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| NYU's Maria Dominguez-Bello |
A couple of months ago, New York University's Maria Dominguez-Bello garnered headlines for a small pilot study she led in which a few newborn babies delivered by C-section were swabbed with their mother's vaginal fluid. She then determined that the skin and oral microbiomes of the swabbed infants were changed by the process, making them similar to babies delivered vaginally and theorizing that the coating of microorganisms could help assure a healthier future for the infants.
Rob Knight, a microbiologist at the University of California, San Diego, who participated in the study, noted to Nature that it's all based on simple common sense; a growing understanding of the microbiome would lead you to conclude that missing out on a trip through the vaginal canal at birth would deny babies a natural health benefit. There is, after all, evidence that babies delivered by caesarian are exposed to a higher risk of conditions like asthma and obesity. He'd even done the simple procedure with one of his own children delivered by C-section.
To Boston-based PureTech, a company that specializes in jump-starting companies that are developing a range of new treatments for everything from obesity to hair loss, that theory looked like a sound foundation for a new biotech business.
PureTech is launching Commense, which has gained an exclusive license to the technology that was used in the NYU study, listing Dominguez-Bello as a company co-founder and Knight as a member of the biotech's scientific advisory committee. They're joined on the SAB by a prestigious group, including NYU Langone Medical Centre's Martin Blaser and Sam Kass, a former childhood health adviser to the White House.
PureTech's statement also included a laundry list of potential health benefits, including avoiding diseases like diabetes, Crohn's disease and even autism.
But there's no clear evidence of a health benefit, or an unmet medical need, the required starting point for most biotech investors. And PureTech will now set out to develop the technology and acquire more data to demonstrate the benefits of a simple DIY procedure that is already being used in hospitals around the world.
Shortly after the NYU study was published, a group of U.K. scientists sounded an alarm about the increasingly popular--and controversial--process, which is sometimes called "vaginal seeding."
"I think it would be helpful to have some guidelines on this, [but] it's very hard to make guidelines when you have almost no evidence," Aubrey Cunnington of Imperial College London told CNN.
The causal link between C-sections and autism, for example, is tenuous. A large study last year concluded that while you could track a 20% increase in the risk of autism among children born by C-section, the cause was uncertain, and when compared with siblings the link was more likely due to underlying genetic or environmental causes that triggered a higher risk for both C-sections as well as autism.
Alexander Khoruts, a gastroenterologist at the University of Minnesota, told Nature that establishing a direct link between the procedure and better health later in life will be very hard to do. In the meantime, he expressed concern that more mothers will start demanding the same procedure, which bears certain risks in passing on some distinctly unhealthy infections.
But the researchers are now at work on a follow-up study to track 75 newborns for a year to demonstrate a lasting effect on the microbiome of toddlers. And Commense will set out to develop other ways they can develop new tech for safely transferring microbes to children--whatever the benefit.
- here's the release