Solution
Anaphylaxis is associated with PEG-contained products, PEGylated drugs and mRNA vaccines, as explicitly stated in their FDA-approved labels. In particular, 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 itself.
Skin testing is used to diagnose Type I hypersensitivity, but it has some drawbacks. In particular, skin testing can cause discomfort and local reactions, such as itching and redness. There is sometimes a risk of systemic adverse reactions, including anaphylaxis. These factors may reduce patient compliance. Therefore, a sensitive and reliable in vitro laboratory test should be a more acceptable option for patients.
Patented Platform
FocalTuningTM is a non-invasive in vitro detection platform designed to identify anti-PEG IgE antibodies, which are the primary cause of PEG anaphylaxis. This proprietary platform and products (US10,914,731B2, 2021; US11,835,517B2, 2023; ZL202080015982.5, 2024) fine-tunes the PEG-binding properties of antibodies to specifically recognize anti-PEG IgE antibodies without non-specific signal from the same sample, enabling accurate and sensitive detection of anti-PEG IgE positive patients at high risk for PEG anaphylaxis. By identifying at-risk patients, healthcare professionals can take appropriate action 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
Platform Features
♦Removing internal background of each analyte
♦Patented technology
♦Unbeatable accuracy
♥Tiny sample (100ul or less)
♦Super sensitive
♦High specificity
Signature Products
You also may purchase our products from your distributor AmCell Biosciencess, LLC at https://amcellbio.com/shop