Laboratory-Developed Test Orders in an Academic Health System

ImportanceThe Verifying Accurate Leading-edge IVCT Development Act, if enacted, would create a unified regulatory oversight system for all in vitro clinical tests, including laboratory-developed tests. ObjectiveTo determine the frequency of use of laboratory-developed tests in an academic medical center system. DesignQuality improvement study analyzing 2021 test order data. SettingAcademic medical center (hospital, outpatient clinics, and cancer center) and non-profit national reference laboratory. Main Outcome(s) and Measure(s)Main outcome, not applicable; non-interventional study of retrospective data. Measures include assay type, assay methodology, compliance status (i.e., Food and Drug Administration cleared, approved, and/or authorized assay, laboratory-developed test, and standard method), test order volume, inpatient versus outpatient setting, and provider medical specialty. ResultsOf the 3,016,928 tests ordered in 2021, 2,831,489 (93.9%) were Food and Drug Administration cleared, approved, and/or authorized assays, 116,583 (3.9%) were laboratory-developed tests, and 68,856 (2.3%) were standard methods. Laboratory-developed tests were more commonly ordered in the outpatient versus inpatient setting and represented a higher proportion of the test volume at the cancer center compared to University Hospital (5.6% vs 3.6% respectively). The top 167 laboratory-developed test assays accounted for 90% of the laboratory-developed test volume (104,996 orders). Among the 20 most frequently ordered laboratory-developed tests were mass spectrometry assays and tests used in the care of immunocompromised patients. Internal/family medicine placed the greatest number of orders (1,044,642) and ordered one of the lowest proportions of laboratory-developed tests (3.2%). Non-infectious disease molecular testing made up 8.8% of laboratory-developed tests ordered. ConclusionsLaboratory-developed tests made up a small percentage of the total laboratory tests ordered within the academic health system studied. Regulatory reform proposals should consider the need for both safety and availability of laboratory-developed tests in clinical laboratory settings. KEY POINTSO_ST_ABSQuestionC_ST_ABSHow frequently are laboratory developed tests (LDTs) used in an academic medical center (AMC) setting? FindingsIn this quality improvement study looking at test orders in 2021, 93.9% of test orders were for FDA cleared, approved, or authorized assays, 3.9% were for LDTs, and 2.3% were for standard methods. The top 167 LDT assays accounted for 90% of the LTD volume. MeaningIn vitro diagnostic reform efforts will impact many LDTs assays with relatively low order volumes in AMC settings.