Shuwen Biotech Announces NMPA Approval of Rapid, Non-Invasive Preeclampsia Detection Kit for Diagnosis of Preeclampsia

Shuwen Biotech announced that the China National Medical Products Administration (NMPA) has approved its patent-protected Preeclampsia Detection Kit, a rapid non-invasive urine-based point-of-care test for the detection of preeclampsia.

Preeclampsia occurs in 10 million pregnant women worldwide every year and is the second leading cause of death of pregnant women and fetuses. The condition also results in more than 2.5 million preterm births every year.  In addition, preeclampsia is often associated with serious complications and morbidities in pregnant women. Thus there is an urgent need for an accurate and cost effective tool for early screening and diagnosis of preeclampsia.

Shuwen’s Preeclampsia Detection Kit has previously been CE-marked and also registered in India and other countries with high birth rates. Shuwen has partnered with PerkinElmer outside of China to promote and distribute the kit.

Jay Z. Zhang, Chairman and CEO of Shuwen Biotech Said: “The NMPA approval is another major milestone for clinical management of preeclampsia in China.  We look forward to the commercial launch in China so that our innovative product can help obstetricians and pregnant women to improve the quality of pregnancy and save lives in this time of unprecedented uncertainty.”

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