INEX Innovate receives EU CE-IVD Certification to detect cancer in ovarian cysts

12 May 2022 | Thursday | News

Asia's first molecular diagnostics company for women, INEX Innovate receives European CE-IVD Certification for its OvaCis(R) Rapid Test to detect cancer in ovarian cysts.
Image Source : Public Domain

Image Source : Public Domain

Revolutionary Ovarian Cancer Rapid Test Available Q4 2022

Known as a pioneer in Asia's women's and fetal health industry, Singapore-based diagnostics developer, INEX Innovate has obtained a CE mark for its lead ovarian cancer product, the OvaCis® Rapid Test. Slated to launch in the EU and Southeast Asian markets by the end of 2022, OvaCis® is a first of its kind point-of-care (POCT) test that discriminates benign from malignant ovarian cysts in an operating theatre setting.


A previous iteration of OvaCis® was launched in 2019, and the latest improvements now mean an extension of the product's shelf life to a minimum of 18 months at room temperature storage. This makes it convenient to store the kits in a primary healthcare setting.

Chief Executive of INEX Innovate, Kane Black remarked, "Ovarian cysts are a very common women's health condition. In fact, as many as 18% of women have them at some point in their lives[1] and about 8% of premenopausal women develop large cysts that need treatment[2]. With limited diagnostic options, this is an underserved population. This is mainly because the industry has been largely focused on upstream screening procedures such as early cancer detection."

The current standard of practice for ovarian cancer screening, called frozen section, increases the surgical procedure time by up to 60 minutes, consequently increasing the risk of infections and anaesthesia. Frozen section is also dependent on the skill of the pathologist conducting the biopsy sections, thus ovarian cancers (especially early ovarian cancers) can be missed.

OvaCis® Rapid Test works by identifying a protein biomarker (haptoglobin) evenly distributed in ovarian cysts fluid to determine if the cysts are benign or malignant. The test was developed as a rapid test format, and has proved to be user friendly requiring only minimal training and 5 minutes of hands-on time.

"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," added Black.


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