NEW YORK – Inex Innovate, a spinout of the National University of Singapore, announced on Wednesday that its ovarian cancer test has received CE marking.
The point-of-care OvaCis Rapid Test determines whether an ovarian cyst is benign or malignant by measuring haptoglobin, a protein biomarker that is evenly distributed in ovarian cyst fluid. It requires minimal training and five minutes of hands-on time and returns results in 15 minutes, the women's health company said in a statement.
"By providing results in 15 minutes, the surgical procedure time is significantly reduced, thus greatly reducing the risk of infection," Inex Chief Executive Kane Black said in a statement. "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 test is slated to launch in the EU and Southeast Asia by the end of 2022. A previous version of the test was launched in 2019, but the new version has extended the product's shelf life to at least 18 months when stored at room temperature.
In January 2020, Inex Innovate announced a distribution deal with Inalways to distribute the previous version of the test in Taiwan.