Radient Pharmaceuticals Corporation engages in the research, development, manufacture, marketing, and sale of Onko-Sure test kit, which is a proprietary in-vitro diagnostic (IVD) cancer test. The company’s product is sold either directly to Clinical Laboratory Improvement Amendments (CLIA) certified reference laboratories or to third party distributors, who then resell to CLIA certified reference laboratories in the United States, as well as clinical reference labs, hospital laboratories and physician operated laboratories in the international market. Onko-Sure Onko-Sure is a non-invasive blood test designed to be used for the detection and/or monitoring of 19 different types of cancer, including lung, breast, tongue, stomach, liver, colon, rectal, bladder, brain, hematological, prostate, ovarian, esophageal, cervical, uterine, liver, trophoblastic, thyroid, malignant lymphoma, and pancreatic cancers. Onko-Sure is sold as a blood test for cancer in Europe (CE Mark certified), India, Japan, Taiwan, Korea, Vietnam, and in Chile (research use). In the United States, it is cleared by the Food and Drug Administration (FDA) for the monitoring of colorectal cancer treatment and recurrence, and is approved in Canada (by Health Canada) for lung cancer detection and treatment/recurrence monitoring. The company is involved with research conducted with CLIA laboratories to expand on the clinical utility of Onko-Sure. The Onko-Sure test kits are sold in the form of a 96 well test plate, which, after standards are applied, 41 individual tests can be run in duplicate. These tests are run in a reference laboratory with test results determined by using a micro-titer reading analyzer. The Onko-Sure IVD test enables physicians and their patients to detect and/or monitor the treatment/recurrence of solid tumors by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). Strategy The company’s objectives regarding the development, marketing and distribution of Onko-Sure test kit are to: obtain international approvals; develop new distribution channels in new market; distribute greater quantities of kits in approved markets; fully utilize GMP (Good Manufacturing Practices) manufacturing facilities in the U.S. to foster worldwide sales; automate the Onko-Sure test kit; and create a ‘rapid test’ format of Onko-Sure test kit to extend sales into rural areas and Physician Owned Labs (POL). Research and Development As of December 31, 2011, the company incurred an expenditure of $115,476 in research and development costs related to the clinical testing and study of Onko-Sure test kit. Collaborations In 2010, the company entered into an exclusive five-year collaboration agreement with Jaiva Technologies, Inc. (JTI). Patents The U.S. Patent and Trademark Office (USPTO) has issued two patents which describe methods for measuring ring-shaped particles in extra-cellular fluid as a means for detecting cancer. Its patent for a method of detecting the tumors using ring shaped particles as a tumor marker was issued on October 17, 1995 and expires on October 17, 2012. The company’s patent for a method for detecting the presence of ring shaped particles as tumor markers was issued on June 3, 1997 and expires on June 3, 2014. The company has three additional patent applications pending in the U.S. with respect to methodology for the Onko-Sure tumor-markers as indicators of the presence of cancer. In addition, the company has one patent based on methodology for the Onko-Sure tumor marker pending in Europe. Regulations The Onko-Sure test kit is subject to specific United States Food and Drug Administration rules applicable to IVD products. History Radient Pharmaceuticals Corporation was founded in 1988. The company was formerly known as AMDL, Inc. and changed its name to Radient Pharmaceuticals Corporation in 2009.