Cancer test for routine clinical testing
Radient Pharmaceuticals has received approval from the Korean FDA (KFDA) for Onko-Sure in-vitro diagnostic cancer test for routine clinical testing and government reimbursement throughout Korea.
The company has been selling its Onko-Sure IVD cancer test kits in Korea through an import certification to the esoteric market since 2003. KFDA approval allows Radient Pharmaceuticals to initiate a more robust commercialisation plan where RPC will provide Onko-Sure for both routine clinical and esoteric cancer testing in Korea.
The approval also enables Radient Pharmaceuticals to expand Onko-Sure product sales throughout Korea and ensures patients who are administered the Onko-Sure test will receive government reimbursement.
Douglas MacLellan, chairman and CEO of Radient Pharmaceuticals, said: “We are extremely pleased with the KFDA approval. This is a significant milestone that greatly advances product awareness, adoption and potential sales in Korea.
“This is a strategic market where cancer incidents are rising by 3.6 % annually and our Onko-Sure cancer test is in strong market demand. Our plan is to aggressively pursue this, and other, strategic markets where we have the potential of realizing strong product sales that enable us to reach profitability in the most efficient manner possible.”
Onko-Sure is a simple, non-invasive, patent-pending and regulatory-approved cancer test. For tested patients, Onko-Sure measures the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP) products.