Beckman Coulter Diagnostics Announces Worldwide Commercialization of the Access Sensitive Estradiol

The new Access Sensitive Estradiol assay rounds out the comprehensive reproductive menu for the Access immunoassay systems and provides better operational efficiency while delivering quality results

BREA, Calif. — (April 10, 2018) — Beckman Coulter Diagnostics today announced commercialization of its Access Sensitive Estradiol in the U.S., with simultaneous commercial availability of its assay in the majority of global markets. The test is commonly ordered for detecting estradiol levels in women, children and men. With low-end precision and state-of-the-art sensitivity, the Access Sensitive Estradiol assay will help laboratories deliver more accurate results for patients seeking answers to reproductive health questions.

According to a recent publication by Wu et al. more than 27% of samples from patients undergoing IVF may require dilution and subsequent reruns.1 The Access Sensitive Estradiol assay has the broadest measuring range on the market, surpassing clinical decision limits for in-vitro fertilization (IVF) hyper-responders. This may allow laboratories to report accurate patient results, while avoiding these costly dilutions. Access Sensitive Estradiol is the only assay in the market with published pediatric reference ranges. The assay's unique combination of high sensitivity and broadest measuring range aims to provide better operational efficiency, reduce cost and deliver quality results to make a difference in patients' reproductive health.

"The new Access Sensitive Estradiol assay offers improved measurement of low levels of estradiol, such as those typically found in men, pediatric populations and post-menopausal women. There is emerging evidence that estradiol levels play an important role in maintaining men's reproductive health. Hence, this new assay will enable accurate testing for estradiol in all patient populations," said Michael Samoszuk, M.D., chief medical officer, Beckman Coulter Diagnostics.

The launch of Access Sensitive Estradiol follows the recent FDA clearance of Beckman Coulter's automated Anti-Müllerian Hormone (AMH) assay in the United States. Together, these assays expand the company's reproductive health portfolio, making it a comprehensive menu of reproductive endocrinology and prenatal screening assays. The reproductive portfolio is available for use in common reagent packs and with standardized results on the entire Beckman Coulter family of immunoassay systems -including the Access 2, DxI 600 and DxI 800- designed to drive operational efficiency for clinical laboratories.