PHOENIX--(BUSINESS WIRE)--Global Cancer Diagnostics Inc. today announced the start of the final validation study of its new blood test for early detection of lung cancer. The study will complete the requisite analyses and data evaluation needed to validate the test and introduce it to the market. Global Cancer Diagnostics (GCDx) plans to offer this new test on a nationwide basis.
Clinical Studies to date demonstrated that The Lung Cancer Test for Early Detection™ successfully detected Stages 1 and 2 lung cancer with a high degree of accuracy in both men and women. The results generated in this final validation study are fully expected to be consistent with previous findings and produce positive clinical performance.
“By industry standards the studies have been very successful and will serve as the cornerstone to GCDx’s introduction of this new lung cancer detection assay to market,” shared Global Cancer CEO William Gartner. “GCDx intends to introduce The Lung Cancer Test for Early Detection™ out of its CLIA Laboratory immediately upon successful completion of this final study.” This validation study will allow the test to be marketed while the company seeks FDA clearance.
The Lung Cancer Test for Early Detection™ is intended for use in the high-risk lung cancer patient population which includes current and former smokers. While the Company intends to offer the test through standard clinical channels that include physicians, medical clinics and hospitals, a program has been developed to offer the test direct to consumers (DTC) through its website in the 26 states allowing DTC diagnostic sales. The company expects to seek FDA registration for The Lung Cancer Test for Early Detection™ in early 2015.
“We expect the test to be made available for a price that is easily within reach of the subject population, even those without medical insurance,” added Global Cancer Diagnostics’ VP of Marketing, Don Roberton.
“We believe this test will change the way that lung cancer is detected and can potentially save thousands of lives,” said Gartner.
About lung cancer
Lung cancer is the most fatal of cancers, taking an estimated 158,000 lives annually in the U.S. alone1. Lung cancer is the leading cause of cancer death among both men and women – only 16.6% of those diagnosed will live beyond 5 years. The 5-year survival rate rises to 53.3 when found contained to the lungs but only 15% of cases are diagnosed at an early stage. Smoking contributes from 80 to 90% of lung cancer deaths2. The CDC estimated in 2010 that there were 43.5 million smokers in the U.S. and that the number of former smokers "exceeded the number of current smokers"3.
About Global Cancer Diagnostics Inc.
Global Cancer Diagnostics is a privately owned biotechnology company with an in-house medical diagnostic laboratory. The Company is located in Tempe, AZ. The Company provides the scientific and operating management resources to rapidly advance the development and introduction of this novel diagnostic technology into the domestic and global marketplace. For more information, visit the company’s Web site at www.GlobalCancerDx.com.
1 American Lung Association. http://www.lung.org/lung-disease/lung-cancer/resources/facts-figures/lung-cancer-fact-sheet.html
2 Center for Disease Control and Prevention. http://www.cdc.gov/tobacco/data_statistics/sgr/2004/index.htm
3 Center for Disease Control and Prevention. http://www.cdc.gov/tobacco/quit_smoking/how_to_quit/you_can_quit/alone/