LungCentury Gx Summary
Gene Express has developed LungCentury Gx, a gene expression quantification test that is designed to help healthcare professionals identify individuals with the highest risk of developing lung cancer. The intended population for LungCentury Gx is adults 50 years of age or older who have smoked at least a pack a day for 20 years and have no evidence of lung cancer. This test will provide physicians a means to identify which smokers or ex-smokers will develop the disease. LungCentury Gx can guide the use of diagnostic tests such as chest helical computed tomography (hCT) and Positron Emission Tomograpghy (PET) scans to detect lung cancer at very early stages when it’s most treatable.
It is known that approximately 10% of the 40 million smokers in the US will develop lung cancer. Until now, physicians had no means to identify which smokers or ex-smokers who will develop the disease. Currently it is estimated that over 160,000 persons die of lung cancer in the United States each year. Approximately 90% of these cases are current or former smokers. LungCentury Gx is a new and important tool to reduce the mortality of this tragic disease.
StaRT-PCR™ LungCentury Gx test:
Measures the expression of ten genes including genes responsible for activities such as DNA repair and detoxification of free radicals.
Requires normal bronchial epithelial cells (NBEC) obtained by cytology brush through a bronchoscope
Test Description:
The StaRT-PCR™ LungCentury Gx test measures the 10-gene panel in normal bronchial epithelial cells (NBEC) obtained by cytology brush through a bronchoscope. For this test, total RNA from NBEC is reverse transcribed to cDNA with oligo dT primers and this cDNA is quantitatively calibrated such that the amount of ACTB in the cDNA sample is equal to the amount of ACTB internal standard in the SMIS™. All subsequent high-throughput StaRT-PCR reactions contain the calibrated cDNA, SMIS and primers specific for the 10 gene panel, ACTB or an endogenous control gene. Data are analyzed as an odds ratio and reported as the number of transcription molecules per 106 endogenous control gene. Each gene is then compared to a cut-point threshold value and assigned a cancer-risk or no cancer-risk assignment. The individual scores are then mathematically assembled to determine a final risk assignment.