A newly launched diagnostics evaluation service for companies could help standardize tests and ease their transition to market. The United States Diagnostic Standards (USDS), a nonprofit organization set up by the Critical Path Institute (C-Path), will provide independent test evaluations, effectively functioning as a voluntary “Underwriters Labs” for diagnostics companies, says Jeffrey Cossman, chief scientific officer at C-Path, of Rockville, Maryland. Analytic evaluations performed by the new entity will take place at carefully selected neutral sites. Under USDS policy, the clinical samples (e.g., blood, tumor tissue) used as standards in the evaluation of diagnostic assays must be approved by an independent, outside panel of experts. In some instances, well-established clinical samples may serve as standards so that assays from different suppliers can be compared. Although the group has no regulatory authority, diagnostic test manufacturers can use evaluation results to support an application for FDA approval. Alternatively, as one of its many services, the USDS will certify a Laboratory Developed Test (LDT) and ensure its performance. As Cossman explains, “The information [USDS provides] would be useful for [insurance] payers, clinical pathology laboratories, providers, as well as for regulators such as FDA, [and] might help with reimbursement decisions, as well as approval or assurance that an LDT (not evaluated by FDA) performs as labeled.”