Novel blood test predicts preeclampsia months before onset

A new blood test, a liquid biopsy of maternal plasma cell-free RNA (cfRNA) developed by iPremom, can predict pre-eclampsia up to five months before symptom onset, according to a study.

The test, which can be performed once in the first trimester, ideally between nine and 14 weeks of pregnancy, can predict both early- and late-onset pre-eclampsia.

Pre-eclampsia is a high blood pressure condition that typically develops after 20 weeks into pregnancy. It can present serious risks to both mother and baby.

Screening for pre-eclampsia risk is essential, given that the disease can cause high blood pressure, organ damage, and even death of the mother and her unborn child. While there’s no guaranteed way to prevent pre-eclampsia, certain strategies can help lower the risk.

So, early and consistent prenatal care is essential for monitoring and managing potential risk factors.

According to the World Health Organisation (WHO), pre-eclampsia affects between two and eight per cent of pregnancies worldwide, causing around 46,000 pregnancy-related deaths and around 500,000 stillbirths or newborn deaths yearly.

The test, which demonstrated high accuracy in a prospective longitudinal study of over 9,500 pregnant women in Spain, offers a shift from reactive testing to preventive screening, providing a critical window for timely care.

It is recommended for all pregnant patients, regardless of their risk factors, as it detects biological risk independently of clinical history and can identify high-risk pregnancies that might otherwise go undetected.

The developers plan to seek regulatory approval in the United States, which will require a dedicated validation study in the United States’ population.

CfRNA analysis is considered a breakthrough in early screening for pre-eclampsia and a gateway to precision obstetrics, enabling proactive and tailored interventions.

The study received the “Clinical Science Award for Oral Presentation” and was published in Human Reproduction after the results were recently presented at the annual meeting of the European Society of Human Reproduction and Embryology.

Unlike current blood tests that focus on placental damage markers such as sFLT1 or PlGF — and are typically used once pre-eclampsia is suspected, this approach detects early genetic alterations in the mother, including the womb and placenta, well before symptoms emerge.

Tamara Garrido Gómez,  PHD, a senior principal investigator at the Carlos Simón Foundation and scientific director at iPremom, said the test is a different paradigm, unlike current blood tests that focus primarily on looking for markers suggestive of placental damage in women suspected to have preeclampsia.

According to him, “The use of the test as a universal screening tool, helping to identify high-risk pregnancies that might otherwise go undetected in traditional risk-based models.”

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