First-Ever Rapid Response Test for Levels of Bifidobacterium in Baby’s Gut Microbiome

Evivo Stool Test Prototype Provides Clear Window into Infant Gut Health

DAVIS, Calif., September 20, 2018 – Evolve BioSystems, makers of Evivo® baby probiotic, today unveiled its prototype for the first-ever rapid-response infant gut microbiome screening test. Using a small stool sample collected from a diaper, the test will detect levels of Bifidobacterium, a group of beneficial gut bacteria that are especially critical during infancy.


The Evivo stool test will allow doctors to discern whether babies have high or low levels of this key beneficial bacteria, Bifidobacterium. Evivo’s quick and non-invasive test measures the presence of markers that indicate low or high levels of good Bifidobacterium, such as acetate and lactate. A stool sample containing high levels of these markers will be strong enough to change the test’s liquid display from pink to yellow, indicating high levels of Bifidobacterium. The liquid will remain pink if a sample has low levels of acetate and lactate, indicating that Bifidobacterium is missing and that key nutrients from breast milk, human milk oligosaccharides (HMO), are being wasted. Evivo has commenced rigorous clinical trials with the prototype to demonstrate the results from infant stool samples.

 Point-of-Care Diagnostic Expert Turns Focus to the Infant Gut

The development of the prototype is led by Dr. Bethany Henrick, Ph.D., Director of Immunology and Diagnostics for Evivo. With more than a decade of experience designing and creating rapid, point-of-care diagnostics, Henrick was formerly an integral part of the team that developed and optimized the world’s fastest point-of-care HIV test in 2005.

 “This is the first and only point-of-care screening test designed to identify infants that do not have enough Bifidobacterium levels to create a stable infant gut microbiome,” said Dr. Henrick. “With recent research indicating most babies born after 1980 do not acquire Bifidobacterium at birth, our ability to detect significant levels of Bifidobacterium gives pediatricians and parents an immediate indication of whether or not their baby has this beneficial gut bacteria that set them up for lifelong health.”

Identifying a Disappearing, Yet Critical Piece of Gut Health

Dr. Henrick’s previously published findings, which are the basis for the Evivo test, show an inverse correlation between rising infant fecal pH, reduced acetate and lactate, and lower levels of beneficial Bifidobacterium, proving that the infant gut microbiome has been rapidly changing over the last three generations. In the past, babies acquired Bifidobacterium from their mother during childbirth, but due to the increased use of modern medical practices such as antibiotics, C-sections and formula feeding, nine out of 10 babies born in the U.S. today no longer acquire it. The generational loss of this good bacteria in the infant gut allows for potentially harmful bacteria such as E. Coli and Clostridia to thrive, which are linked to higher risk of short- and long-term health issues such as colic, eczema, allergies, diabetes, and obesity.

“Currently there is no way to easily determine whether a baby is colonized with healthy bacteria,” said Mark Underwood, M.D., Chief of Neonatology at UC Davis Medical Center. “The ability to quickly measure levels of Bifidobacterium in a stool sample would enable pediatricians to identify babies with low levels of these beneficial bacteria and take appropriate action.”

Evolve BioSystems’ Evivo is the only baby probiotic clinically proven to restore Bifidobacterium to a baby’s gut and reduce potentially harmful bacteria by 80 percent. In a landmark clinical trial, Evivo produced rapid, substantial and persistent stabilization of the infant gut microbiome, to help set a foundation for life-long health.

About Evolve BioSystems
Evolve BioSystems, Inc. is a privately-held microbiome company dedicated to developing the next generation of products to establish, restore, and maintain a healthy gut microbiome. Evolve recently completed a $40M Series C round of funding co-led by the Bill & Melinda Gates Foundation and Horizons Ventures, the venture division of the Li Ka Shing Foundation.

Evolve is a spin-out from the Foods for Health Institute (FFHI) at the University of California, Davis and builds on more than a decade of research into understanding the unique partnership of the infant gut microbiome and breast milk components. Having led to the development and commercial launch of products to resolve newborn gut dysbiosis, including Evivo® for infants, Evolve's discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle. In addition to the landmark proof-of-concept trial, Evolve is undertaking further clinical studies to build out its suite of microbiome-based solutions.

Tracy Shafizadeh