April 6, 2021

By Michelle Pelletier Marshall, Global AgInvesting Media

According to a recent McKinsey report, more than 30 million people (5.6 million are children) in the U.S. have been diagnosed with food allergies. Their families are impacted as well, resulting in nearly 85 million Americans changing the way they eat at home and in restaurants. This results in one in four Americans making food product purchasing decisions because of food allergies, and lost revenues for food manufacturers and restaurants as well as lost market share for multiple multinational corporations. The top nine food allergens driving this behavior are peanuts, tree nuts, eggs, soy, sesame, fish, shellfish, milk, and wheat.

Seeing this as an opportunity, and focused on the fact that the over-diagnosis rate for food allergies is more than 60 percent, biotech company AllerGenis, founded in 2017, developed a precision diagnostic platform that utilizes current state-of-the-art technology that is significantly more accurate, guiding them in their mission to ensure that food allergy sufferers are better informed around the need for making safe food choices and attaining an improved quality of life.

Under the direction of Hugh Sampson, MD, of the Jaffee Food Allergy Institute of the Icahn School of Medicine at Mount Sinai and the world’s leading expert in food allergy diagnosis, treatment, and management – AllerGenis developed a proprietary platform founded on epitope mapping research that achieves a 95 percent positive predictive value, minimizing false positives in food allergy identification, and supported by clinical outcomes.

The company, based in Hatfield, Pennsylvania, is looking to raise $15 million to capture market share and advance its commercial launch as well as accelerate product development to include assays that better predict allergic reactions to other foods like milk, egg, and tree nuts. The first product in its pipeline – innovative blood-based VeriMap^TM Peanut Diagnostic – which they began testing in June 2020, has been independently validated among multiple and diverse cohorts to diagnose with a high level of confidence.

Global AgInvesting welcomed CEO Jim Garner at a recent webinar to discuss the details about this opportunity, and GAI News caught up with him here for the highlights.

1). What about food allergy diagnosis led AllerGenis to formulate its solution, and wherein lies the market growth potential for these clinical diagnostic products?      

The questions most asked of allergists by caregivers are:

– Is my child allergic?

– If so, how severe is the allergy?

– Will ingestion cause an anaphylaxis reaction?

– Will they outgrow the condition?

– What treatments are available?

Not all of these questions are easily addressed today, or are not addressed at all. The current blood tests fall far short of answering what might happen if a child accidentally ingests a food to which he or she may be allergic. Allergists do the best they can with the tools available but often are left recommending to the caregiver and patient to avoid the food (or foods) all together. Poor diagnostic tools and recommended avoidance leaves huge portions of the population believing they have a food allergy and that some foods are dangerous to their health or even life-threatening.

The market potential for our platform is vast due to the millions of diagnostic testing events which already occur, and the increase in testing which will occur due to our market presence. As many as 70 percent of adults who believe they have a food allergy have never actually been tested. New therapies are emerging for children and adults which will drive additional demand for precision diagnostics. 

2). VeriMap^TM enables the monitoring of individual epitopes level relative to identifying food allergies. Can you please explain how this accuracy is unmatched and important in guiding diagnoses? How is this disruptive in the sector?    

Our products are designed to answer the clinical questions, as well as offer additional information which presently cannot be answered. Twenty-First Century diagnostic techniques are utilized to derive the results – techniques that have not been brought to bear prior to our innovative approaches. Together with scientists at Mt. Sinai, we created a test that accurately and reproducibly measures epitope reactivity to food allergens. And, using artificial intelligence and machine learning, we have developed highly-refined epitope signatures that indicate an allergic patient’s profile.

3). Is the plan so disruptive that the goal is to retest the 30 million diagnosed with food allergies so as to realign the industry? Or just to move forward and revolutionize testing for all future food allergy sufferers?

Both. The incident population – those already living with a diagnosis of food allergy – will benefit from our assays, and if proved to be not allergic, the food industry will benefit as well.

The prevalent population – the newly diagnosed – will benefit by having far more detailed information about their allergy when actually allergic, information specific to them so that they can better understand how they may react to a food product by reading its label.

With the recent approval of Palforzia^® in the U.S. for the treatment of peanut allergy, and the presence of several other therapeutics in the pipeline, the availability of our highly-accurate blood test to establish the diagnosis of peanut allergy will greatly facilitate patient selection for therapeutic intervention.

4). How do you see your technology gaining traction with investors in food and ag?

The impact of food allergies on individuals and families is going to continue in the U.S. for the foreseeable future. This ranges from inconvenience and anxiety at school (grammar through university), at restaurants, summer camps, family vacations, and in the grocery aisle. The food industry is missing sales opportunities due to inaccurate clinical diagnostic tools and rampant over-diagnosis. Caregivers, companies like ours, and food manufacturers can work together to minimize these varied impacts by improving the diagnosis of food allergy, and better managing the condition when present.

5). You’re looking to raise $15 million to develop and market your product further. What type of exit and ROI do you anticipate for investors?

There is considerable interest in technologies that address such a large market. Recently, Nestlé Health Sciences purchased a peanut therapeutics company called Aimmune at a $2.6 billion valuation. In addition, Phadia, a limited-use food diagnostics company, was sold to Thermo Fischer for $3.3 billion. While it may take us three or four years to reach an exit, we would not be surprised if there was similar interest in our business. On that basis, investors would likely make a return that is many times their investment. Those interested in learning more about investing in this opportunity are invited to reach out to Garner directly at jim.garner@allerrgenis.com.

ABOUT JIM GARNER

Jim Garner, who is CEO and board member for AllerGenis, has over 30 years of experience providing products and services to help patients and doctors better diagnose and manage health conditions. He led the effort to establish the company in 2017 to develop precision, data-driven diagnostics to help healthcare providers, patients, and caregivers to more accurately and safely diagnose, assess, and monitor patients with food allergies. Prior to joining AllerGenis, Garner held successive executive leadership roles with life science companies, including Integrated Diagnostics and UnitedHealth Group. He served as a Captain in the U.S. Army where he was Air-Cavalry Troop Commander, among other roles and distinctions. Reach out to Garner at jim.garner@allergenis.com. 

Michelle Pelletier Marshall is contributing editor and author for HighQuest Group’s GAI News and Oilseed & Grain News, and managing editor for its WIA Today blog. She can be reached at mmarshall@highquestgroup.com.