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Health Canada Licenses Beckman Reproductive Health Assay

NEW YORK (360Dx) – Beckman Coulter Diagnostics said on Wednesday that Health Canada has licensed its Access Sensitive Estradiol assay, giving Canadian labs access to an accurate and sensitive diagnostic test that aids in patient reproductive health management. The firm said that the assay — which detects levels of estradiol, a natural hormone, in women, children, and men — helps labs deliver more accurate results for patients.

The assay surpasses clinical decision limits for in vitro fertilization hyper-responders, which could enable labs to avoid costly dilutions, Beckman said. Citing a study in the Taiwanese Journal of Obstetrics & Gynecology, the firm said that more than 27 percent of samples from patients undergoing in vitro fertilization may require dilution and subsequent reruns.

"The new Access Sensitive Estradiol assay offers improved measurement of low levels of estradiol, such as those typically found in men, pediatric populations, and postmenopausal women," Michael Samoszuk, chief medical officer of Beckman Coulter Diagnostics, said in a statement.

The assay complements its automated Anti-Müllerian Hormone assay for fertility testing, Beckman said. The assays expand the company's reproductive health portfolio, giving clinicians a menu of reproductive endocrinology and prenatal screening assays, the firm said.

It also noted that its Access assays use the same reagent packs, which are standardized for use on all Beckman Coulter immunoassay systems and help to drive operational efficiency for clinical labs.