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.
EU Clears Claros Diagnostics' POC PSA Immunoassay System
European regulators have cleared Claros Diagnostics' quantitative point-of-care protein immunoassay PSA IVD to be sold throughout the European Union, a move that "will facilitate the commercial rollout of the system in all of the major world markets that we will pursue,” the company said today.
The lab-on-a-chip-based test, which takes around 15 minutes to run, comprises a portable analyzer and credit card-sized disposable. It is the first of the company's plan to "create a suite of products for the point-of-care market.”
To that end, Claros said it is "preparing" to launch a urology IVD for the EU market and is in the "process" of attaining regulatory clearance in other markets, including the US.
As my colleague Tony Fong wrote in ProteoMonitor April, the company is currently conducting clinical trials as it prepares to submit the test with the FDA.
The aim of the Woburn, Mass.-based company is to "leverage the differentiation of our platform technology across other verticals as a vehicle to transition virtually any complex immunoassay from the reference laboratory to the point-of-care."
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