World’s First Intraoperative Point-of-Care Device for Ovarian Cyst Operation Receives Regulatory Approval from Health Sciences Authority (HSA) of Singapore

2024-03-27

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Singapore, 27 March, 2024 - INEX Innovate is excited to share that its groundbreaking product, OvaCis® Rapid Test, has received regulatory approval from the Health Sciences Authority (HSA) in Singapore. 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 to discriminate benign from malignant ovarian cysts. INEX OvaCis® is also CE marked, and MHRA, UK registered. OvaCis® Rapid Test is a globally patented Point-Of-Care device designed specifically for intraoperative use, providing rapid discrimination between benign and malignant epithelial ovarian cysts within just 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. "Receiving regulatory approval from the Health Sciences Authority (HSA) in Singapore for OvaCis® is a momentous achievement and a testament to our commitment to advancing women's health," said Dr. Sidney Yee, Executive Director of INEX Innovate. "With OvaCis®, we empower surgeons with a reliable intraoperative diagnostic tool to accurately discriminate between benign and malignant ovarian cysts, and improve patient care and surgical outcomes." 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. INEX Innovate remains dedicated to advancing innovations in molecular diagnostics to improve outcomes for women's health conditions. For more information about OvaCis® and INEX Innovate, please visit About INEX Innovate: INEX Innovate is Asia's first healthcare technology company for women, founded as a spin-out from the National University of Singapore (NUS). Focusing on innovations in molecular diagnostics, the company is dedicated to addressing unmet needs in women's and antenatal health. INEX Innovate aims to make its technologies accessible to women around the world, providing greater certainty and confidence in diagnostic testing. Media Contact: marketing@inex.sg

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