Cangen Biotechnologies Inc. And Dai Nippon Printing Co., Ltd. Move Forward With Development Of An Early Stage Lung Cancer Diagnostic.Collaboration has resulted in successful first "proof of principal" phase BALTIMORE -- Cangen Biotechnologies, Inc. and Dai Nippon Printing Dai Nippon Printing (大日本印刷 Dai Nippon Insatsu Co., Ltd. (DNP DNP n. Deoxyribonucleoprotein; a complex of DNA and protein that usually yields DNA upon cell disruption and isolation. DNP 2,4-dinitrophenol. ) of Japan are pleased to announce that they will move forward with a clinical trial phase of an early stage lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. diagnostic. Based on successful first phase testing that utilized an assay technology combining proprietary technologies from each party, the assay was able to differentiate between normal and lung cancer samples. The 1000 patient sample study was performed in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. at a publicly held third party CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a certified laboratory. "Cangen is extremely pleased with the results thus far of this collaboration," said Chul So Moon, M.D., Ph.D., Chief Executive Officer and Chief Science Officer of Cangen Biotechnologies. "Together with our partners at DNP, we are poised to introduce the first blood test diagnostic for early stage lung cancer." Cangen and DNP will begin the clinical trial phase in early 2009 with FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. submission of the test expected by 2011. "As we move forward with this new biotechnology, we are excited about the prospect of being able to offer earlier lung cancer detection with greater accuracy," said Cathy McDermott, RN, MPH, Vice President, Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: To accelerate the project, Cangen will receive a milestone payment as part of the Technical Collaboration Agreement with DNP initiated in March 2007, for its technical contribution to the collaboration. Further development of the product may lead to additional milestone payments to Cangen toward the funding of a Phase 3 trial in the United States. According to the Centers for Disease Control (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ), more people die annually from lung cancer than any other type of cancer. The National Cancer Institute estimates over 215,000 new cases and over 160,000 deaths from lung cancer (non-small cell and small cell combined) in the United States in 2008. Cangen Biotechnologies, Inc. is a cancer-focused biotechnology company developing diagnostic tests for early detection of cancer. The company is currently preparing to file a 510 (k) submission to the FDA for a molecular diagnostic test for the detection of bladder cancer bladder cancer Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor. recurrence. Cangen Biotechnologies is headquartered in Baltimore, MD, has laboratories in Rockville, MD and plans to open a research center at the Hopkins BioPark in Baltimore, MD. The company has offices in Korea and Japan. Dai Nippon Printing Co., Ltd. is one of the world's largest comprehensive printing companies and conducts a wide range of businesses, including publication printing, commercial printing, smart cards, business forms, packaging, decorative materials, networking and electronic components. DNP has over 38,000 employees and its net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight in fiscal year ending March 31, 2008, were over 1.616 trillion yen. For more information on DNP, please visit www.dnp.co.jp. This press release contains forward-looking statements and estimates with respect to the anticipated future performance of Cangen Biotechnologies Inc and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company's control, and may turn out to be materially different. |
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