New Blood Test Simplifies PCOS Diagnosis

Image: The Elecsys AMH Plus has received a CE mark as a diagnostic blood test for PCOS (Photo courtesy of Roche)

Polycystic ovarian syndrome (PCOS), a common endocrine disorder affecting about 1 in 8 women of reproductive age, leads to anovulatory subfertility. Its diagnosis typically involves a combination of blood tests, including hormone profiling, ultrasound, and patient history. However, diagnosing PCOS, which encompasses a spectrum of physical and emotional health issues, has been challenging, with an estimated 70% of cases going undiagnosed. A few studies have suggested that an anti-Müllerian hormone (AMH) level exceeding 3.8–5 ng/mL could be indicative of PCOS. Now, an immunoassay, previously used in fertility diagnostics, presents a non-invasive alternative to traditional transvaginal ultrasound for PCOS diagnosis.

The Elecsys AMH Plus immunoassay from Roche Diagnostics (Basel, Switzerland) offers a less invasive, more comfortable, and possibly quicker method for diagnosing PCOS. This approach is particularly advantageous for those who are uncomfortable with transvaginal ultrasounds or are not sexually active. AMH, produced by granulosa cells in ovarian follicles, is found in higher quantities in patients with PCOS due to an increased number of follicles producing high levels of AMH. Studies have demonstrated that elevated AMH levels are a reliable diagnostic marker for PCOS. The Elecsys AMH Plus immunoassay aligns with the revised 2023 Rotterdam Criteria, which now recognizes that high AMH levels can indicate polycystic ovarian morphology (PCOM), a key marker of PCOS.

This development in both diagnostic criteria and technology marks a significant advancement in catering to the needs of women with PCOS. It offers an alternative to invasive transvaginal ultrasounds and could enhance early diagnosis rates. Roche has secured CE-mark regulatory approval for the Elecsys AMH Plus immunoassay, marking a pivotal moment in women’s healthcare, especially in addressing the widespread underdiagnosis of PCOS. Through this innovation, Roche aims to broaden access to PCOS diagnosis and promote early interventions to manage the condition, thereby mitigating risks of long-term complications such as type 2 diabetes.