Medical Device News Magazine

Tuesday, March 21, 2023

Shuwen Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its Breakthrough Preeclampsia Detection Device in Unselected Women

Shuwen Biotech Co. Ltd., a China-based leader in innovative diagnostics announced today the peer-reviewed publication of data highlighting the potential of its breakthrough point-of-care test in rapidly diagnosing Preeclampsia among women who are admitted to the hospital. The paper, entitled “Late pregnancy screening for preeclampsia with a urinary point-of-care test for misfolded proteins”, was written by collaborators from China Medical University’s Shengjing Hospital and Columbia University Medical Center in New York and demonstrates the ability of the test to detect preeclampsia at a high level of accuracy in women admitted to the hospital for any reason. The findings included over 1,500 women and were published in the peer-reviewed journal PLOS One.

According to the WHO, almost 80,000 women die and half a million pregnancies are lost each year from preeclampsia and related hypertensive disorders. Preeclampsia affects 2–8% of pregnancies worldwide and in places such as Latin America, it represents the number one cause of maternal death. Unfortunately, in the majority of cases, symptoms of preeclampsia are not noticeable until it has progressed, emphasizing the major unmet need for an objective and effective test, particularly in low- and middle-income countries. The kit is a highly attractive tool for healthcare professionals, patients, and governments globally to rapidly, cost-effectively, non-invasively and accurately diagnose a condition which otherwise often is misdiagnosed and requires lengthy hospitalizations and monitoring for patients.

In the study, researchers collected urine from 1,532 pregnant women hospitalized at 20-41 weeks gestation, regardless of the reason for hospitalization, and prospectively tested misfolded proteins in pregnant women’s urine using Shuwen’s patented point-of-care test device. Results showed a very high screening performance in a first-to-be studied Chinese population.

Shuwen’s Chairman and CEO, Jay Z. Zhang, M.S., J.D said, “We at Shuwen are grateful to our collaborators for their hard and diligent work over the last few years to demonstrate how our Company principles of innovation, patent protection, and international collaboration can lead to tangible and outstanding clinical value for patients and other stakeholders. The data published in this paper reinforce the clinical importance of point-of-care testing in preeclampsia globally. We look forward to continuing to build this important clinical body of evidence.”

The test kit is already CE marked by Shuwen and available for sales and clinical use in an increasing number of countries as regulatory processes progress across the world.

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