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The new Access Anti-Müllerian hormone (AMH) Advanced provides validated cut-offs for the assessment of ovarian reserve and ovarian response as an aid for women undergoing in vitro fertilisation (IVF).

Beckman Coulter, a global leader in diagnostics and infertility testing, announce the launch of an AMH test that uses a validated cut-off to aid in the assessment of poor ovarian response. This new assay helps clinicians predict poor ovarian response in those who plan to undergo controlled ovarian stimulation as part of an in vitro fertilisation (IVF) protocol[i]. The AMH Advanced assay is available in European countries that accept the CE marking.

An ongoing challenge for clinicians is the lack of a gold standard to assess ovarian reserve and ovarian response. There is no universally accepted clinical cut-off to define a normal versus an abnormal result for any available measure of ovarian reserve[ii]. Validated AMH cut-offs for ovarian reserve and ovarian response provide clinicians with the information they need to develop a personalised protocol to individualise treatment for controlled ovarian stimulation and improve the benefits and risks for the patient[iii].

“With the new Access AMH Advanced assay, clinicians now have a tool to predict poor ovarian response so they can establish individualised treatment for ovarian stimulation in women undergoing an assisted reproductive technology programme,” said Kathleen Orland, senior vice president & general manager of clinical chemistry immunoassay at Beckman Coulter Diagnostics.

According to the World Health Organization (WHO), infertility affects millions of people of reproductive age worldwide, adversely impacting families and communities. Estimates suggest that 48 million couples and 186 million individuals live with infertility globally[iv]. AMH is a widely accepted biomarker used to evaluate several clinical conditions, including infertility treatment, menopause evaluation, ovarian dysfunction (such as polycystic ovary syndrome), gonadotoxic cancer treatment and ovarian surgery.[v].

AMH testing has become increasingly important in monitoring female reproductive health to help provide personalised guidance, predict ovarian response to IVF treatment, and avoid ovarian hyperstimulation[vi]. The Advanced AMH assay provides accurate and validated assay-specific cut-offs to guide clinical use. The assay also aids in establishing the individual daily dose of the human recombinant follicle-stimulating hormone rFSH (follitropin delta) marked by Ferring Pharmaceuticals in controlled ovarian stimulation for the development of multiple follicles in women undergoing in vitro fertilisation.

“Beckman Coulter is the leading innovator in AMH testing, having pioneered the test over 20 years ago. Clinicians have continued to appreciate the utility of the test since, unlike other biomarkers, AMH has minimal variability throughout the menstrual cycle[vii],” said Heather Read-Harper, senior marketing manager for immunoassay and clinical chemistry at Beckman Coulter Diagnostics. “We continue on our innovator’s journey by delivering the only AMH assay on the market that provides its own validated cut-offs for ovarian response, while also assessing ovarian reserve.”

[i] ACCESS AMH ADVANCED, Instructions For Use, REF C62997, 2020, Beckman Coulter, Inc.
[ii] Ulrich, N. D., & Marsh, E. E. (2019). Ovarian Reserve Testing: A Review of the Options, Their Applications, and Their Limitations. Clinical obstetrics and gynecology, 62(2), 228–237. https://doi.org/10.1097/GRF.0000000000000445
[iii] Valerie L. Baker, M.D., Clarisa Gracia, M.D., Michael J. Glassner, M.D., Vicki L. Schnell, M.D., Kevin Doody, M.D., Charles C. Coddington, M.D., Sanghyuk S. Shin, Ph.D., Lorna A. Marshall, M.D., Michael M. Alper, M.D., Arlene J. Morales, M.D., Mary Ellen Pavone, M.D., Millie A. Behera, M.D., Edward A. Zbella, M.D., Bruce S. Shapiro, M.D., Ph.D., Joely A. Straseski, Ph.D., Dennis L. Broyles, M.S.H.S. (2018) Multicenter evaluation of the Access AMH antimüllerian hormone assay for the prediction of antral follicle count and poor ovarian response to controlled ovarian stimulation. (Fertil Steril 2018;110:506–13. 2018 by American Society for Reproductive Medicine.)
[iv] Infertility. (2020, September 14). World Health Organization. https://www.who.int/news-room/fact-sheets/detail/infertility
[v] Oh, S. R., Choe, S. Y., & Cho, Y. J. (2019). Clinical application of serum anti-Müllerian hormone in women. Clinical and experimental reproductive medicine, 46(2), 50–59. https://doi.org/10.5653/cerm.2019.46.2.50
[vi] Fiedler, K., & Ezcurra, D. (2012). Predicting and preventing ovarian hyperstimulation syndrome (OHSS): the need for individualized not standardized treatment. Reproductive Biology and Endocrinology: RB&E, 10(1), 32.
[vii] Gracia, C. R., Shin, S. S., Prewitt, M., Chamberlin, J. S., Lofaro, L. R., Jones, K. L., Clendenin, M., Manzanera, K. E., & Broyles, D. L. (2018). Multi-center clinical evaluation of the Access AMH assay to determine AMH levels in reproductive age women during normal menstrual cycles. Journal of assisted reproduction and genetics, 35(5), 777–783. https://doi.org/10.1007/s10815-018-1141-5

About Beckman Coulter

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhancing the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnerships. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, California, and has more than 11,000 global associates working diligently to make the world a healthier place.

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