Molecular Diagnostics Program in Lung Cancer

Early Detection of Lung Cancer is a Critical Unmet Clinical Need

Early diagnosis of lung cancer for patients at high risk is a clear unmet medical need. The American Cancer Society projects in 2008 a total of 215,020 people were diagnosed and 161,840 people died from lung cancer. Approximately 84% of newly diagnosed lung cancer patients have cancer progression beyond the local site either to lymph nodes or as a distant metastasis leading to five year expected survival rates of only approximately 15.1%.

Source MDx has established extensive programs in the development of lung cancer diagnostics including biomarkers of lung cancer and related conditions. Using its patented Precision Profile™ technology, the company identified prospective biomarkers associated with the characterization and evaluation of lung cancer in an exploratory clinical trial in 2006 and 2007. Results from this initial clinical trial led to the November 2007 patent filing - the basis for the Precision Profiles for Early Detection of Lung Cancer.

Source MDx's patented diagnostic tests are based on RNA transcript-based gene expression measurements in whole blood using quantitative PCR, optimized for clinical use in a commercial setting. Precision Profiles for Early Detection of Lung Cancer have the potential to provide non-surgical detection of lung cancer for high risk smokers and patients with pulmonary disease. An early detection blood test can improve patient outcome and greatly reduce the need for and costs associated with unnecessary surgeries and expensive imaging.

Key Clinical Collaboration with New York University School of Medicine

Through collaboration with New York University (NYU) School of Medicine, the Precision Profile for Early Detection of Lung Cancer is being developed as part of an ongoing National Cancer Institute Early Detection Research Network study. The Source MDx/NYU School of Medicine Clinical Team is led by:

• Dr. Harvey Pass, Professor and Division Chief of Thoracic Surgery, Dept. of Cardiothoracic Surgery
• Dr. William Rom, Director, Division of Pulmonary and Critical Care Medicine

Next Steps for the Source MDx/NYU School of Medicine Collaboration

This ongoing study involves the collection of blood samples from 900 patients, including 300 patients with suspected lung cancer undergoing resection and 600 case controls comprised of smokers, pulmonary disease patients and healthy subjects. This trial is expected to conclude in early 2010, and will be followed by a prospective multi-site clinical study designed for regulatory approval. The National Cancer Institute Early Detection Research Network academic medical centers and the Dana-Farber/Harvard Cancer Center sites are anticipated to participate in this pivotal trial.