Anaphylaxis is associated with PEGylated drugs and mRNA vaccines, as explicitly stated in their FDA-approved labels. Specifically, anaphylactic reactions to the PEG component of these drugs and vaccines have been reported in real-world practice, highlighting the need for improved safety measures targeting PEG in particular.
Skin tests are used to diagnose Type I hypersensitivity, but they have some downsides. Particularly skin tests can cause discomfort and localized reactions, such as itching and redness. Sometimes, there is a risk of systemic adverse reactions, including anaphylaxis. These factors may lead to lower patient compliance. For this reason, a sensitive in vitro lab test should be a more acceptable option for patients.
FocalTuningTM is an innovative in vitro detection platform designed to identify anti-PEG IgE antibodies, which are the primary cause of PEG anaphylaxis. This proprietary technology fine-tunes the PEG-binding properties of antibodies to specifically recognize anti-PEG IgE antibodies without any non-specific signal from the same sample, enabling accurate and sensitive detection of patients who are anti-PEG IgE positive and at high risk of PEG anaphylaxis. By identifying at-risk patients, healthcare professionals can take appropriate measures to prevent serious adverse events and provide personalized treatment options. The patented FocalTuningTM platform and signature PEG IgE detection products represent a promising approach to minimizing or even eliminating the growing concern of PEG-related severe immediate allergic reactions to PEGylated drugs in clinical settings.
FocalTuningTM Platform Flow Chart
♦Removing internal background of each analyte
♥Tiny sample needed (50ul)
You also may purchase our products from your distributor AmCell Biosciencess, LLC at https://amcellbio.com/shop