ReviewAmerican journal of clinical pathology2019
Regulation of Laboratory-Developed Tests.
Review in American journal of clinical pathology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed.
- A guide for the deployment, validation, and accreditation of clinical digital pathology tools.Journal of pathology informatics · 2026Article
- Clarifying validation terminologies in healthcare.NPJ digital medicine · 2026Article
- New insight into RNA biomarkers in neuropathic pain: a clinician-neuroscientist roadmap to translational testing and treatment monitoring a clinical review.Frontiers in pain research (Lausanne, Switzerland) · 2026Review
- Revisiting Thyroglobulin Measurement: Current Methods and Future Perspectives Using Dried Blood Spot Sampling for Enhanced Clinical Practice.Metabolites · 2025Review
- Genomics and multiomics in the age of precision medicine.Pediatric research · 2025Review
- Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- Unraveling the complexity of PD-L1 assays: a descriptive review of the methodology, scoring, and practical implications.Frontiers in oncology · 2025Review
- Integrating spatial omics with routine haematoxylin and eosin in formalin-fixed paraffin-embedded: a step-by-step clinical workflow.F1000Research · 2025Review
- Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing.NPJ digital medicine · 2024Article
- The Role of Mechanistic Biomarkers in Understanding Acetaminophen Hepatotoxicity in Humans.Drug metabolism and disposition: the biological fate of chemicals · 2024Review
- The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing.Practical laboratory medicine · 2024Article
- FDA's proposed rule and its regulatory impact on emerging and reemerging neglected tropical diseases in the United States.PLoS neglected tropical diseases · 2024Review
- Application of Clinical Blood Metabogram to Type 2 Diabetes Mellitus.Metabolites · 2024Article
- Application of clinical blood metabogram for diagnosis of early-stage Parkinson's disease: a pilot study.Frontiers in molecular biosciences · 2024Article
- Patient safety and healthcare quality of U.S. laboratory developed tests (LDTs) in the AI/ML era of precision medicine.Frontiers in molecular biosciences · 2024Article
- RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations.Journal of clinical microbiology · 2023Article
- Current clinical practices and challenges in molecular testing: a GOAL Consortium Hematopathology Working Group report.Blood advances · 2023Article
- Clinical Blood Metabogram: Application to Overweight and Obese Patients.Metabolites · 2023Article
- Quantitative tandem mass spectrometry in the clinical laboratory: Regulation and opportunity for validation of laboratory developed tests.Journal of mass spectrometry and advances in the clinical lab · 2023Review
- Comparison of two highly sensitive benzodiazepine immunoassay lab developed tests for urine drug testing in clinical specimens.Journal of mass spectrometry and advances in the clinical lab · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of conventional IVDs and laboratory-developed tests (LDTs).
methodsA concise literature-based review of LDT regulation is presented followed by a discussion of key concerns pertinent to clinical laboratories that should be considered in future IVD regulatory reform efforts.
resultsKey issues identified include the importance of fostering innovation, preserving patient safety, protecting the practice of laboratory medicine, and minimizing undue regulatory burden. Clinical laboratories are not equivalent to manufacturing facilities and would therefore encounter challenges in implementing device-centric regulatory oversight models.
conclusionsIt is imperative that a clinical laboratory perspective on LDTs is understood and incorporated prior to advancement of future legislative proposals.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.