ArticleJournal of clinical microbiology2024
FDA's proposed rule for the regulation of laboratory-developed tests.
Article in Journal of clinical microbiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- Improving isolate recovery and identification of the Shiga toxin type in Shiga toxin nucleic acid test-positive feces.Journal of clinical microbiology · 2026Article
- Organoids in Precision Radiotherapy: Methodological Foundations, Tumor-Specific Evidence, and Translational Roadmaps.Cancer medicine · 2026Review
- Mapping the Literature on the Impact of Gastrointestinal Multiplexed Pathogen Panels on Clinical and Healthcare Utilization Outcomes: A Scoping Review.The journal of applied laboratory medicine · 2026Article
- Navigating and Advancing Market Access for In Vitro Diagnostics: Understanding the Roles of Key Stakeholders and Policy.Open forum infectious diseases · 2025Article
- All you need to know about equipment validation for sterility testing.Journal of clinical microbiology · 2025Review
- The impact of FDA-cleared molecular solutions for BK polyomavirus quantitation.Journal of clinical microbiology · 2025Review
- Genomics and multiomics in the age of precision medicine.Pediatric research · 2025Review
- Advancing clinical biochemistry: addressing gaps and driving future innovations.Frontiers in medicine · 2025Review
- Mitigation of errors on an FDA-approved platform for cytomegalovirus viral load assay.Journal of clinical microbiology · 2024Article
- Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.Journal of the American Medical Informatics Association : JAMIA · 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
- Advances in the Clinical Application of High-throughput Proteomics.Exploratory research and hypothesis in medicineArticle
- Challenges and Opportunities for the Clinical Translation of Spatial Transcriptomics Technologies.Glomerular diseasesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial
Indexed as
Identifiers
What OpenQuestion holds
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.