NEW YORK — Shuwen Biotech said Tuesday that it has received approval from China's National Medical Products Association for a point-of-care preeclampsia test.
CercaTest Red is designed to detect misfolded proteins associated with the hypertensive condition in urine samples. It can be used both at home and at medical facilities and provides results within five minutes, according to the Deqing, China-based company.
"CercaTest Red may support effective detection and screening of preeclampsia outside of the traditional clinic setting and in between appointments," Shuwen Biotech Executive Chairman and CEO Jay Zhang said in a statement. "As onset and aggravation of preeclampsia may be sudden and unpredictable, continuous and remote testing could save lives especially in those at high risk or with suspected preeclampsia."
Shuwen Biotech said marketing of the test outside of China would be handled by its German subsidiary, Cerca Biotech.