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US FDA clears Abbott’s new testosterone test

Abbott has received US Food and Drug Administration clearance for its new testosterone test, ARCHITECT 2nd generation testosterone assay.

The testosterone assay is expected to help physicians to accurately measure the wide range of testosterone levels seen in men and women, according to the company.

Abbott endocrinology global scientific affairs director Frank Quinn said,"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."

The new assay made of Abbott’s ARCHITECT family of analyzers, is available in the US as well as in several European countries, Asia Pacific, Latin America, Japan, Africa, the Middle East, and India, pending country registration.

The assay is a chemiluminescent microparticle immunoassay to determine testosterone quantity in human serum and plasma.