Molecular Diagnostic Test for Lung Cancer Is Highly Accurate

A study found that a molecular diagnostic test for lung cancer demonstrated high levels of accuracy.

A standardized reverse transcription polymerase chain reaction (StaRT-PCR) platform technology was used for measuring messenger RNA (mRNA) transcripts levels of 15 genes that could serve to predict lung cancer. The test for these genes, in normal cells sampled via bronchoscopy, identified those individuals genetically at risk for lung cancer. In a study of 49 subjects, the test was able to correctly identify the individuals with cancer 96% of the time.

James C. Willey, M.D., founder and chief science and medical consultant to the company Gene Express (Toledo, OH, USA), and colleagues from the University of Toledo (OH, USA) measured transcript abundance (TA) of 15 genes that encode protective antioxidant and DNA repair proteins in lung airway cells taken from 25 people with lung cancer and 24 people without the disease. Their previous research allowed them to determine the threshold levels of TA for each gene--the point at which the amount of mRNA transcripts would indicate a tendency toward cancer. In this study, they used the threshold levels as a basis to assign a value of one or zero to each of the targeted genes for an individual subject, with "zero” indicating normal TA.

If the sum total of a subject's target genes was greater than or equal to seven, the genes could collectively serve as a biomarker for lung cancer. The results yielded one false negative and seven false positives among the 49 individuals assessed. According to Dr. Willey, a positive result in a subject without lung cancer may not actually be a false positive, but rather could mean that the person is at an increased risk for lung cancer, which might arise later.

"Overall, the study showed a high degree of accuracy for picking out lung cancer patients,” said Dr. Willey. CEO of Gene Express, Gerald Vardzel added, "We are excited about these results, as they demonstrate the value of our platform technology in the development of molecular diagnostics and the movement towards personalized medicine.”

The study was presented at the American Association for Cancer Research's second International Conference on Molecular Diagnostics in Cancer Therapeutic Development in September 2007, which was held in Atlanta, GA (USA).


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University of Toledo