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.
Revolutionary Ovarian Cancer Rapid Test Available Q4 2022
SINGAPORE, May 11, 2022 /PRNewswire/ -- 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.
Citations:
[1] (Reference: Greenlee RT, Kessel B, Williams CR, et al. Prevalence, incidence, and natural history of simple ovarian cysts among women >55 years old in a large cancer screening trial. Am J Obstet Gynecol 2010; 202:373.e1-e9.) |
[2] (Reference: Ross, E.K. (2013). Incidental Ovarian Cysts: When to Reassure, When to Reassess, When to Refer. Cleveland Clinic Journal of Medicine; 80(8): 503–514. Retrieved from 2013 article.) |
About INEX Innovate
INEX Innovate is Asia's first molecular diagnostics company for women. To date, the group has launched 5 diagnostics tests, 7 different laboratory workflows, and developed a broad range of IP.
Emerging from the National University of Singapore (NUS), INEX is based in Singapore and was founded by veteran maternal fetal medicine specialists. Backed by institutional investors, it is uniquely positioned to identify and address clinically unmet needs within women's and fetal health landscape. The company focuses on developing and translating technologies that aim to deliver precision healthcare for women in Asia.
INEX Innovate develops diagnostics to support clinical decisions for various unmet women's health conditions, including in the oncology and reproductive health space. It has received significant interest from gynaecologists and onco-gynaecologists both in Singapore and the broader Southeast Asian markets, reinforcing the view that demand exists for unique solutions with clinical appeal and companies like INEX to step up to the challenge of catering to this emerging market.
Through their wholly owned subsidiary iGene Laboratory, INEX operates a state of the art Next Generation Sequencing Laboratory that provides diagnostic testing, clinical research (CRO) and COVID-19 testing services.
In 2021, INEX received the Frost & Sullivan 'Singapore Clinical Laboratories in Women's Health Entrepreneurial Company of the Year Award' and was also recognised by World Intellectual Property Organization (WIPO) and the Intellectual Property Office of Singapore (IPOS) with the 2021 IP for Innovation Champion Award. In 2022, the company was named one of Singapore's Fastest Growing Companies 2022 by The Straits Times and ranked as 7th Fastest Growing Health Care companies across Asia-Pacific by the Financial Times.
For more information visit: www.inex.sg
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