Differences in utilization of ALK rearrangement FISH analysis and EGFR assay.
e18067 Background: This study examined institutional and regional factors associated with use of ALK rearrangement FISH diagnostic test compared to the EGFR assay. Previous research presented at AACR Cancer Disparities conference illustrated substantial underutilization of the EGFR assay. Disparities existed in access by institutional and regional factors. Methods: We linked proprietary industry data for clinical diagnostic assays (EGFR mutation and ALK rearrangement) provided by Genzyme Genetics and Abbott Molecular to public datasets which provided institutional and regional characteristics of US hospitals. Individual orders were aggregated and summarized to the hospital. Each hospital’s Medicare provider number (known as the OSCAR number) was obtained and recorded. OSCAR number and zip code were used to link the proprietary and public datasets. Public datasets included Census files, CMS/NCI Provider of Service (POS) files, among others, all current as of 2011. Logistic and multiple regression analysis were conducted. Results: Initial analysis of data suggests higher utilization of the ALK rearrangement FISH analysis when compared to EGFR Assay. However, even with incorporation of both assays into clinical practice guidelines, significant institutional and regional differences existed in access to tumor tissue analysis. 7800 EGFR assay tests were sold in 2010. First 5 months post approval; approximately 12,000 Vysis tests were sold. A reasonable approximation of the testable population of NSCLC patients, given histology and tissue availability is approximately 114,000 patients. This suggests a 7% penetration rate for the EGFR mutation analysis and a 10% penetration rate for ALK rearrangement assay, though EGFR mutations have a 15% incidence rate compared to 5% incidence rate of EML-ALK4 rearrangement. Conclusions: Uptake of the ALK rearrangement assay is likely higher due to the linkage of crizotinib to the FISH diagnostic test. Utilization patterns show regional underutilization that could contribute to disparities.