BREA, Calif., April 10, 2018 /PRNewswire/ -- 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.
Beckman Coulter's broad portfolio of diagnostic instruments with
standardized test menus are designed for scalability from a small
physician office setting to an ultra-high volume laboratory. When
laboratories work with Beckman Coulter, there is a range of
solutions available for changing needs including instrumentation,
automation and clinical information management tools.
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.
Disclaimer: Not available in all markets. Check
with your local representative for availability.
© 2018 Beckman Coulter, the stylized logo and the Beckman
Coulter product and service marks mentioned herein are trademarks
or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
References:
- 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.
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SOURCE Beckman Coulter Diagnostics