Solution
Anaphylaxis is associated with PEG-contained products, PEGylated drugs and mRNA vaccines, as explicitly stated in the FDA-approved labels. 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 can cause discomfort and local reactions, such as itching and redness. In rare but severe cases, skin testing can trigger systemic adverse reactions, including life threatening anaphylaxis. These factors =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 general immunoassay platform based on paired or so called dual cytometric bead assay (DCBA). One of its applications is used as a non-invasive method to detect anti-PEG IgE antibodies in vitro, which are the primary cause of PEG anaphylaxis in the clinic. 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
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