Zhejiang-based ShuWen Biotech Co., Ltd has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative CercaTest Red, a patented self-test designed for household use by pregnant women to screen for preeclampsia. This marks the first time a self-test of this kind has been approved for home use outside of medical institutions globally.
Preeclampsia, often referred to as “pregnancy toxicity,” is a pregnancy-specific condition that can lead to elevated blood pressure, proteinuria, and potential organ dysfunction after the 20th week of gestation. Characterized by its complex and variable symptoms, preeclampsia poses a significant risk to both maternal and fetal health. It is one of the most common pregnancy complications, with an incidence rate ranging from 2% to 8% among pregnant women worldwide. The condition and its severe form, eclampsia, result in nearly 80,000 maternal and 500,000 fetal deaths annually, making it the second leading cause of maternal mortality.
Given the diverse and intricate clinical presentations of preeclampsia, along with the varied initial symptoms and unpredictable progression, regular prenatal hospital visits often struggle to detect the condition promptly. The availability of a self-test like CercaTest Red has the potential to significantly improve early detection rates and management of preeclampsia.- Flcube.com
