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Rapid diagnosis of preeclampsia at the point-of-care

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Safer pregnancies thanks to quick, easy pre-eclampsia test

A rapid point-of-care diagnostic device allows doctors to check for the condition during routine check-ups, with no hospital visit necessary.

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Pre-eclampsia is a potentially life-threatening condition that can occur during pregnancy, jeopardising the health of both mother and child. The disease affects around 2-5 % of pregnancies in Europe, representing more than 200 000 women. Despite best efforts, it remains one of the leading causes of maternal mortality. Early diagnosis of pre-eclampsia is vital to minimise complications and prepare adequately for birth. The EU-funded PEDPOC project supported the Swiss firm MOMM Diagnostics in developing a commercial feasibility study for a novel test offering rapid early diagnosis and continual monitoring of pre-eclampsia. “There is a need for better diagnostics for pre-eclampsia – a majority of women are not tested properly,” notes Mathias Wipf, PEDPOC coordinator and CEO of MOMM Diagnostics. “We’re still reliant on blood pressure monitoring and proteinuria at the beginning of the second trimester.”

Saving time and lives

In recent years, he says, it has been shown that biomarkers in the mother’s blood give a better indication of whether she has the condition, or is at risk of developing it. The thumb-drive sized device built by MOMM Diagnostics uses a single drop of blood on a low-cost single-use cartridge to detect the presence of multiple biomarkers. The test takes less than 20 minutes, meaning it can be performed during routine medical check-ups. “Our tests help to rule out pre-eclampsia immediately, and so save lots of time,” explains Wipf. “Having the results available during the check-up means that the doctor can take an informed decision on-site, and doesn’t need to send patients to a hospital just because they show suspect symptoms for pre-eclampsia like elevated blood pressure.” The development comes at an opportune time: European nations are starting to implement routine pre-eclampsia tests, with Germany, Switzerland and the United Kingdom for example reimbursing them through general insurance. And for good reason: pre-eclampsia represents up to 30 % of the costs associated with obstetrics. “We think now is the best time, we don’t have to establish the market, but the market is not saturated either,” says Wipf.

Billion dollar market

The European market for pre-eclampsia diagnostics is projected to be worth EUR 1.1 billion by 2027. MOMM Diagnostics hopes to capture at least 5 % of that by 2028. Wipf adds that the PEDPOC devices represent an initial product in what is expected to be a rapidly growing market for accurate rapid diagnostics targeting low-abundance biomarkers. Right now, the devices are still in development, and have yet to undergo clinical validation and certification. Wipf says he expects to enter this stage in 2022 and bring the product to market the following year. Launching initially in Europe and the United States, the company will roll out to the wider world once a commercial partner is secured. PEDPOC further develops on the successes of previous EU-funded research, including the RECORD-IT project, part of the Future and Emerging Technologies programme. Wipf concludes that he is excited about the potential for the technology to help doctors and patients in the future, adding: “It’s fun to see how basic research evolves into a useful product.”

Keywords

PEDPOC, pre-eclampsia, pregnancy, point, care, rapid, test, diagnostic, low, abundance

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