Gene Express Inc, Toledo, Ohio, says its molecular diagnostic test for lung cancer has demonstrated high levels of accuracy in a recent study presented at the American Association for Cancer Research‘s second International Conference on Molecular Diagnostics in Cancer Therapeutic Development.

James C Willey, MD, founder, inventor, and chief science and medical consultant to the company, and his colleagues from the University of Toledo, identified a panel of 15 genes that could serve to predict cancer. 
A test for the genes, in normal cells sampled via bronchoscopy, could serve as a technique to identify individuals genetically at risk for lung cancer, according to Willey.

In a study of 49 subjects, Willey and his colleagues were able to identify the individuals with cancer 96% of the time. To determine which genes are active in lung cancer, the researchers used Gene Express’s proprietary and patented StaRT-PCR(standardized reverse transcription polymerase chain reaction) platform technology for measuring messenger RNA (mRNA) transcripts levels of the 15 genes.

The researchers had previously published findings demonstrating that genes responsible for protecting lung cells from damage caused by cigarette smoke or environmental toxins are suboptimally regulated in the normal lung cells of individuals who develop lung cancer. In the study, they put their theories to the clinical test by measuring 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 the 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 researchers found.  The results yielded one false negative and seven false positives among the 49 individuals assessed. They believe a positive result in a subject without lung cancer may not actually be false positive, but could mean the person is at an increased risk for lung cancer, which might arise later.

Gene Express furthers drug and molecular diagnostic development by providing standardized genomic data. The company’s proprietary and patented StaRT-PCR platform technology for measuring gene expression levels in cells, clinical biopsies, and blood is being used by several pharmaceutical concerns and academic centers.