Health Canada Licenses Beckman Coulter’s Access Sensitive Estradiol Assay

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

BREA, Calif. — (June 20, 2018) — Beckman Coulter Diagnostics announced today its Sensitive Estradiol Assay is now licensed by Health Canada, giving laboratories and clinicians in country access to the accurate and sensitive diagnostic test that aids in patient reproductive health management. The Access Sensitive Estradiol assay is commonly used to detect estradiol levels in women, children and men, and features low-end precision and state-of-the-art sensitivity to 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 in vitro fertilization (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 IVF hyper-responders. This may allow laboratories to report accurate patient results, while avoiding the costly dilutions. Access Sensitive Estradiol is the only assay in the market with published pediatric reference ranges. Its unique combination of high sensitivity and broadest measuring range aims to provide better operational efficiency, reduce costs 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 postmenopausal 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 complements Beckman Coulter’s already-available automated Anti- Müllerian Hormone (AMH) assay for fertility testing. Together, these assays expand the company’s reproductive health portfolio, giving clinicians a comprehensive menu of reproductive endocrinology and prenatal screening assays. The Beckman Coulter family of Access assays use the same common reagent packs, which are standardized for use on all Beckman Coulter immunoassay systems—including the Access 2, UniCel DxI 600 Access and UniCel DxI 800 Access systems—helping to drive operational efficiency for clinical laboratories.

Beckman Coulter’s broad portfolio of diagnostic systems with standardized test menus are designed for scalability, providing high performance and quality results for laboratories of all sizes, from small practice physician offices to ultra-high-volume clinical diagnostic laboratories. When laboratories partner with Beckman Coulter, there is a range of solutions available for their changing needs, including instrumentation, automation systems and clinical information management tools.

1. Wu, CH; Kuo, TC; Wu, HH; Yeh, GP; Tsai, HD. “High serum estradiol levels are not detrimental to in vitro fertilization outcome.” Taiwan J Obstet Gynecol, 2007 March, 46(1) 54–9.

About Beckman Coulter
Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. For over 80 years, Beckman Coulter has been the partner of choice for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.

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