San Francisco-based uBiome has launched a CLIA-regulated clinical laboratory to provide clinical tests based on its unique microbial assays.

Founded in 2012, the biotech startup engaged the public to provide easily accessible information about their own bodies using high-throughput DNA sequencing technology for the microbiome. uBiome has gathered millions of data points in collaboration with its citizen scientist participants and built unique bioinformatic and lab automation tools. These data have helped develop new clinical assays that will allow doctors and patients to obtain clinically relevant results. uBiome's CLIA laboratory was licensed in December 2014.

Clinical tests will be ordered by patients in collaboration with doctors. Research participants still will be able to participate in studies of the microbiome (including the gut microbiome, skin microbiome, nasal microbiome, genital microbiome, oral microbiome, interdental microbiome and others). Clinical tests will be differentiated clearly from research study results. Interested parties can sign up at www.ubiome.com/clinical.

“uBiome’s mission is to transform research into useful products based on the microbiome. Through our research partnerships with thousands of citizen scientists and dozens of universities, including Harvard, Stanford and UCSF, we have gathered millions of data points and built a set of tools that have enabled us to create clinical tests for doctors and patients,” said Jessica Richman, co-founder and CEO of uBiome.

uBiome will provide a fund for those who cannot afford to purchase clinical tests. Donations will be accepted from both research participants and patients who want to help those in need, and a portion of the proceeds from tests also will go to fund those who cannot afford them. All current and ongoing study participants will receive early access to these tests and other benefits.

The human microbiome has been called the greatest medical discovery of our age. These microbial symbionts are essential collaborators in our health. The correct balance of microbes serves to keep potential pathogens in check and regulate the immune system. Microbes also perform essential functions such as digesting food and synthesizing vitamins. Pathogenic and commensal bacteria play a role in health conditions ranging from autism to yellow fever.

Citizen science, the collaboration between professional scientists and members of the public, allows rapid collaboration on large-scale research questions and translation of the results to practice.

uBiome provides current research participants with a catalog of their own microbes, detailing the microbial composition of each sample, what is known about each type of microbe and the latest scientific research on the role of the microbiome in health, diet and lifestyle. uBiome has received $6.5 million in funding.