Singapore-based molecular diagnostics company Inex Innovate has received CE-IVD certification for its OvaCis Rapid Test for detecting cancer in ovarian cysts.
The ovarian cancer product is planned to be launched in the European Union and Southeast Asia markets by the end of the year.
A first of its kind point-of-care test (POCT), OvaCis distinguishes benign from malignant ovarian cysts in an operating theatre setting.
The user-friendly rapid test can decide if the cysts are benign or malignant by detecting a protein biomarker called haptoglobin, which is found in ovarian cysts fluid.
Furthermore, OvaCis needs only minimal training and five minutes of hands-on time to offer results in 15 minutes.
A prior version of OvaCis was unveiled in 2019, and the new improvements have extended the test’s shelf life to at least 18 months when stored at room temperature.
This allows the kits to be easily stored in a primary healthcare setting.
Inex Innovate chief executive Kane Black said: “OvaCis empowers surgeons to make fast, informed, evidence-based decisions within the confines of a high-pressure surgical environment.
“By providing results in 15 minutes, the surgical procedure time is significantly reduced, thus greatly reducing the risk of infection.
“It also adds a layer of assurance for clinicians to make decisions about the extent of the surgery and the final reproductive status of a patient.”
The existing standard of practice to screen for ovarian cancer is a frozen section, which lengthens the time of the surgical procedure by up to 60 minutes.
It also raises the risks of infections and anaesthesia.
Furthermore, as the frozen section is dependent on a pathologist’s ability to perform biopsy sections, ovarian cancers, particularly the early ones, can be missed.