A January 22, 2016 BioMed Central Pulmonary Medicine article details the trial design and establishment of a biospecimen repository necessary for the clinical validation of the AccuGenomics’ Lung Cancer Risk Test (LCRT). The LCRT is a 15-gene molecular test that could reduce overall lung cancer screening by demonstrating a person’s genetic propensity towards lung cancer, and indicate if they may avoid other repetitive, costly and inaccurate screening mechanisms. “If validated, the LCRT has the potential to significantly narrow the population of individuals requiring annual low-dose helical CT screening for early detection of lung cancer and delay the onset of screening for individuals with results indicating low lung cancer risk. For these individuals, the small risk incurred by undergoing once in a lifetime bronchoscopic sample collection for LCRT may be offset by a reduction in their CT-related risks,” says Dr. Willey the articles senior author. The test also would be utilized as a follow up diagnostic tool in undetermined bronchoscopies (i.e., failing to provide a conclusive diagnosis of cancer), which generally leads to surgical follow-up with twenty (20%) percent showing a benign outcome. AccuGenomics expects that the increasing prevalence of low dose CT screening will continue to drive additional follow up bronchoscopies, which in turn would dramatically increase the number of undetermined outcomes, potentially changing the screening paradigm for the more than 10 million at-risk persons in the United States alone, with commensurate, or event increased numbers in Europe and other large markets.
AccuGenomics believes that the entry of predicative tests like LCRT into the market will accurately identify individuals (approximately 60% of all smokers) that are actually at ‘low-risk’ of lung cancer due to genetics and could potentially avoid aggressive follow up treatments or even in some cases future routine screening. Eliminating 60% of the screening population would be expected to save more than $1 billion annually in the United States alone.