TUSTIN, CA--(Marketwire - June 07, 2010) - Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today its partner Provista Life Sciences LLC (PLS), a diagnostics development and commercialization firm based in Phoenix, Arizona, is developing requisite clinical data through a validation study of DR-70 reagents for the introduction of RPC's Onko-Sure™ In Vitro Diagnostic (IVD) cancer test as a laboratory developed test for general cancer screening.
PLS has acquired more than 350 blood samples covering cancers ranging from breast to lung to uterine cancer for this landmark clinical study to demonstrate the diagnostic capabilities of the Onko-Sure test as a general cancer screening tool. The study is expected to be completed in June 2010.
According to William Gartner, President and CEO of Provista, "Provista is dedicated to developing new molecular diagnostics for early disease detection and we are extremely pleased to work with Radient on this particular study. Radient's Onko-Sure IVD cancer test is already US FDA-approved for colon-rectal cancer recurrence monitoring and has demonstrated high levels of accuracies in detecting other cancers as well. It is our hope that our study will also validate Onko-Sure as a general cancer screening tool."
Last month, Radient Pharmaceuticals signed a collaboration agreement with PLS whereby, PLS is providing CLIA (Clinical Laboratory Improvement Amendment) certified laboratory support services to RPC, including supporting on-going product development for Onko-Sure and securing insurance reimbursement and CPT code assignments for clinical laboratories using Onko-Sure in commercial laboratory efforts. PLS has also independently validated Onko-Sure as a potential screening tool for breast cancer detection.
Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals, stated, "Through internal testing we've demonstrated the ability of Onko-Sure to detect a wide range of cancers and are confident this validation study conducted by Provista Life Sciences will demonstrate the utility of our assay as a general cancer screening tool. Given this, RPC's commercialization opportunity of offering Onko-Sure as a low cost general cancer screen, both in the US and globally, is phenomenal."
Onko-Sure is a simple, non-invasive, patent-pending and regulatory-approved IVD test for use as an aid in early detection of cancer. Onko-Sure enables physicians and their patients to effectively monitor and/or detect certain types of cancers by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). FDP levels rise dramatically with the progression of cancer. Onko-Sure is approved by the US FDA for the monitoring of colorectal cancer, Health Canada as a lung cancer screen and cancer monitoring tool, and the European Union, Indian government, Korean government, and Taiwanese government as a cancer monitoring or cancer screening test. Onko-Sure test kits are currently sold as a blood test for cancer in Europe, India, Taiwan, Korea, Vietnam and in Chile for research use.
About Provista Life Sciences
Provista Life Sciences is a biotechnology diagnostics development and commercialization company located in Phoenix, AZ, that provides the scientific and operating management resources to rapidly advance the development and introduction of novel diagnostics technologies into the domestic and global marketplace. For more information, visit the company's Web site at www.ProvistaLS.com or call 1.602.224.5500.
About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is an integrated pharmaceutical company devoted to the research, development, manufacturing, and marketing of diagnostic and therapeutic products. Visit www.Radient-Pharma.com for additional information.
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