IMPORTANCE: The 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. OBJECTIVE: To determine the frequency of use of laboratory-developed tests in an academic medical center system. DESIGN: Quality improvement study analyzing 2021 test order data. SETTING: Academic 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. RESULTS: Of 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. CONCLUSIONS: Laboratory-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.

Jonathan Genzen disclosed role as chief medical officer at ARUP Laboratories, and role as principal investigator for contract research to ARUP Laboratories from Fujirebio Diagnostics. Jenna Rychert and Robert Schmidt had no potential conflicts of interest to disclose.

This study did not receive any funding.

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IRB of the University of Utah waived ethical approval for this work (exemption umbrella protocol 00082990) and protocol 0016184.

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