Biocollective, LLC, The — Department of Health and Human Services SBIR Phase I: 400

Description

Contact PD PICanoRaul JCompanyThe BioCollectiveLLCApplication IdentifierFOAPASUMMARY Significant advances in high throughput sequencing and new tools for analyzing microbiomes as well as the demonstrated value of microbiome research in human health are driving rapid development in this fieldThis rapid and exponential increase in microbiome related studieshoweveremploys a stochasticnon standardized approach to microbiome researchAs a consequencea large volume of data has been gathered and interpreted in different waysnot readily comparable among laboratories and thereforeless usefulThis must be remedied if microbiome science is to pay a central role in diagnosis and therapy of disease conditionsBecause microbial community analysis can be biased by multiple technical factorse gstorage conditionsDNA extraction or PCR amplificationreference standards are essential to monitor and evaluate such variables as currently used in clinical chemistry and microbiologyWe propose that well characterizedhomogeneous and stable reference standards can be used as quality control to routinely monitor the laboratory process and to validate new methodsThe results obtained during our Pilot Study indicate that it is feasible to construct a whole genome reference standard that can be homogenized to provide a well defined microbiome composition that is statistically validated and useful for quality control of microbiome studiesFrom these resultsthe development of a reference standard is feasiblewith high likelihood of successWe will develop an SOPoptimize the process and scale to commercial quantities the manufacturing of Microbiome Reference StandardsMRSEach iteration of the manufacturing process will undergo internal validations to assess achieved homogeneity and stability during prolonged storageas well as data reproducibilityThe market for the proposed MRS is a new market in the field of microbiome researchWe are not aware of any similar commercial product availableOur initial marketing efforts will be focused on developing key partnerships and developing products that will be sold and distributed through their existing sales channelsThe proposed MRS products offers a solution for the unmet need for comprehensive microbiome quality controladdressing the need of the scientific community and NIH Human Microbiome ProjectThe MRS proposed hereprepared and made available at commercial scalewill provide microbiome practitioners with a much neededand currently unavailable reference for quality control and validation of microbiomes and serve as gold standard for human microbiomesSummaryAIContact PD PICanoRaul JCompanyThe BioCollectiveLLCApplication IdentifierFOAPAPROJECT NARRATIVE The goal is to develop and validate a manufacturing protocol and Standard Operating ProcedureSOPfor the production and characterizationin commercial quantitiesof microbiome reference standardsMRSfrom human sources that can be used to identify and quantify sources of bias in the measurements processfrom DNA extraction to library preparation to NGS to bioinformatic interpretation as well as to benchmark the results in clinical and diagnostic effortsThese MRS could also be used as quality control material to routinely monitor the measurement process and identify run to run variation as well as for assessing and validating new protocols and methodsThe BioCollective has the experienceexpertiseand track record to develop a reference standard that will be useful and applicable in a wide range of microbiome related applications and will fill this obvious and necessary void and be instrumental in improving the quality and value of future microbiome research and discovery effortsProject NarrativeAI