ArticleMethods in molecular biology (Clifton, N.J.)2025
Regulatory Perspectives for Gene Expression-Based Diagnostic Devices.
Article in Methods in molecular biology (Clifton, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Abstract
Genomic methods are a molecular window into the dysregulation of genes and how they may impact human health and disease. They vary widely in how they interrogate the genetic blueprint including epigenetic changes like DNA methylation, or gene expression. They have become variously available and accessible and have become standard methods in oncology or other diseases. This has led to applications of predictive claims for response or progression as companion diagnostics to anti-oncologic therapies or screening for disease whose symptoms are yet to present. The explosion of these technologies has led to renewed efforts by the US Food and Drug Administration to regulate molecular diagnostics. This chapter describes regulation of genomic diagnostics technologies, both for the innovator and the regulator alike.
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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.