Global Cancer Diagnostics Inc (GCDx) has initiated the final validation study for 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. The company plans to offer the test on a nationwide basis.

The company’s previous clinical studies have demonstrated that its test successfully detected Stages 1 and 2 lung cancer with a high degree of accuracy in both men and women. The results generated in the final validation study are expected to be consistent with previous findings and produce positive clinical performance.


William J. Gartner

“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,” says William J. Gartner, GCDx CEO. “GCDx intends to introduce the Lung Cancer Test for Early Detection out of its CLIA laboratory immediately upon successful completion of this final study.” The validation study will enable the test to be marketed while the company seeks FDA clearance.

Located in Tempe, Ariz, GCDx is a privately owned biotechnology company with an in-house medical diagnostic laboratory. The company provides the scientific and operating management resources to rapidly advance the development and introduction of its novel diagnostic technology into the domestic and global marketplace.


Don Roberton

The GCDx test 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 the GCDx website in the 26 states allowing DTC diagnostic sales. The company anticipates seeking FDA registration for the test 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,” adds Don Roberton, GCDx vice president of marketing.

“We believe this test will change the way that lung cancer is detected, and can potentially save thousands of lives,” says Gartner.

For more information, visit Global Cancer Diagnostics Inc.