Assay.

The new assay is a chemiluminescent microparticle immunoassay for the quantitative determination of testosterone in human serum and plasma.

The test will help diagnose and treat disorders like primary and secondary hypogonadism, delayed or precocious puberty and impotence in men, as well as hirsutism, virilization due to tumors, polycystic ovaries and androgenital syndromes in women.

The assay, which is more sensitive, accurate and precise than previous versions of the assay, is available in the US, as well as several European countries, Asia Pacific, Latin America, Japan, Africa, the Middle East and India, pending country registration, according to a press release.