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Clinical Screening Test for Gut Health Developed

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uBiome has released a preprint of a publication submitted for peer review, entitled “16S rRNA Gene Sequencing as a Clinical Diagnostic Aid for Gastrointestinal-related Condition.

The pre-print comes alongside the announcement of the world’s first sequencing-based clinical microbiome test, SmartGut™. SmartGut™ enables physicians and patients to access a comprehensive microbiome screening test with a simple, at-home sample collection, to identify important commensal and pathogenic microorganisms.

The preprint details the simultaneous detection of 28 microbial genera and species associated with gut conditions using next generation sequencing. In addition to advancement in the detection of microorganisms, uBiome’s collection method improves the patient experience by allowing for collection of small DNA samples instead of the larger, traditional collection methods used in culture-based methods. 

In the article, uBiome demonstrates the power of using a citizen science data set by using the tens of thousands of datapoints from citizen scientists -- all collected under a human subjects’ protocol approved by an IRB -- to define a healthy range based on hundreds of healthy individuals. Because many clinically relevant microorganisms associated with disease can be present at some level in healthy individuals, these established ranges allow the new method to clearly identify levels associated with specific conditions and diseases.

Dr. Daniel Almonacid, Director of Bioinformatics at uBiome, notes: “One of our team’s driving ambitions in developing the new tool was to find ways to accelerate clinical testing while also ensuring rigorous analytic performance characteristics. The new methodology therefore enables microorganisms to be identified automatically by a bioinformatics software, leaving no need for human interpretation or human error.”

Dr. Zachary Apte, co-founder and CTO of uBiome, explains: “We developed microbiome reference ranges based on healthy participants selected from the tens of thousands of citizen scientists who have participated in the uBiome research study. This is one of the first full demonstrations of uBiome's model -- empowering citizen scientists to explore their own microbiome and utilize their contributions en masse to develop the next generation of microbiome science and products. As a thank you for everyone’s vital contributions to the establishment of these ranges, we will announce new ways for citizen scientists to get involved soon.”


Story from uBiome. Please note: The content above may have been edited to ensure it is in keeping with Technology Networks’ style and length guidelines.


Almonacid, D. E., Kraal, L., Ossandon, F. J., Budovskaya, Y. V., Cardenas, J. P., Richman, J., & Apte, Z. S. (2016, October). 16S rRNA Gene Sequencing as a clinical diagnostic aid for gastrointestinal-related conditions. Cold Spring Harbor Laboratory Press. doi:10.1101/084657