Diagnosing lung cancer – the need for a breath exam to follow a positive CT

Lung cancer is the leading cause of cancer deaths worldwide.  The 5-year mortality associated with lung cancer approaches 90%. This high mortality rate is partly related to late clinical diagnosis due to the lack of overt symptoms early in the disease progression. Low Dose CT is the most widely used diagnostic exam for lung cancer.  However, the median value of sensitivity, specificity, is only 81% and 81% respectively, 27% of CTs will be positive for at risk group and >90% of positive CTs turn out negative for lung cancer. The high false positive rate, creates harm, from biopsy (surgery harm and expense) and the obvious dangers and risks (continued tumor growth, radiation dose) that come from the “watch and wait” strategy that is part of the current guidelines: wait 6 months and do a repeat CT to re-assess.

There is therefore a pressing need for a complimentary lung cancer diagnostic to follow a CT which has detected a suspicious nodule. Metabolomx will offer a breath exam to follow a positive CT. The combination of a CT followed by a Metabolomx breath exam will lower the false positive rate by the accuracy of the breath exam. For example if the false positive rate for CT is 20% and the specificity of the breath exam is 90% the net false positive rate will only be 2%.

The National Cancer Institute recently announced results of their 53,000 patient National Lung Screening Study, which found that CT of high-risk patient populations extends life expectancy by approximately 20% (New England Journal of Medicine, June 2011).  The impact of this study has already been a powerful shift towards more widespread use of CT.

Most recently, the National Cancer Institute (NCI) awarded Metabolomx a $1,135,000 combined Phase I/II SBIR contract under its Fast Track program.