Medical Device Network

Metabolon scores NIH award to develop PCOS diagnostics

Metabolon plans to use the funds to identify biomarkers of PCOS and modernise the classification of the disease subtypes.

The US National Institute of Health (NIH) has awarded US-based Metabolon a grant to develop more accurate diagnostics for polycystic ovary syndrome (PCOS).

PCOS is a chronic condition that can cause hormonal imbalances, irregular periods, infertility, excess androgen levels and cysts in the ovaries. There is no treatment for the disease, but the symptoms can be improved through lifestyle modification, medications, and fertility treatments. As per the World Health Organization (WHO), approximately 8%–13% of women of reproductive age have PCOS, and up to 70% of these cases are undiagnosed.

PCOS is currently through a combination of blood tests, including hormone profile, ultrasound, and patient history. Often the diagnosis is made by the exclusion of other conditions. Metabolon plans to identify metabolite biomarkers of PCOS which can then be used to better classify the patients for targeted treatment.

"[Currently] PCOS is diagnosed using the Rotterdam criteria, which were developed decades ago based on expert opinion rather than on objective criteria. This diagnostic algorithm likely misclassifies or outright misses a lot of cases," said Adam Kennedy, associate director of research and development at Metabolon.

Rotterdam criteria defines PCOS as the presence of two of the three criteria - oligo‐anovulation (irregular ovulation), hyperandrogenism (excessive testosterone) and polycystic ovaries (≥ 12 follicles measuring 2mm‐9mm in diameter and/or an ovarian volume > 10mL in at least one ovary). There is a growing body of research noting that Rotterdam criteria are quite broad and can lead to potential misdiagnosis. Therefore, specific phenotyping of PCOS is needed to ensure an appropriate diagnosis.

There has been a growing interest and investment in women’s health. The North American women’s health market is forecast to be worth $170.4m in 2025, as per GlobalData analysis.

Metabolon’s PCOS project will be conducted over the next 12 months. The company also plans to apply for additional grants to build on the current PCOS project.

In October, Metabolon launched liver fibrosis and kidney function discovery panels to analyse metabolites that affect these conditions. The data could then be used to research disease mechanisms and enable research.