With microbiome testing companies gaining more awareness over the last few years, it’s worth looking into some of the major players and discussing what microbiome testing is, and why it matters.
Companies in this budding area offer personalized solutions to gut problems via their specially-developed microbiome lab tests and supplements.
Viome, a health and wellness company based in Bellevue, Washington, is one of the most prominent in the industry, raising $86.5 million in venture capital last year and an additional $175 million after partnering with retail drugstore giant CVS to sell their testing kits.1
Researchers are beginning to attach more importance to the role gut bacteria plays in overall health, with studies suggesting that imbalances or deficiencies in certain organisms can potentially lead to bowel problems, a weakened immune system, skin issues, and even mental disorders.2
Furthermore, due to the increasing burden on the healthcare system, demand is rising to address gut problems.
According to a 2018 study in the American Journal of Gastroenterology, an estimated two out of every three Americans suffer from symptoms of gastrointestinal disorders.3
In addition, data shows that over 100 million ambulatory visits each year are due to GI diseases, with 14 million of those leading to hospital admissions.
Sadly, 236,000 people on average die each year to GI diseases.
To combat this worrisome reality, the NIH invested $150 million to research and understand the human microbiome.
Based on the findings from this project, biotech and pharma companies have begun developing microbiome tests to analyze gut flora, potentially allowing individuals to repair and replenish their gut-specific microbiome.4
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Why is Gut Health Important?
To understand the importance of microbiome testing, we must first understand why gut health is so important.
First and foremost, a healthy gut ensures that food is properly broken down and nutrients are well-absorbed into the body.
However, what is less commonly known is that a significant portion of the immune system resides in the gut. A balanced microbiome, therefore, may help protect against pathogens and support immune responses.
Interestingly, gut health has also been found to be closely linked to mental health. The gut-brain axis is the communication network that links the gut and brain. Indeed, researchers have found strong correlations between gut problems and mental health conditions such as anxiety and depression.
Additionally, a healthy gut helps regulate inflammation, reducing the risk of chronic diseases like obesity, diabetes, and heart disease.
Gut bacteria also affects metabolism, influencing weight management and energy levels.
Finally, our gut plays an important role in detoxifying the body by processing and removing waste and other harmful substances.
What is Microbiome Testing?
Now that we have discussed the effect of the microbiome on one’s overall health, it becomes clear that understanding one’s unique gut environment can be particularly useful for addressing health problems.
Microbiome testing involves analyzing the ecosystem of microorganisms (bacteria, viruses, fungi, and other microbes) that reside in one’s gut, and as well as other mucosal areas like the mouth and skin.
Companies in this space claim that their tests can provide insights into the composition and activity of one’s microbiome, and can possibly detect deficiencies or imbalances that lead to health problems.5
How Microbiome Testing Works
The way microbiome testing works is simple. First, a sample – usually a stool sample, but sometimes from other mucosal areas – is collected from the individual.
That sample then undergoes DNA or RNA sequencing to identify the different microbes present and their relative abundance.
Advanced algorithms and bioinformatics tools analyze the sequencing data to provide a comprehensive profile of the microbiome.
Based on the analysis, personalized recommendations are provided, which may include dietary changes, probiotics, or lifestyle modifications to improve gut health.
Benefits of Microbiome Testing
Understanding one’s microbiome can help people tailor their diets to support beneficial bacteria and overall health.
For individuals with gastrointestinal issues or other health conditions, microbiome testing can lead to greater knowledge of the causes behind one’s symptoms, allowing one to recognize a and manage symptoms early before they manifest into a full-blown disease.
By improving gut health, individuals may also experience better digestion, mood, and increased energy levels.
Pitfalls of Microbiome Testing
While microbiome testing kits are the product of billions of dollars of research and investment, some scientists have been critical of the industry, with some even labeling it as snake oil.5
Much of the criticism points to the lack of regulations surrounding the industry, as well as its unverifiable claims.
“These companies claim they can determine whether a customer’s microbiome is healthy or in ‘dysbiosis’ — out of balance — and suggest that if so, it could be the reason for one or more health problems. Some of these companies may knowingly mislead consumers, while most appear to engage in questionable practices that are permitted by gaps in the current regulatory framework,” researchers wrote in a paper published in the journal Science.6
Another issue raised in this paper is the lack of consistency among test results, as well as the difficulty of drawing meaningful conclusions from the results.
While scientists agree that understanding the human microbiome could transform future healthcare and prevent disease, they believe more research is needed.
“[Microbiome tests] may be part of our clinical testing,” said Dr Vijaya Surampudi, a nutrition specialist at UCLA Health. “Possible uses might include assessing how a person responds to a particular medication or food. But we’re not there yet.”6
Companies such as Viome, Parallel Health, and Tiny Health acknowledged these concerns, but argued that their claims were supported by their proprietary data and methods.5
Nevertheless, companies and scientists in the space agree that there needs to be more consensus and regulations in place.
Tiny Health, which recently received $9 million in a Series A funding round, has made strides to obtain FDA approval for its infant tests through clinical studies.
Viome further hopes that the data they receive will fuel more research and generate more insight. Like genealogy company 23andMe, Viome is looking to capitalize on the data, possibly selling it to drug manufacturers.
Microbiome Testing Companies at a Glance
Thus far, there are 31 companies offering microbiome testing. These range from established pharmaceutical manufacturers to biotech startups.7
Over the past several years, startups in this sector have obtained substantial investments and partnerships worth billions of dollars.
The companies below vary in their focus areas, from gut health and metabolic health to pediatric and skin microbiomes. They also use differing testing methods, with certain companies utilizing technologies like RNA sequencing, AI, and metagenomic sequencing to offer personalized health insights and solutions.
Funding for these companies varies significantly, with some raising substantial amounts to support their research and development efforts. In addition, their business models may differ, with some companies focusing on direct-to-consumer sales and others facing the pharmaceutical market.
Breakdown of Main Microbiome Testing Companies
1. Viome
Viome offers personalized health solutions by analyzing the gut and oral microbiomes. Their services include at-home testing kits that assess microbial composition and provide tailored dietary recommendations, supplements, and probiotics.
The company aims to be at the forefront of personalized and preventative medicine, using RNA technology, AI, and a massive cache of biological data to assess individuals’ genetic expression and tailor personalized health strategies.
“Hypothetically we can do a skin microbiome and come up with personalized skin cream. We can do a scalp microbiome and come up with personalized shampoo,” founder Naveen Jain said in an interview with Fierce Healthcare.
Viome has also recently announced a pre and probiotic toothpaste called MyBiotics, based on one’s personalized oral microbiome, which aims to improve oral hygiene and prevent gingivitis and tooth decay.
- Unique Features:
- Proprietary RNA sequencing technology.
- AI-driven health insights.
- Focus on both gut and oral microbiomes.
2. uBiome
(Note: The company filed for bankruptcy in 2019, but its impact and early contributions are still noteworthy)
One of the early pioneers in microbiome testing, uBiome provided microbiome sequencing services directly to consumers, offering insights into gut health. uBiome raised approximately $110 million before its bankruptcy in 2019.
- Unique Features:
- Crowdsourced microbiome data.
- Provided reports comparing users' microbiomes to those of others.
3. DayTwo
DayTwo specializes in gut microbiome analysis to provide personalized nutritional recommendations, particularly aimed at managing blood sugar levels and metabolic health.
- Unique Features:
- Focus on metabolic health and diabetes management.
- Personalized meal plans based on gut microbiome.
The company raised $85 million in funding as of their latest round in July 2021.
4. Thryve (now known as Ombre)
Thryve (Ombre) offers gut microbiome testing and personalized probiotic supplements. Users receive dietary recommendations and custom probiotics based on their microbiome analysis.
- Unique Features:
- Custom probiotic formulations.
- Integration of dietary recommendations with probiotic supplements.
Thryve raised $1.4 million in a seed round in 2019.
5. Sun Genomics
Sun Genomics provides custom probiotics based on gut microbiome testing. Their flagship product, Floré, offers personalized probiotic supplements tailored to individual microbiome profiles.
- Unique Features:
- Custom probiotics tailored to individual microbiomes.
- Continuous monitoring and adjustments of probiotic formulations.
The company raised $11 million in a Series A round in September 2021.
6. Microba
Microba offers microbiome testing services that provide insights into gut health. They focus on high-resolution metagenomic sequencing to deliver comprehensive reports on gut microbiota.
- Unique Features:
- High-resolution metagenomic sequencing.
- Detailed gut microbiome analysis with actionable health insights.
Microba raised $22 million in a Series B round in December 2022.
7. Tiny Health
Tiny Health focuses on pediatric microbiome health, offering testing and insights for infants and young children. They aim to improve health outcomes in early childhood by analyzing and optimizing the infant gut microbiome.
- Unique Features:
- Specialization in infant gut health.
- Scientific validation of what constitutes a healthy infant microbiome.
Tiny Health is currently undergoing clinical studies to obtain FDA approval, and has partnered with lab testing provider Rupa Health to provide access to microbiome testing for health practitioners.
8. Parallel Health
Parallel Health offers phage-based treatments that cater to an individual's skin microbiome. They use advanced genomics and AI to develop personalized skincare solutions.
- Unique Features:
- Phage-based treatments for skin microbiome.
- Use of AI and genomics for personalized skincare.
The company is building a dataset for clinical validation.
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Key Takeaways:
- Gut health is a key factor contributing to overall well-being, enabling proper digestion and nutrient absorption, supporting the immune system, and maintaining mental health. It also helps regulate inflammation and metabolism,
- Microbiome testing involves analyzing the community of microorganisms in one's gut through DNA or RNA sequencing of stool samples. This analysis provides insights into the composition and activity of the microbiome, leading to personalized health recommendations.
- Viome, a leading company in the microbiome testing industry, has raised substantial funds, and partnered with CVS to offer their testing kits. They utilize proprietary RNA sequencing and AI-driven health insights for personalized health solutions, including dietary recommendations and probiotics.
- With an increasing burden on the healthcare system due to gastrointestinal disorders, microbiome testing is gaining traction as a potential solution. An estimated two out of every three Americans suffer from GI symptoms,
- Despite the potential benefits, microbiome testing faces criticism due to a lack of regulations, inconsistent test results, and unverifiable claims. Researchers have called for more scientific consensus and regulatory frameworks to validate the industry's practices.
- Several companies are active in the microbiome testing space, each with unique features and focus areas. Examples include DayTwo (metabolic health), Thryve/Ombre (custom probiotics), Sun Genomics (personalized probiotics), Microba (detailed gut analysis), Tiny Health (pediatric microbiome health), and Parallel Health (skin microbiome treatments).
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