First POC ovarian cyst test receives regulatory approval
The device promises rapid discrimination between benign and malignant epithelial ovarian cysts within 15 minutes
2 Apr 2024
INEX Innovate has received regulatory approval from the Health Sciences Authority (HSA) in Singapore for its groundbreaking OvaCis® Rapid Test. As the company continues to advance women’s healthcare technology, this approval marks a significant milestone for OvaCis, an intraoperative in vitro diagnostic (IVD) medical device that can discriminate benign from malignant ovarian cysts. INEX OvaCis is also CE marked, and MHRA, UK registered.
OvaCis Rapid Test promises rapid discrimination between benign and malignant epithelial ovarian cysts within 15 minutes. As ovarian cysts affect as many as 1 in 10 women during their lifetime, OvaCis offers surgeons a vital tool to accurately assess cyst types intraoperatively, enabling timely decision-making and appropriate surgical interventions.
Ovarian cysts are a prevalent health concern for women worldwide. Surgical removal of ovarian cysts is part of the clinical management. During surgeries, quick discrimination between benign and malignant cysts is crucial for guiding surgical management and treatment decisions. OvaCis Rapid Test addresses this need by providing surgeons with real-time diagnostic information, facilitating more informed surgical approaches, and reducing the risk of unnecessary interventions.
With regulatory approval from the Health Sciences Authority (HSA) in Singapore, OvaCis Rapid Test is now positioned to revolutionize intraoperative diagnostics for women undergoing ovarian cyst surgery across Asia and beyond.