Abigail Barnes is allergic to peanuts, tree nuts, and shellfish. Her food allergies have landed her in the hospital on six different occasions. She’s not alone: in the U.S., every three minutes a food allergy reaction sends someone to the emergency department.
A few years ago, when Barnes was living in Vermont and attending law school, she heard about the work of Joseph BelBruno. He’s a chemistry professor at Dartmouth College who has done extensive research on polymer sensor technologies and, like Barnes, suffers from severe food allergies.
The two scheduled a meeting, and she discussed her idea for a compact device that could quickly test food for common food allergens. With the help of advisors and fellow researchers, they began their work on the device, Allergy Amulet, and formed a company by the same name that is now based in Madison, WI.
Allergy Amulet is on the verge of closing a $1.1 million seed financing round, says Barnes, the startup’s co-founder and CEO. The company will use some of the money to finish building its latest prototypes and then test them on five separate focus groups, she says. If all goes well, the plan is to do a “pre-sales” launch next year and a full commercial launch in 2018.
New York-based Colle Capital led the round. Other investor groups that participated include Bulldog Innovation Group, Foley Ventures, Gopher Angels, Mendota Venture Capital, and the Wisconsin Medical Society Foundation.
Originally based in the Boston area, Allergy Amulet moved its headquarters to Madison after graduating from Gener8tor—a Wisconsin-based startup accelerator—earlier this year. Allergy Amulet, which currently has five employees, also maintains a research lab in Lowell, MA, Barnes says.
According to statistics from Food Allergy Research and Education, which advocates for Americans with food allergies, nearly half of all fatal food allergy reactions in the U.S. happen outside the home.
“If someone puts your food on the line right next to someone else’s food, and something splashes, that could be an issue,” says Meg Nohe, Allergy Amulet’s director of strategic development.
Considering that millennials eat out more often than members of the previous generations and the number of children in the U.S. with food allergies increased by about 50 percent from 1999 to 2011, the market that Allergy Amulet is hoping to break into appears to be large.
Getting to the point where Allergy Amulet can begin selling its products will not require the startup to receive a 510(k) clearance from the FDA, Barnes says.
“We consulted with a number of experts on this front, and commissioned a legal opinion from a law firm that does a lot of FDA work, and the consensus is that [Allergy Amulet is] not a medical device,” she says. “It’s our understanding that we do not need to seek FDA approval.”
So, how does the device work? Say you’re allergic to peanuts and you go out to eat. You order a dish that, as far as you and the wait staff know, does not contain any nuts. But when your food arrives, you want to be extra sure.
With the process Allergy Amulet is envisioning, you would start by removing a single-use disposable test strip from its packaging, and touching one end of the test strip to
