Collaborative Framework Proposed to Streamline LDT Validation Across US Hospital Labs

Original abstract

Laboratory-developed tests (LDTs) play a critical role in meeting unmet diagnostic needs, particularly for rare infections and high-acuity or immunocompromised patient populations. However, current US regulatory and reimbursement frameworks have constrained innovation and delayed implementation of many essential laboratory diagnostic tests. Here, we propose a pragmatic, collaborative model focusing on infectious disease molecular diagnostics that maintains analytical rigor while allowing clinical validity to be supported by evidence from the medical literature and clinical judgment. To address the resource constraints faced by hospital laboratories, we envision a voluntary, national repository where laboratories and manufacturers contribute standardized analytical and, where appropriate, clinical validation data for both newly developed and modified Food and Drug Administration (FDA)-cleared assays. Data elements such as accuracy, limit of detection, analytical measurement range, analytical specificity, and inclusivity compared with reference determinations would be aggregated within groups representing technically identical assays, enabling cumulative validation and shared use of high-quality evidence. By leveraging these shared data sets, hospital laboratories could implement LDTs in-house with minimal redundant validation, enabling broader access to testing near the point of patient care and faster turnaround times. Manufacturers could use the same data to support applications for expanded intended use of existing FDA-cleared and -approved tests. This framework would strengthen hospital laboratory diagnostic capacity, accelerate test implementation, and improve patient outcomes and healthcare system efficiency.