Radient Pharmaceuticals Corporation (RPC) has announced 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. RPC's new CE-Mark Certificate for Onko-Sure® is dated December 28, 2010 and provides product access to 27 countries with a combined population of approximately 500 million.
RPC's Onko-Sure™ IVC cancer test is a simple, non-invasive, patent-pending and regulatory-approved test used for the detection, screening, and monitoring of 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," said 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."
The EU does not have a Food and Drug Administration (FDA), thus, the task of regulating medical devices is handled by the European Commission in close cooperation with member state health authorities. Legislation adopted through this process covers in vitro diagnostic (IVD) tests like RPC's Onko-Sure that are "intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease." The legislation was amended (Directive 2007/47/EC) and became mandatory in 2010.
CE-Mark Certification specifically names our Onko-Sure cancer test kit and clears it for import and use in 27 countries including founding member states like the UK, Germany, and France, along with potential members like Turkey. Additionally, the CE-Mark Certification is a very important benchmark for product adoption in territories outside the EU.
This new and product-specific CE-mark certification will assist us in our continuing efforts to expand the usage of Onko-Sure in key emerging markets like Asia, Latin America, Russia, and the Middle East.