Developing a diagnostic device to detect the early onset of severe allergies

Imagine you're relaxing at home when your throat starts to feel scratchy. You think it could be a cold coming on, so you think nothing of it, but then you remember you had takeout from a new restaurant earlier in the evening. Before you can begin to wonder whether they cooked your food in peanut oil (which you’re severely allergic to), your throat is closing up, making it more difficult to search for your epi-pen. Wouldn’t be nice to prevent such a traumatic event by having a device that can alert you before the onset of severe allergies?

The true global scale of anaphylaxis - the sudden onset of severe and potentially life-threatening symptoms that occur within minutes to hours of exposure to an allergen - remains unknown. Many episodes occur in the community without being reported to hospitals, and most areas have not yet developed reliable systems to monitor severe allergic events, including anaphylaxis. The challenge in quickly identifying anaphylaxis is that the symptoms are vague and many overlap with other diseases and illnesses, like cold or flu.

The challenges of diagnosing anaphylaxis

There are currently no objective ways to quantify allergic reactions and detect the early onset of anaphylaxis. Histamine is widely recognized as the most relevant biomarker for the detection of allergies. However, because of its extremely small size and short half-life, it is also a highly challenging target for sensor development. Currently, there are no diagnostic devices available that could detect histamine in the clinical range within minutes.

Even if we could detect histamine with existing technology, most devices used to detect and quantify disease biomarkers require multiple preparation steps before the actual measurement can be taken. This measurement often consists of looking at optical signatures (e.g., light absorption, fluorescence) that require sophisticated laboratory systems that have been difficult to miniaturize and fully integrate into cost-effective point-of-care devices.

Market penetration of electronic readout systems has also been limited. Though electronic microsensors have been widely accepted by the public and are routinely used by patients with diabetes to monitor their glucose levels, they are limited because blood and plasma components can rapidly clog up the sensor surface (an event called “fouling”) and dramatically limit sensor sensitivity.

So, in order to meet the need for a diagnostic system that can detect, quantify, and report histamine’s presence easily, rapidly, and with sensitivity that is clinically relevant, we have to solve multiple problems: develop a reliable histamine sensor, prevent the sensor from being fouled, and integrate it into a cheap, portable device.   

The Wyss approach

The Wyss Institute is developing a first-of-its-kind diagnostic device that detects and quantifies histamine, offering millions of people suffering from allergies an easy, potentially lifesaving way to manage their condition.

Our device, eRapid, is a multiplexed electrochemical platform with a proprietary nanocomposite material that prevents the accumulation of blood components at the sensor surface, retains electronic sensitivity, and is scalable for mass production. We demonstrated our coated sensors could retain over 88% of their sensitivity even after being stored for two months in whole human plasma.

We have repurposed our eRapid platform to develop a diagnostic tool to detect the early onset of allergies. Combining our proprietary nanocomposite sensor surfaces with our assay techniques for small target molecules, abbieSense can assess the severity of an allergic reaction within five minutes. This has been validated in human plasma and the whole test can be carried out in five minutes to detect clinically relevant concentrations of histamine, making it the first of its kind. When commercialized, the platform could potentially be used in a consumer test kit, or even a wearable sensor. Beyond allergies, eRapid will find wider applications in medical diagnostics, solving the problem of surface fouling that limits the widespread adoption of electronic microsensors in this field. 

As a Biosensor Lead under Prof. Donald E. Ingber, I am very excited to be working on a project that can positively impact millions of people in the US and beyond. Particularly, this project resonates because when I was young, I watched my own mother suffer from allergies and asthmatic attacks, which makes it even more rewarding. Having said that, there is a lot of work that needs to be done in this field, and I am proud of my team’s contributions.