Viome Kit. (Viome Photo)

Viome Life Sciences has raised $54 million. The funding will bolster the company’s efforts to develop cancer diagnostics and support its separate consumer product division, said CEO Naveen Jain in an interview with GeekWire.

Viome’s consumer division offers services to analyze the microbiome, the collection of microbes in the gut and other parts of the body. The Seattle-area company determines the microbiome composition of stool samples through sequencing of the RNA of bacteria and other organisms.

The company says that its AI-driven algorithms are able to yield personalized recommendations for diet and supplements. Viome customers can also sign up for a $199/month mail service for made-to-order supplements and probiotics.

The company has served more than 300,000 customers and expects to reach one million customers next year, said Jain. The new funding brings Viome’s total raised to more than $125 million.

Viome is also developing a saliva test for head and neck cancers that has “breakthrough device” designation from the U.S. Food and Drug Administration, enabling access to regulatory advice on the path toward full approval.

Viome CEO Naveen Jain. (GeekWire Photo)

“We are going to be launching hopefully, in the next couple of years, several of these diagnostic products for various other cancers,” said Jain, adding that such diagnostics may also be saliva-based.

The company aims ultimately to develop products that might predict whether a patient will respond to a certain drug. “And better yet, that goal really will be to turn the non-responders into responders,” for instance by manipulation of the microbiome, said Jain.

The 155-employee company recently hired Emmanuel Hanon to lead its separate diagnostics and therapeutics division developing such tests. Hanon is the former head of the vaccine group at pharma giant GlaxoSmithKline, which has a partnership with Viome to research the connections between the gut microbiome, cancer, and chronic conditions like autoimmunity.

Viome is also on track to meet its expected goal of $100 million in revenue next year, said Jain. The company also recently paired up with Nordstrom, which has plans to sell Viome kits.

A growing number of studies have shown an association between the composition of the microbiome and conditions such as diabetes and obesity. That’s fueled investor interest in wellness companies focused on the microbiome, such as Zoe and DayTwo.

Companies working on the gut microbiome have raised $1 billion in venture funds since from 2015 to 2020, according to Crunchbase.

But little is known about the effects of specific foods, nutrients or probiotics on microbiome composition and health outcomes. Some researchers are skeptical of Viome’s claims that it can affect microbiome composition and improve health with its “precision” supplements and probiotics.

“I think this is a very interesting and exciting space and I do think there are definite potential implications, down the road,” David Suskind previously told GeekWire. He added: “We are not there in terms of looking at microbiome and making broad recommendation for individuals, as of yet.”

Suskind is a gastroenterologist at Seattle Children’s Hospital and professor of pediatrics at the University of Washington. He also co-founded Nimbal Health last year to provide nutrition and lifestyle advice to people with inflammatory bowel disease, along with medical input and quarterly blood and stool tests to assess their condition.

Viome has released a study saying that its services yield substantial improvement in anxiety, intestinal bowel disease, and severe depression. The data are posted on the preprint service bioRxiv and have yet to be peer reviewed.

Outside researchers have been critical of the study. Participants were Viome customers who filled out clinical questionnaires about their symptoms, a less reliable measure of health status than physician-led documentation. There was no control arm of individuals who did not use Viome’s services. Moreover, the study did not specify which interventions led to the changes in health status.

The methodology is “questionable,” Suskind previously told GeekWire. Jain notes that the study is based on customer data, so is not designed to be a placebo-controlled study.

Viome customers have also complained about long turnaround times for results and the company losing stool samples, leading Jain to apologize to a private Facebook group for users in July. But Viome is back to shorter turnarounds, said Jain, after moving into a new facility in Bothell, Wash. this July.

“Our average turnaround time has now come down to ten days, and we’re really hoping to even bring it down further because now we have such massive capacity,” said Jain.

Jain is the founder and former CEO of InfoSpace and also co-founded public records firm Intelius, as well as Moon Express, which aims to take paying customers to the moon.

Jain’s career has not been without controversy: Infospace was hit hard when the dot-com bubble burst in the early 2000s, leading to a years-long flurry of lawsuits that entangled Jain, other executives and shareholders. Millions of dollars changed hands in a series of legal settlements to resolve the disputes.

Viome, founded in 2016, is Jain’s first life sciences venture.

The latest round of funding includes previous investors Khosla Ventures, WestRiver Group, Glico, Physician Partners, and Bold Capital Group. Ocgrow Ventures is a new investor, and its founder and CEO Harish Consul will join Viome as a board observer.  Previous investors in Viome include Salesforce CEO Marc Benioff.

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