People with life-threatening allergies live in constant fear of coming into contact with deadly allergens. Researchers estimate that about 32 million Americans have food allergies, with the most severe being milk, egg, peanut, tree nuts, wheat, soy, fish, and shellfish.
"It is important to understand that just several years ago, this would not have been possible."
Every three minutes, a food allergy reaction sends someone to the emergency room, and 200,000 people in the U.S. require emergency medical care each year for allergic reactions, according to Food Allergy Research and Education.
But what if there was a way you could easily detect if something you were about to eat contains any harmful allergens? Thanks to Israeli scientists, this will soon be the case — at least for peanuts. The team has been working to develop a handheld device called Allerguard, which analyzes the vapors in your meal and can detect allergens in 30 seconds.
Leapsmag spoke with the founder and CTO of Allerguard, Guy Ayal, about the groundbreaking technology, how it works, and when it will be available to purchase.
What prompted you to create this device? Do you have a personal connection with severe food allergies?
Guy Ayal: My eldest daughter's best friend suffers from a severe food allergy, and I experienced first-hand the effect it has on the person and their immediate surroundings. Most notable for me was the effect on the quality of life – the experience of living in constant fear. Everything we do at Allerguard is basically to alleviate some of that fear.
How exactly does the device work?
The device is built on two main pillars. The first is the nano-chemical stage, in which we developed specially attuned nanoparticles that selectively adhere only to the specific molecules that we are looking for. Those molecules, once bound to the nanoparticles, induce a change in their electrical behavior, which is measured and analyzed by the second main pillar -- highly advanced machine learning algorithms, which can surmise which molecules were collected, and thus whether or not peanuts (or in the future, other allergens) were detected.
It is important to understand that just several years ago, this would not have been possible, because both the nano-chemistry, and especially the entire world of machine learning, big data, and what is commonly known as AI only started to exist in the '90s, and reached applicability for handheld devices only in the past few years.
Where are you at in the development process and when will the device be available to consumers?
We have concluded the proof of concept and proof of capability phase, when we demonstrated successful detection of the minimal known clinical amount that may cause the slightest effect in the most severely allergic person – less than 1 mg of peanut (actually it is 0.7 mg). Over the next 18 months will be productization, qualification, and validation of our device, which should be ready to market in the latter half of 2021. The sensor will be available in the U.S., and after a year in Europe and Canada.
The Allerguard was made possible through recent advances in machine learning, big data, and AI.
How much will it cost?
Our target price is about $200 for the device, with a disposable SenseCard that will run for at least a full day and cost about $1. That card is for a specific allergen and will work for multiple scans in a day, not just one time.
[At a later stage, the company will have sensors for other allergens like tree nuts, eggs, and milk, and they'll develop a multi-SenseCard that works for a few allergens at once.]
Are there any other devices on the market that do something similar to Allerguard?
No other devices are even close to supplying the level of service that we promise. All known methods for allergen detection rely on sampling of the food, which is a viable solution for homogenous foodstuffs, such as a factory testing their raw ingredients, but not for something as heterogenous as an actual dish – especially not for solid allergens such as peanuts, treenuts, or sesame.
If there is a single peanut in your plate, and you sample from anywhere on that plate which is not where that peanut is located, you will find that your sample is perfectly clean – because it is. But the dish is not. That dish is a death trap for an allergic person. Allerguard is the only suggested solution that could indeed detect that peanut, no matter where in that plate it is hiding.
Anything else readers should know?
Our first-generation product will be for peanuts only. You have to understand, we are still a start-up company, and if we don't concentrate our limited resources to one specific goal, we will not be able to achieve anything at all. Once we are ready to market our first device, the peanut detector, we will be able to start the R&D for the 2nd product, which will be for another allergen – most likely tree nuts and/or sesame, but that will probably be in debate until we actually start it.
The Friday Five covers five stories in research that you may have missed this week. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend.
Here are the promising studies covered in this week's Friday Five:
- Research on a "smart" bandage for wounds
- A breakthrough in fighting inflammation
- The pros and cons of a new drug for Alzheimer's
- Benefits of the Mediterranean diet - with a twist
- How to recycle a plastic that was un-recyclable
Sexually transmitted infections (STIs) are surging across the U.S. to 2.5 million cases in 2021 according to preliminary data from the CDC. A new prevention and treatment strategy now in clinical trials may provide a way to get a handle on them.
It's easy to overlook the soaring rates of gonorrhea, chlamydia, and syphilis because most of those infections have few or no symptoms and can be identified only through testing. But left untreated, they can lead to serious damage to nerves and tissue, resulting in infertility, blindness, and dementia. Infants developing in utero are particularly vulnerable.
Covid-19 played havoc with regular medical treatment and preventive care for many health problems, including STIs. After formal lockdowns ended, many people gradually became more socially engaged, with increases in sexual activity, and may have prioritized these activities over getting back in touch with their doctors.
A second blow to controlling STIs is that family planning clinics are closing left and right because of the Dobbs decision and legislation in many states that curtailed access to an abortion. Discussion has focused on abortion, but those same clinics also play a vital role in the diagnosis and treatment of STIs.
Routine public health is the neglected stepchild of medicine. It is called upon in times of crisis but as that crisis resolves, funding dries up. Labs have atrophied and personnel have been redirected to Covid, “so access to routine screening for STIs has been decimated,” says Jennifer Mahn, director of sexual and clinical health with the National Coalition of STD Directors.
A preview of what we likely are facing comes from Iowa. In 2017, the state legislature restricted funding to family health clinics in four counties, which closed their doors. A year later the statewide rate of gonorrhea skyrocketed from 83 to 153.7 cases per 100,000 people. “Iowa counties with clinic closures had a significantly larger increase,” according to a study published in JAMA. That scenario likely is playing out in countless other regions where access to sexual health care is shrinking; it will be many months before we have the data to know for sure.
A decades-old antibiotic finds a new purpose
Using drugs to protect against HIV, either as post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP), has proven to be quite successful. Researchers wondered if the same approach might be applied to other STIs. They focused on doxycycline, or doxy for short. One of the most commonly prescribed antibiotics in the U.S., it’s a member of the tetracycline family that has been on the market since 1967. It is so safe that it’s used to treat acne.
Two small studies using doxy suggested that it could work to prevent STIs. A handful of clinical trials by different researchers and funding sources set out to generate the additional evidence needed to prove their hypothesis and change the standard of care.
Senior researcher Victor Omollo, with the Kenya Medical Research Institute, noted, “These are prevention interventions that women can control on their own without having to seek or get consent from another person,” as is the case with condom use.
The first with results is the DoxyPEP study, conducted at two sexual health clinics in San Francisco and Seattle. It drew from a mix of transgender women and men who have sex with men, who had at least one diagnosed STI over the last year. The researchers divided the participants into two groups: one with people who were already HIV-positive and engaged in care, while the other group consisted of people who were on PrEP to prevent infection with HIV. For the active part of the study, a subset of the participants received doxy, and the rest of the participants did not.
The researchers intentionally chose to do the study in a population at the highest risk of having STIs, who were very health oriented, and “who were getting screened every three months or so as part of their PrEP program or their HIV care program,” says Connie Celum, a senior researcher at the University of Washington on the study.
Each member of the active group was given a supply of doxy and asked to take two pills within 72 hours of having sex where a condom was not used. The study was supposed to run for two years but, in May, it stopped halfway through, when a safety monitoring board looked at the data and recommended that it would be unethical to continue depriving the control group of the drug’s benefits.
Celum presented these preliminary results from the DoxyPEP study in July at the International AIDS Conference in Montreal. “We saw about a 56 percent reduction in gonorrhea, about 80 percent reduction in chlamydia and syphilis, so very significant reductions, and this is on a per quarter basis,” she told a later webinar.
In Kenya, another study is following a group of cisgender women who are taking the same two-pill regimen to prevent HIV, and the data from this research should become available in 2023. Senior researcher Victor Omollo, with the Kenya Medical Research Institute, noted that “these are prevention interventions that women can control on their own without having to seek or get consent from another person,” as is the case with condom use, another effective prevention tool.
Antibiotic resistance is a potentially big concern. About 25 percent of gonorrhea strains circulating in the U.S. are resistant to the tetracycline class of drugs, including doxy; rates are higher elsewhere. But resistance often is a matter of degree and can be overcome with a larger or longer dose of the drug, or perhaps with a switch to another drug or a two-drug combination.
Research has shown that an established bacterial infection is more difficult to treat because it is part of a biofilm, which can leave only a small portion or perhaps none of the cell surface exposed to a drug. But a new infection, even one where the bacteria is resistant to a drug, might still be vulnerable to that drug if it's used before the bacterial biofilm can be established. Preliminary data suggests that may be the case with doxyPEP and drug resistant gonorrhea; some but not all new drug resistant infections might be thwarted if they’re treated early enough.
“There are some tradeoffs” to these interventions, Celum says, and people may disagree on the cost of increased resistance balanced against the benefits of treating the STIs and reducing their spread within the community.
Resistance does not seem to be an issue yet for chlamydia and syphilis even though doxy has been a recommended treatment for decades, but a remaining question is whether broader use of doxy will directly worsen antibiotic resistance in gonorrhea, or promote it in other STIs. And how will it affect the gut microbiome?
In addition, Celum notes that we need to understand whether doxy will generate mutations in other bacteria that might contribute to drug resistance for gonorrhea, chlamydia or syphilis. The studies underway aim to provide data to answer these questions.
“There are some tradeoffs” to these interventions, Celum says, and people may disagree on the cost of increased resistance balanced against the benefits of treating the STIs and reducing their spread within the community. That might affect doctors' willingness to prescribe the drug.
Turning research into action
The CDC makes policy recommendations for prevention services such as taking doxy, requiring some and leaving others optional. Celum says the CDC will be reviewing information from her trial at a meeting in December, but probably will wait until that study is published before making recommendations, likely in 2023. The San Francisco Department of Public Health issued its own guidance on October 20th and anecdotally, some doctors around the country are beginning to issue prescriptions for doxy to select patients.
About half of new STIs occur in young people ages 15 to 24, a group that is least likely to regularly see a doctor. And sexual health remains a great taboo for many people who don't want such information on their health record for prying parents, employers or neighbors to find out.
“People will go out of their way and travel extensive distances just to avoid that,” says Mahn, the National Coalition director. “People identify locations where they feel safe, where they feel welcome, where they don't feel judged,” Mahn explains, such as community and family planning clinics. They understand those issues and have fees that vary depending on a person’s ability to pay.
Given that these clinics already are understaffed and underfunded, they will be hard pressed to expand services covering the labor intensive testing and monitoring of a doxyPEP regimen. Sexual health clinics don't even have a separate line item in the federal budget for health. That is something the National Association of STI Directors is pushing for in D.C.
DoxyPEP isn't a panacea, and it isn't for everyone. “We really want to try to reach that population who is most likely going to have an STI in the next year,” says Celum, “Because that's where you are going to have the biggest impact.”