10105730Improvement of microbiome sample processing and analysis using novel testing standardsClosedCollaborative R&DInnovate UKSalient Labs Ltd is a UK-based biomedical diagnostics SME with a focus on microbiome analysis. Microbiomes are integral to an individual's health, and microbiome composition can be used to diagnose or predict the risk of disease. The oral microbiome has been implicated in both dental disease and systemic diseases such as diabetes and cancer. Disease diagnosis requires accurate profiling of microbiome composition (e.g. through metagenomic shotgun sequencing), which in turn relies on standards for the validation of laboratory and bioinformatic protocols. This project proposes the development of standard materials for oral microbiome analysis, specifically purified DNA from real-world oral microbiome samples that has been characterised by our collaborator LGC using digital PCR for absolute quantification of selected target microbes. No standards currently exist that reflect the complexity and variability of the oral microbial population. Bioinformatic analysis of sequencing data requires parameterisation to fit the demands of a particular microbiome type. These parameters must also be able to capture the variation that occurs within a sample type, for example due to disease. Our approach will generate standards that capture this variability and allow for more comprehensive optimisation of our bioinformatic analyses and thus greater accuracy than can be achieved by using conventional 'single-state' microbiome standards. We anticipate that this approach will be expanded to more target organisms and other microbiome types in future research. Salient has an established team of outstanding scientists. The project team have a combined experience of over 30 years in top level academic and commercial institutions. LGC are global experts in testing and standardisation. Salient and LGC possess state of the art capabilities for microbiome sequencing and digital PCR respectively. This project will result in Salient being able to offer market-leading oral microbiome analysis as a service to academic or commercial partners or as part of at-home testing kits for individuals, which we will market alongside our existing microbiome tests. Wider benefits of the project include greater value for money for test end users; a healthier UK workforce (mitigating \>£36M/year in lost work due to oral health (the-dentist.co.uk, 2016)); and improved accessibility to health diagnostics across regional and ethnic groups. At-home testing in general helps to maximise accessibility to healthcare, including to populations who may be unwilling or unable to visit their GP. We hope that development of an improved approach to microbiome standardisation will lift quality across the industry.