Anti-Müllerian Hormone (AMH) assay.
In the rapidly evolving field of clinical diagnostics, collaboration often serves as the cornerstone of innovation. This was certainly the case for the development of an Anti-Müllerian Hormone (AMH) assay, a project that brought together the expertise Erasmus MC (Prof. A.P.N. Themmen and dr. J.A. Visser, department Internal Medicine) and Ansh Labs, US company to develop some of the most challenging hormone assays helping to advance clinical diagnostics in reproductive function.
The Challenge
AMH is a critical biomarker used in assessing ovarian reserve and fertility potential in women. Traditional AMH assays, while effective, faced limitations in terms of sensitivity, specificity, and consistency. Recognizing the need for a more reliable and accurate assay, the parties embarked on a collaborative journey to build an improved AMH assay and to discover (new) clinical applications and/or methods to measure AMH.
The Collaboration
Ansh Labs brought in its extensive experience in the development next generation of immunoassays for reproductive endocrinology research and diagnostics, while department of Internal Medicine of Erasmus MC contributed its knowledge concerning recombinant AMH (protein) production, AMH biological function and expertise in molecular biology.
The studies demonstrated that AMH is an excellent marker to determine ovarian responsiveness and measuring the levels of ovarian fertility reserve also in patients undergoing IVF. These findings served to develop several innovative products offered by Ansh Labs.
Ansh Labs has now two main assays for human AMH, the original Ultra-Sensitive (US) AMH ELISA and an assay designed with even more sensitivity for measuring the very low AMH levels in peri-menopausal women, the picoAMH ELISA.The picoAMH ELISA is versatile for assessment of menopausal status as well as research into areas such as oncofertility, primary ovarian insufficiency, and related fields.
This connection also served to spark other related areas of collaboration closer to the clinical implementation of the Erasmus MC’s technology licenses to Ansh Labs. The company has been involved also with the Department of Gynecology in a fruitful cooperation with Dr. Joop Laven in an study in which the licensed products contributed to evaluate Age-related Curves of AMH Using the Gen II, the picoAMH, and the Elecsys Assays in Women With Polycystic Ovary Syndrome. This study contributes to understand the AMH level in patients and its relevance in different stages of life.
The Impact
The successful development of the AMH assay helps to advance the field of reproductive medicine. Clinicians now have access to a more reliable tool for assessing ovarian reserve, leading to better-informed decisions in fertility treatments. Patients benefited from more accurate diagnoses and personalized treatment plans.
TTO was closely involved in licensing Erasmus MC’s technology to Ansh Labs. TTO facilitated the out licensing of research tools and know-how generated by Erasmus MC that helped advancing the product development. The collaboration between Ansh Labs and Erasmus MC resulted in superior sensitive and high precision diagnostic products that deliver/create direct benefits for the patients.
This success story highlights the importance of collaboration, innovation, and a shared vision in advancing medical science and improving patients outcomes.
