An estimated 32 million Americans, including around 5.6 million children and 26 million adults, suffer from food allergies. The severity of these food allergies ranges from hives and swelling of the face to difficulty breathing, abdominal pain and diarrhea. Currently one of the most common ways of testing for food allergies is a skin prick test that involves placing a small amount of a certain food on a patient’s skin to see if it will cause an adverse reaction.
This method is the most accessible food allergy test, and it usually provides immediate results, allowing patients to discuss means of dealing with the allergy with their allergist during a single hospital visit. However, a recent announcement from the U.S. Food and Drug Administration has revealed that skin tests for food allergies aren’t always effective. The FDA has revealed that commonly used skin tests can produce false negative results and give patients with potentially deadly allergies a false sense of security.
The March 3, 2023, announcement stated that these ineffective food allergy tests have been associated with anaphylaxis after patients were exposed to an allergen they had been led to believe wouldn’t affect them. According to the announcement, the FDA became aware of the presence of food-allergen skin tests that provided false results after analyzing data from the FDA Adverse Event Reporting System. The analysis found that there has been an increase in reports of false-negative tests after patients used certain skin tests to check for potential allergies.
Some of the reports seen by the FDA revealed that patients with peanut allergies faced the risk of life-threatening anaphylaxis after being exposed to peanuts due to false negative results.
The announcement came a few months after the FDA notified the public that food allergen skin test manufacturer ALK-Abelló Inc. had voluntarily withdrawn four lots of tests due to increased reports of false-negative tests.
Before the announcement of product recalls, the FDA had listed certain product lots that were increasingly associated with false-negative skin test results.
The FDA concluded that all allergenic extracts used to check for food allergies had a risk of providing negative skin-test results. It now requires all manufacturers of these allergenic extracts to include language explaining the risk of false results and anaphylaxis in the Warnings and Precautions section of their products’ Prescribing Information.
With better approaches to managing allergies being developed by enterprises such as Aditxt Inc. (NASDAQ: ADTX), the need for skin tests that have proven to be minimally reliable will decrease as novel approaches to allergy detection and management take root.
NOTE TO INVESTORS: The latest news and updates relating to Aditxt Inc. (NASDAQ: ADTX) are available in the company’s newsroom at https://ibn.fm/ADTX
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