Connection Between Epigenome, Selective Mutability, Evolution, and Human Disease
Li, Harris et al., PLoS Genetics
Researchers at the Baylor College of Medicine and elsewhere propose a "connection between the epigenome, selective mutability, evolution, and human disease" based on the findings of their study on associations of structural mutability with germline DNA methylation and with non-allelic homologous recombination mediated by low-copy repeats. "Combined evidence from four human sperm methylome maps, human genome evolution, structural polymorphisms in the human population, and previous genomic and disease studies consistently points to a strong association of germline hypomethylation and genomic instability," the Baylor-led team writes.
FDA's New Draft IVDMIA Guidance Still Not Clear For Some Industry Stakeholders
The new guidelines include a more detailed definition of what the agency considers an IVDMIA, provisions for orphan disease testing, and additional information on the agency’s risk-based approach. However, the Coalition for 21st Century Medicine maintains that the agency still hasn’t gotten it right.
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