Radient Pharmaceuticals Corp., a US-based company focused on researching, developing, and commercializing In Vitro Diagnostic cancer tests, announced earlier today that it has received CE-Mark approval from the European Union (EU) for the use of its Onko-Sure® In Vitro diagnostic (IVD) cancer test as a pan tumor marker for cancer. The Company’s new CE-Mark Certificate for Onko-Sure® provides product access to 27 countries with a combined population of approximately 500 million.
A simple, non-invasive, patent-pending and regulatory-approved test, Onko-Sure® is used to detect, screen and monitor various types of cancer. The test enables physicians and healthcare professionals to effectively monitor and/or detect certain types of cancers by measuring the accumulation of Fibrin and Fibrinogen Degradation Products (FDP) in the blood. FDP levels rise dramatically with the progression of cancer. Onko-Sure™ is approved by the US FDA for the monitoring of colorectal cancer and by Health Canada as a lung cancer detection and monitoring test.
“The new CE Mark approval for Onko-Sure® in Europe is a significant accomplishment that validates the impressive results that have been observed with this test,” stated Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals. “RPC’s Onko-Sure® IVD cancer test has the potential to change the way cancer patients are diagnosed, monitored and treated.”
CE-Mark Certification clears the Onko-Sure cancer test kit for import and use in 27 countries including founding member states like the UK, Germany, and France, along with potential members like Turkey. According to the company, this new and product-specific CE-mark certification will also assist in their continuing efforts to expand the usage of Onko-Sure in key emerging markets like Asia, Latin America, Russia, and the Middle East.