Shuwen Biotech Announces NMPA Approval of Rapid, Non-Invasive Preeclampsia Detection Kit for Diagnosis of Preeclampsia
DEQING, ZHEJIANG, CHINA, October 16, 2020 /EINPresswire.com/ — Shuwen Biotech, a China-based integrated in vitro diagnostics company, today 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.
"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," said Jay Z. Zhang, Chairman and CEO of Shuwen Biotech.
About Shuwen Biotech
Shuwen Biotech is a China-based diagnostic company founded on the principles of innovation, patent protection, and international collaboration as its strategic platforms for growth. Since 2011, Shuwen established strategic partnerships with numerous outstanding academic and commercial institutions to commercialize first-in-class diagnostic technologies and patents and has developed a range of novel diagnostics in the fields of cancer, women's health, and health screening among others. Shuwen has also developed quality companion diagnostics and provided central lab biomarker testing services to leading pharmaceutical developers. Shuwen houses an in -house development team, CAP-accredited central labs, and ISO13485-certified IVD manufacturing facilities, all in line with global standards to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health.
Vafa Amirkia, Ph.D.
Source: EIN Presswire