Modern medicine has a measurement for almost every critical function in our body - cholesterol, glucose, blood pressure, heart function, lung capacity.

Yet when a patient walks into a doctors office suffering from persistent digestive issues, it’s still a guessing game. A patient might be told to take an antacid, handed a stronger prescription version, encouraged to try probiotics, or simply to “change your diet”.

The reality is doctors don’t have a good way to identify the root cause of the problem, leaving patients frustrated and conditions unresolved.

It’s a condition medically known as Dysbiosis, an unhealthy imbalance in the gut microbiome. Tens of millions suffer from it unknowingly.

Now, with more than half of Americans suffering from a chronic disease, recent research shows that Dysbiosis is a critical driver of many of these conditions including neurodegenerative, cardiovascular, metabolic, and gastrointestinal diseases.

Yet despite the critical role the gut microbiome plays in maintaining our overall health, there is no scientific way to measure its functional health—until now.

32 Biosciences, backed by science partnerships with the University of Chicago and the University of Wisconsin, is engineering proprietary gut health solutions on two levels:

For the first time ever, doctors whose patients come to them with gastrointestinal issues will be able to precisely analyze the actual health of the patient's unique gut microbiome and recommend a personalized treatment.

Both pathways are entering the FDA approval process after development by scientific founders who’ve received a collective $119 million in funding from the NIH (National Institutes of Health).

The diagnostic test and the first pharmaceutical treatment open the door to a initial $19.4 billion-dollar market opportunity serving tens of millions of patients.

32 Biosciences is developing a first of its kind diagnostic platform to assess the functional health of the gut microbiome. They are doing so with incredible scientific precision.    

The microbiome test quantitatively measures 20 proven metabolites and provides a standardized reference range for healthy levels of each metabolite.  Levels that are too low or too high indicate Dysbiosis, now recognized as a critical factor driving chronic diseases ranging from cardiovascular disease to neurodegenerative disease to diabetes.

The test also returns a total score that doctors and patients can easily follow.  From 0-20 is considered healthy.  Higher than 20 indicates issues in need of microbiome-based intervention.

Most importantly, the data pinpoints the specific dysfunction of the gut microbiome where targeted, personalized treatment is needed.

32 Biosciences is moving to make GB-0001 the very first FDA cleared diagnostic tool that assesses the gut microbiome.  

IBS is the first of many indications planned for diagnosis with this type of testing. Future conditions to address may include neurodegenerative disease, cardiovascular disease, obesity, and diabetes. In fact, the test will soon be used in a NIH-funded study on Parkinson’s and the microbiome.    

By quantitatively defining what it means to have a “healthy” gut microbiome, GB-0001 allows physicians to precisely diagnose what is causing an “unhealthy” gut microbiome. It also enables them to recommend personalized treatment plans that reverse Dysbiosis and return a patient’s gut microbiome to health.

It’s a medical reality. After decades of using (and even overusing) antibiotics, we are losing the fight against antibiotic resistant bacteria.  In fact, a recent prominent study showed 59% of bacteria that caused surgical site infections (SSIs) were resistant to the preventive antibiotic administered prior to surgery.

The field is in desperate need of new strategies to combat infection.

Nowhere is the need more apparent than in the 300,000+ SSIs that occur per year, many of which could be prevented through the 32 Biosciences’ first of its kind therapeutic (CS-0003).

Today, most treatments focus solely on killing “bad” bacteria present in the infection. There are two problems with this approach.  Good bacteria are often killed and antibiotic resistant bacteria are not affected.

32 Biosciences is taking an entirely different approach - a three-pronged strategy offering both prevention and treatment by:

• Preventing harmful bacteria from ever being activated
• Promoting the growth of beneficial bacteria
• Strengthening the gut mucous barrier to prevent bacteria from escaping

All this is accomplished by the patient mixing an easy to drink powder with water.  

Further applications are envisioned for life-threatening conditions like sepsis, wound infections, colon cancer recurrence, chemotherapy toxicity, and more. 

The two microbiome-based interventions discussed today - GB-0001 to measure gut microbiome health and CS-0003 to prevent surgical site infections – are only the beginning of 32 Biosciences’ work.

While there are many “solutions” marketed today, ranging from teas to shakes to vitamins to prebiotics or probiotics added to foods, none of them are scientifically validated or FDA regulated.

The 32 Biosciences mission addresses that gap at every level and places the company on the cutting edge of a field with incredibly broad potential, gut microbiome medicine.  

The company is working to address a pattern that unfolds in every “advanced” society.

Expanded consumption of highly processed foods, overuse of antibiotics, and exposure to harmful chemicals are primary factors in Dysbiosis.  Increasing evidence shows this imbalance in the gut microbiome leads to the type of systemic inflammation now viewed as a major contributor to neurodegenerative, cardiovascular, metabolic, and gastrointestinal disease.

The 32 Biosciences testing platform identifies precise problems within the gut microbiome, allowing clinicians to prescribe precise treatments.

Highly targeted treatments aim to prevent life-threatening conditions, starting with surgical site infections and moving on to critical areas like sepsis, wound care, chemotherapy toxicity, and more.

Early work is also underway on the development of science-based nutritional products to restore and maintain gut microbiome health, looking to prevent imbalances and the diseases that can result before they ever arise.

The knowledge gained via testing procedures like GB-0001 can also be used to build a database of gut microbiome health information. The collected data could unlock the mechanisms that enable chronic disease, thus allowing for the development of precision therapeutic and diagnostic candidates that speed the drug development process.

The work of 32 Biosciences holds the potential to change the very way human health is measured as well as the way medicine approaches the prevention and treatment of human disease.

The microbiome sector is emerging as a strategic opportunity in healthtech with multiple paths available to biotech companies looking for an exit strategy.

The 32 Biosciences plan currently reflects moving down the first of those paths, an Initial Public Offering, with a filing anticipated in 2027.

Major pharma and biotech firms are also ramping up acquisitions and partnerships of young biotechs with drug discovery platforms and promising drug candidates. Prometheus Biosciences was purchased by Merck for $10.8 billion, providing an estimated 200x return for their earliest investors.

Private equity is also actively investing in scientifically advanced drug development companies, looking to benefit from the potentially groundbreaking therapies these firms  produce. Q1 2024 alone saw $1.9 billion invested across 36 deals from players as large as BlackRock Life Sciences.