A clinically validated human capillary blood transcriptome test for global systems biology studies

Abstract

Chronic diseases are the leading cause of morbidity and mortality globally. Yet, the majority of them have unknown etiologies, and genetic contribution is weak. In addition, many of the chronic diseases go through the cycles of relapse and remission, during which the genomic DNA does not change. This strongly suggests that human gene expression is the main driver of chronic disease onset and relapses. To identify the etiology of chronic diseases and develop more effective preventative measures, a comprehensive gene expression analysis of the human body is needed. Blood tissue is easy to access and contains a large number of expressed genes involved in many fundamental aspects of our physiology.We report here the development of a whole blood transcriptome clinical test that is high throughput, automated, inexpensive, and clinically validated. The test requires only 50 microliters of blood from a finger prick, enabling access by diverse populations that have been traditionally underrepresented in clinical research. The transcripts in the samples are preserved at the time of collection and can be stored and/or transported at ambient temperatures for up to 28 days. The sample preservative protects integrity, while also inactivating all pathogens (bacteria, fungi, and viruses), enabling safe transportation globally. Given its unique set of usability features and clinical performance, this test should be integrated into longitudinal, populationscale, systems biology studies.

Data-driven precision nutrition improves clinical outcomes and risk scores for IBS, depression, anxiety, and T2D

“…Results consist of quantitative strain, species, and genus level taxonomic classification of all microorganisms, and quantitative microbial gene and KO (KEGG Ortholog, KEGG = Kyoto Encyclopedia of Genes and Genomes) expression levels. The matching blood samples were collected and analyzed as previously described [45]. Briefly, blood samples are collected by the study participants using the Viome commercial kits that included ambient temperature preservation solution and pre-paid return mailers.…”

“…This approach is 100% algorithmic and data-driven, and there are no humans involved in making the nutritional recommendations. The molecular data are obtained from stool or a combination of stool and blood samples using highly accurate and reproducible, clinically validated, and clinically licensed metatranscriptomic tests [42] [43]. These data are used to quantify the activity of microbial metabolic pathways, specific microbial taxa (at the strain level), and human gene expression levels.…”

Evidence-based precision nutrition improves clinical outcomes by analyzing human and microbial molecular data with artificial intelligence

“…Results consist of quantitative strain, species, and genus level taxonomic classi cation of all microorganisms, and quantitative microbial gene and KO (KEGG Ortholog, KEGG = Kyoto Encyclopedia of Genes and Genomes [45]) expression levels. The matching blood samples were collected and analyzed as previously described [42]. Brie y, blood samples are collected by the study participants using the Viome commercial kits that included ambient temperature preservation solution and pre-paid return mailers.…”

“…This approach is 100% algorithmic and data-driven, and there are no humans involved in making the nutritional recommendations. The molecular data are obtained from stool or a combination of stool and blood samples using highly accurate and reproducible, clinically validated, and clinically licensed (meta)transcriptomic tests [42] [43]. These data are used to quantify the activity of microbial metabolic pathways, speci c microbial taxa (at the strain level), and human gene expression levels.…”

A clinically validated human saliva metatranscriptomic test for global systems biology studies

“…Saliva samples were lysed by bead beating in the RNA preservative buffer (RPB), as previously described [40,41]. RNA was extracted using silica beads and a series of washes, followed by elution in molecular biology grade water.…”