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 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 Bethany Henrick, PhD, director of immunology and diagnostics for Evivo. With more than a decade of experience designing and creating rapid, point-of-care diagnostics, Dr. 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, MD, 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 said its Evivo is the only baby probiotic clinically proven to restore Bifidobacterium to a baby's gut and reduce potentially harmful bacteria by 80%. In aclinical trial, Evivo produced rapid, substantial and persistent stabilization of the infant gut microbiome, to help set a foundation for life-long health.
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.