Catherine D. O'Connell, Donald H. Atha, J P. Jakupciak
Over the past 10 years, DNA testing to identify disease associated mutations and specific organisms, which represent public health and safety concerns, have become major targets for laboratory testing. RNA testing is also emerging for gene expression, both for diagnostic applications and for the identification of new therapeutics. Gene expression technologies are potentially useful for commercial development of medical products that define promising therapeutics and clinical diagnostics. A critical issue for molecular diagnostics is reimbursement. When there is the convergence of strong demand coupled with clinical economics, important guidelines are needed to assure quality, safety and efficacy in order for tests to be reimbursed by insurance companies. Standards providing guidance and reference materials assuring quality data normalized across diagnostic platforms hold the promise to propel the conversion of molecular diagnostics from the bench-side to the bed-side by lowering costs and normalizing data across analytical platforms.