Personalized diagnostics: the struggle for position

For several major cancers, drug selection already pivots on biomarker results (e.g., trastuzumab for breast cancer, and gefitinib and erlotinib for lung cancer). Fast-paced advances in genomic and proteomic laboratory technologies could enable the widespread use of molecular testing before therapy selection in any field of medicine. This article describes two potentially large obstructions to such innovation. First, laboratory tests have traditionally been commodities with low prices, prices that matched the resources required to operate the laboratory technology itself. Assuming that the marginal costs of molecular laboratory technology will fall, there will be a widening chasm between estimated test revenue and the costs of innovative and definitive clinical trials, and regulatory approval for new tests. Without corrective action, even cost-saving laboratory tests could be in shortfall, because they will not be created through upfront investment. Second, it is argued that while diagnostic tests, drugs and surgical procedures should meet a fundamental standard for payer coverage ('will health outcomes be improved?'), molecular diagnostics could require different analysis pathways than those that are used to evaluate interventions.