Abbott Receives FDA Clearance for 2G Testosterone Immunoassay

FDA has cleared an upgraded test from Abbott Laboratories for diagnosing a range of testosterone-related disorders affecting men and women, the company announced. The Architect 2nd Generation Testosterone Assay is a chemiluminescent microparticle immunoassay designed to help treat problems such as hypogonadism and delayed puberty in men and infertility and excess body hair in women. Frank Quinn, Abbott’s director of global scientific affairs for endocrinology, says the second-generation test “is more sensitive, accurate, and precise than previous versions of the assay.”
Abbott points to published studies showing that many available testosterone tests lack the sensitivity to measure low levels of the androgen hormone, limiting the clinical usefulness of the tests. “The improved assay performance means physicians will be able to obtain more reliable measurements of testosterone and use this information to help guide patient treatment decisions,” Quinn says.
The new assay, which runs on Abbott’s automated analyzer platform, is available in the United States, Japan, and several countries in Europe Latin America, Africa, and the Middle East. Approval for sale in India is pending.

---John Conroy